HERBAL MONOGRAPH OF ALOE BARBADENSIS (syn. ALOE … · 1 HERBAL MONOGRAPH OF ALOE BARBADENSIS (syn....

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1 HERBAL MONOGRAPH OF ALOE BARBADENSIS (syn. ALOE INDICA) Dried juice of leaves of Aloe barbadensis Mill.(Syn. A.vera(Linn).Burm.f., A.indica Royle); Fam.Liliaceae. The plant is distributed throughout India. INDIAN NAMES Sans. : Kumarirasasambhava, Ghrita- Kumari Beng. : Ghrita kumari Guj. : Kunwar Hindi : Musabhar, Ghikanwar Kan. : Kolasoare, Komarika, Maulisara Mal. : Kattavazha Mar. : Korphad Ori : Kumari, Mushabora Tam. : Chirukattalai, Kattalai Tel. : Kalabanda

Transcript of HERBAL MONOGRAPH OF ALOE BARBADENSIS (syn. ALOE … · 1 HERBAL MONOGRAPH OF ALOE BARBADENSIS (syn....

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HERBAL MONOGRAPH OF ALOE BARBADENSIS (syn. ALOE INDICA)

Dried juice of leaves of Aloe barbadensis Mill.(Syn. A.vera(Linn).Burm.f., A.indica Royle); Fam.Liliaceae. The plant is distributed throughout India. INDIAN NAMES

Sans. : Kumarirasasambhava, Ghrita- Kumari Beng. : Ghrita kumari Guj. : Kunwar Hindi : Musabhar, Ghikanwar Kan. : Kolasoare, Komarika, Maulisara Mal. : Kattavazha Mar. : Korphad Ori : Kumari, Mushabora Tam. : Chirukattalai, Kattalai Tel. : Kalabanda

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CHEMICAL CONSTITUENTS Major constituents includes Glycosides- Anthracene derivatives: Hydroxyanthraquinone derivatives(25-40) viz., aloin (=barbaloin, a mixture of aloin A & B, the diastereoisomeric 10-C glucosides of aloe-emodin anthrone) and 7-hydroxyaloin isomers.Indian aoles contain aloinosides as major constituents with only traces of aloin. Minor constituents includes aloeemodin, chrysophanol; chromone derivatives viz., aloeresin B (=aloesin, upto 30%) with its p-coumaryl derivatives aloeresins A & C and the aglycone aloesone. IDENTITY TESTS (FROM RAW MATERIALS) The drug answers tests for anthraquinone glycosides. Mix 0.5g with 50ml water, boil until nearly dissolved, cool and add 0.5gm of Kieselguhr and filter.

a) Heat 5ml of the filtrate with 0.2g of borax until dissolved, add a few drops of this solution to a test tube nearly filled with water, a green fluorescence is produced.

b) Mix 2ml of the filtrate with 2ml freshly prepared solution of bromine; a pale yellow precipitate is produced.

ASSAY / ANALYTICAL METHODS (FROM EXTRACTS) 1) Ascorbic acid estimation by HPLC method HPLC System : Shimatzu 2010 CHT HPLC with UV detector at 254 nm Column : C-18 Mobile phase : 5% Methanol in 0.01 M KH2PO4

Flow rate : 1ml/min Retention time : 2.60min Standard : Ascorbic acid As it is difficult to obtain an accurate quantification from the extract using Standard method, most companies do not carry out any analysis for the key phytochemical marker. Konark Herbals and Health Care believes in providing

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highly standardized extracts and hence all the quantification are done using HPLC. HPLC GRAPH -

2) Aloin estimations by Gravimetric method. 3) Total phenolics by spectrophometric method KHHC constantly innovate and upgrades its products and testing methods. We suggest you to review our website providing regular updates. PESTICIDES LIMITS A limit for pesticide is one of the major issues in standardization of medicinal plants and products in view of the worldwide widespread use of pesticides in cultivated plants. The presence of pesticides in extracts increase the health risk by many folds. The pesticides can be extremely irritant on skin as well as in the internal organs, it is essential to monitor its concentration as a part of GMP. Various analytical methods for the quantitative determination of pesticides by gas chromatography coupled with mass-spectrophotometer are in use. Konark

