Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to...

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Batch: PRODUCT INFORMATION Product common name Product Latin name SHELF-LIFE EXTENSIONS Plant part Product code Batch number Cultivation Herb : Liquid Ratio Alcoholic Strength Extracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia. Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs). Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities ANALYTICAL RESULTS Organolepsis 1 Appearance Conforms to specification Odour Conforms to specification Taste Conforms to specification 1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22. RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd Rutland Biodynamics Ltd (Herbal Medicines) Town Park Farm, Brooke, Rutland, LE15 8DG, UK UK Dept of Health MHRA cGMP MIA number 28255 www.rutlandbio.com Finished Product Certificate of Analysis

Transcript of Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to...

Page 1: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

Batch:

PRODUCT INFORMATION

Product common nameProduct Latin name SHELF-LIFE EXTENSIONS

Plant part Product codeBatch number

CultivationHerb : Liquid RatioAlcoholic Strength

Extracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

Organolepsis1

Appearance Conforms to specificationOdour Conforms to specificationTaste Conforms to specification

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 2: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

Batch:

PhytochemistryTotal dissolved solids2 Conforms to specification

HPLC N/A

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

Microbiology4

Total Aerobic Count (<104 cfu/ml) Conforms to Ph. Eur.Yeast and Mould (<102 cfu/ml) Conforms to Ph. Eur.

Bile tolerant gram negative bacteria (<102cfu/ml) Conforms to Ph. Eur.Absence of Escherichia coli Conforms to Ph. Eur.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Signed O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O MonksSigned O Monks

Page 3: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 4: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 5: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 6: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 7: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 8: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 9: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 10: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 11: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 12: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 13: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 14: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 15: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 16: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 17: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 18: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 19: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 20: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 21: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 22: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 23: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 24: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 25: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 26: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 27: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 28: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 29: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 30: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 31: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 32: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 33: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 34: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 35: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 36: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 37: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 38: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 39: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 40: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis

Page 41: Finished Product Certificate of Analysis Batch · 2019. 2. 7. · 2) Determination according to Rutland Biodynamics SOP C72. 4) All extracts comply with relevant aspects of the European

PRODUCT INFORMATIONExtracts are prepared by suitable methods using ethanol or other suitable solvents according to the General Extracts monograph of the European Pharmacopoeia (Monograph 0765). Herbal drugs and organic solvents used for the preparation of extracts comply with any relevant monograph of the Pharmacopoeia.

Herbal drugs are obtained from cultivated or wild plants. Suitable collection, cultivation, harvesting, drying, fragmentation and storage conditions are essential to guarantee the quality of herbal drugs. Herbal drugs are, as far as possible, free from impurities such as soil, dust, dirt and other contaminants such as fungal, insect and other animal contaminations in accordance with European Pharmacopoeia Monograph 1433 (Herbal Drugs).

Extracts are manufactured and sold under a Duty Free Excise Licence for use as an ingredient for inclusion in medicines only. Any other use by the recipient attracts full liability for Spirits duty which will be payable by the recipient on demand by the authorities

ANALYTICAL RESULTS

1) All extracts comply with the requirements of the European Pharmacopoeia for Herbal Drug Preparations Monograph 1434. Determination according to Rutland Biodynamics SOP C22.

Natural variations in the levels of constituents in different samples of a plant drug may lead to minor deviations from one chromatogram to another. The extent of deviation allowed before samples are considered unacceptable or contaminated with foreign material depends on experience and careful judgement. Samples are also evaluated in accordance with any relevant Pharmacopoeial monograph.

2) Determination according to Rutland Biodynamics SOP C72.

4) All extracts comply with relevant aspects of the European Monograph for Microbiological quality of herbal medicinal products for oral use (Monograph 5.1.8.). Determination according to Rutland Biodynamics SOP C61.

I hereby certify that the above tests have been carried out under the standard operational procedures of Rutland Biodynamics Ltd. and under Good Manufacturing Practice in conformance with the Company's current certificate of compliance with Good Manufacturing Practice (MIA 28255) laid down in Directive 2003/94/EC. This certificate and the results shown apply to the tested sample only. This report may not be used by third parties, including for promotional purposes, without the prior written permission of Rutland Biodynamics Ltd.

Date 18/09/13

RBD webCoA vs.3 Feb 2013 © Rutland Biodynamics Ltd

Rutland Biodynamics Ltd (Herbal Medicines)

Town Park Farm, Brooke, Rutland, LE15 8DG, UK

UK Dept of Health MHRA cGMP MIA number 28255

www.rutlandbio.com

Finished Product Certificate of Analysis