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Research Foundation (KRF), a NABL certified lab is well equipped with the latest technology and instruments and monitors the pesticide limit as part of its GMP. CHROMATOGRAPHIC PROFILE From the pharmacopoeial perspective, a better quality control of raw material can be achieved by specifying a quantitative test procedure for the determination of the range or a minimum content by specifying a quantitative test procedure for the determination of the range or a minimum content of the marker substances or the ‘active’ ingredient. A chromatographic finger profile represents qualitative/ quantitative determination of various components present in a complex plant extract irrespective whether or not their exact identity is known. Thin layer chromatographic technique is the simplest and least expensive method that provides plenty of information on the composition of raw herbs and its preparation. For quantitative analysis of active ingredients or marker substances with simultaneous separation and detection High Pressure liquid chromatography is the best technique. We use the latest model of HPLC for all its analysis. LIMITS FOR IMPURITIES A test requirement for foreign organic matter would ensure the extent of contamination of extraneous matters such as filth and other parts of botanicals not covered by the definition of the herbal drug. Since sand and soil are predictable contaminants of botanicals, test requirements for ‘total ash’, water soluble ash’, ‘acid soluble ash’, residue on ignition and sulphated ash would be expected to limit such contaminants.Test requirement for heavy metals in botanical raw material are probably more relevant for parts of plants growing under ground than for the aerial parts of the plant. The presence of high levels of minerals interact with the final product there by affecting its keeping quality. MICROBIAL LIMITS If the raw herb is to be used directly without boiling in water prior to consumption, restrictive limits on microbial contaminants are required for pathogens such as Salmonella sp. Enterobacter and E.coli which are causative agent for various gastro-intestinal diseases. A lower level of yeasts and molds and a limit on total aerobes are considered appropriate in plant material for topical use. The presence of aflatoxins detected by chemical means is generally

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independent of the number of viable molds that are detected using microbiological methods. Aflatoxins in microgram quantity are capable of giving serious hypersentivity reactions which can be extremely harmful to human health. APPLICATION Cathartic action of the drug, limited to large intestine, is attributed to anthraquinone glycosides, chiefly aloin. Latter is not absorbed in the upper gut but hydrolysed to the active aglycone at the site of action in the colon and rectum by intestinal bacteria.The anthrones irritate the mucus membrane, leading to an increase in the secretion of mucus, thus stimulating peristalsis. Also they induce an active secretion of water and electrolytes into the lumen of the gut and inhibit the absorption of electrolytes and water by the colon. REPORTED ACTIVITIES

• Immunomodulatory, • Wound healing, • Anticancer, • Radioprotective efficacy, • Angiogenic, • Antiviral, • Analgesic • Anti-inflammatory, • Hypotensive.

USES

• Burn and Wound Healing: Typically the wound healing requires regeneration of skin and closing of the wound. Aloe Vera is soothing in nature due to its moisture content. Studies show that Aloe Vera when applied to a wound increases the rate of wound closure and enhances the proliferation of cells, whereby the healing is enhanced.

• Aging of the Skin: Components of Aloe Vera have been found to reverse degenerative skin changes by stimulating collagen and elastin synthesis.

• Immune System Restoration: Research has proven that Aloe Vera improves skin's immune system.. It protects against the UV radiation.

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• Moisturizer: Aloe Vera improves the skin's ability to hydrate itself, aids in the removal of dead skin cells and has an effective penetrating ability that helps transport healthy substances through the skin.

• Arthritis, Joint and Muscle Pain: Aloe Vera is believed to reduce severe joint and muscle pain associated with arthritis, tendinitis and other injuries. When applied directly to the area of pain, Aloe Vera penetrates the skin to soothe the pain.

• Relieve Gastrointestinal Problems: • Coronary Heart Disease Studies suggest that the ingestion of Aloe Vera

gel may have a beneficial effect to the accumulation of blood fat lipids associated with the disease.

• Blood circulation - a number of constituents have beneficial effects on blood pressure and coagulation.

• Digestion - One of its most popular uses is in helping any type of digestive or bowel disorder. It has a gentle laxative effect on the bowels.

• For Konark complexes like- Konark DAN.

IMPORTANT SITES FOR RESEARCH IN ALOEVERA PRODUCTS 1)http://www3.interscience.wiley.com/journal/117953984/abstract?CRETRY=1&SRETRY=0 Anti-sickling potential of Aloe vera extract The effect of Aloe vera extract on the gelling time of human HbSS erythrocytes was investigated. The results showed that A.. vera extract increased the gelling time of HbSS blood and inhibited sickling in vitro. In addition, a linear relationship was found between extract concentration and gelling time, suggesting that A.. vera extract may have great potential in the management of sickle cell disease. 2) http://www.internethealthlibrary.com/Plant-Remedies/AloeVera-research.htm Some recent studies appear to show topical and orally administered aloe vera preparations in patients with angina and heart disease, diabetes, psroiasis, wound healing and chronic venous leg ulcers. 3) http://www.dietahoodia.com/dieta-hoodia/investigaciones---research-papers-on-hoodia-aloe-chia-noni/investigaciones---research-papers-on-aloe

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a) J Wound Care. 2004 Apr;13(4):157-8.: Phytotherapy: an alternative treatment for non-healing ulcers.Avijgan M.Shahr-e-kord University of Medical Sciences, Shahr-e-kord, Iran. [email protected] b) Int Immunopharmacol. 2004 Mar;4(3):411-8.: Mannan from Aloe saponaria inhibits tumoral cell activation and proliferation. c) Effects of Aloe Extracts on Human Normal & Tumor Cells In-VitroWinters WD; Benavides R; Clouse WJ (Dep. Microbiol., Univ. Tex. Health Sci. Center Econ Bot 35 (1), 1981, 89-95). d) Anticancer Effects of Aloe on Sarcoma 180 in ICR Mouse & On Human Cancer Cell Lines. (Jeong HY; Kim JH; Hwang SJ; Rhee DKColl. Pharm., Sung Kyun Kwan Univ Yakhak Hoeji 38 (3). 1994. 311-321)

4) www.pubmed.gov

• Antioxidant/Lipoxygenase Inhibitory Activities and Chemical Compositions of Selected Essential Oils.(Wei A, Shibamoto T. J Agric Food Chem. 2010 May 25).

• Toxicological evaluation of aqueous extract of Aloe ferox Mill. in loperamide-induced constipated rats.(Wintola OA, Sunmonu TO, Afolayan A.Hum Exp Toxicol. 2010 May 24. [Epub ahead of print]PMID: 20498033

• Synthesis of cytotoxic and antioxidant Schiff's base analogs of aloin.(Kumar S, Matharasi DP, Gopi S, Sivakumar S, Narasimhan S.J Asian Nat Prod Res. 2010 May;12(5):360-70.PMID: 20496193)

• Alternative therapies for common dermatologic disorders, part 2.(Morelli V, Calmet E, Jhingade V.Prim Care. 2010 Jun;37(2):285-96.PMID: 20493337)

• A novel method for air drying aloe leaf slices by covering with filter papers as a shrink-proof layer.(Kim SA, Baek JH, Lee SJ, Choi SY, Hur W, Lee SY.J Food Sci. 2009 Nov-Dec; 74(9):E462-70.PMID: 20492108).

• Medicinal plants used by traditional medicine practitioners for the treatment of HIV/AIDS and related conditions in Uganda.(Lamorde M, Tabuti JR, Obua C, Kukunda-Byobona C, Lanyero H, Byakika-Kibwika P, Bbosa GS, Lubega A, Ogwal-Okeng J, Ryan M, Waako PJ, Merry C.J Ethnopharmacol. 2010 May 6. [Epub ahead of print]PMID: 20451595)

• Neurotrophins and acupuncture.(Manni L, Albanesi M, Guaragna M, Barbaro Paparo S, Aloe L.Auton Neurosci. 2010 May 7. [Epub ahead of print]PMID: 20451467)

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• Ocular Application of Nerve Growth Factor Protects Degenerating Retinal Ganglion Cells in a Rat Model of Glaucoma.(Colafrancesco V, Parisi V, Sposato V, Rossi S, Russo MA, Coassin M, Lambiase A, Aloe L.J Glaucoma. 2010 Apr 29. [Epub ahead of print]PMID: 20436364).

• Protective effects of Aloe vera extract on mitochondria of neuronal cells and rat brain.(Wang Y, Cao L, Du G.Zhongguo Zhong Yao Za Zhi. 2010 Feb;35(3):364-8. Chinese. PMID: 20423007

• An extensive alien plant inventory from the inhabited areas of galapagos.Guézou A, Trueman M, Buddenhagen CE, Chamorro S, Guerrero AM, Pozo P, Atkinson R.PLoS One. 2010 Apr 21;5(4):e10276.PMID: 20421999.

• Ultrasonic cell grinder extraction of anthraquinones from Radix et Rhizoma Rhei and determination by ultra-performance liquid chromatography.Wang GY, Qi HY, Shi YP.J Sep Sci. 2010 Apr 19. [Epub ahead of print]PMID: 20405483

• Emodin, aloe-emodin and rhein induced DNA damage and inhibited DNA repair gene expression in SCC-4 human tongue cancer cells.Chen YY, Chiang SY, Lin JG, Yang JS, Ma YS, Liao CL, Lai TY, Tang NY, Chung JG.Anticancer Res. 2010 Mar;30(3):945-51.PMID: 20393018.

• Heavy metal bioaccumulation in selected medicinal plants collected from Khetri copper mines and comparison with those collected from fertile soil in Haridwar, India.Maharia RS, Dutta RK, Acharya R, Reddy AV.J Environ Sci Health B. 2010 Feb;45(2):174-81.PMID: 20390948.

• Effects of enhanced UV-B radiation on leaf anthraquinones content and cell ultrastructure of Aloe vera L.Wang HX, Yang TW, Li JY.Ying Yong Sheng Tai Xue Bao. 2010 Jan;21(1):260-4. Chinese. PMID: 20387453.

• High prevalence of abscesses and self-treatment among injection drug users in Tijuana, Mexico.Pollini RA, Gallardo M, Hasan S, Minuto J, Lozada R, Vera A, Zúñiga ML, Strathdee SA.Int J Infect Dis. 2010 Apr 6. [Epub ahead of print]PMID: 20381396.

• Emodin, aloe-emodin and rhein inhibit migration and invasion in human tongue cancer SCC-4 cells through the inhibition of gene expression of matrix metalloproteinase-9.Chen YY, Chiang SY, Lin JG, Ma YS, Liao CL, Weng SW, Lai TY, Chung JG.Int J Oncol. 2010 May;36(5):1113-20.PMID: 20372784.

• Effect of aloe cream versus silver sulfadiazine for healing burn wounds in rats.Hosseinimehr SJ, Khorasani G, Azadbakht M, Zamani P, Ghasemi M, Ahmadi A.Acta Dermatovenerol Croat. 2010;18(1):2-7.PMID: 20361881.

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• In vivo evidence of the immunomodulatory activity of orally administered Aloe vera gel.Im SA, Lee YR, Lee YH, Lee MK, Park YI, Lee S, Kim K, Lee CK.Arch Pharm Res. 2010 Mar;33(3):451-6. Epub 2010 Mar 30.PMID: 20361311.

• Implications for degenerative disorders: Antioxidative activity, total phenols, flavonoids, ascorbic acid, beta-carotene and beta-tocopherol in Aloe vera.Ozsoy N, Candoken E, Akev N.Oxid Med Cell Longev. 2009 Apr; 2(2):99-106.PMID: 20357932.

• Antifungal activities of Ocimum sanctum essential oil and its lead molecules.Khan A, Ahmad A, Manzoor N, Khan LA.Nat Prod Commun. 2010 Feb; 5(2):345-9.PMID: 20334156.

VARIOUS PRODUCTS 1) Aloevera Dry Extract- Premium, Standard and EC grade 2) Aloevera Soft Extract- Premium, Standard and EC grade 3) Aloevera Liquid Extract- Premium, Standard and EC grade 4) Aloevera Oil Soluble Extract- Premium, Standard and EC grade In all we have 12 varieties of Aloevera extracts.

PACKING SIZES/ QUANTITY DETAILS: Products Premium Standard EC Dry Extracts 5kgs 10kgs 10kgs Soft Extracts 5kgs 10kgs 10kgs Liquid Extracts 5kgs 10kgs 10kgs Oil Soluble Extracts 5kgs 10kgs 10kgs Samples are available in 50gms and above to our esteemed clients. REFERENCES:

1. Indian Herbal Pharmacopoeia (Revised New Edition 2002). 2. Standardization of Botanicals, Volume 2- By Dr. V. Rajpal. 3. www.pubmed.gov

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PRODUCT SPECIFICATION

Product Name Aloevera Dry Extract - PREMIUM Botanical Name Aloe indica Strength 6:1 Part Used Leaves Batch No. KH/AI//0 Manufacturing Date Date of release

TEST RESULT METHOD STANDARD REFERENCE

Nature Visual Fine Powder ”ASU” Protocol Color Visual Brown ”ASU” Protocol Taste Sensory Perception Astringent ”ASU” Protocol Odour Smell Characteristic ”ASU” Protocol Particle Size NLT 90% (through 80

mesh) 80 mesh sieve ”ASU” Protocol

Solubility in Water Visual Soluble ”ASU” Protocol Tap Density Mechanical 0.2 to 0.7gm/ml ”ASU” Protocol PHYSICOCHEMICAL ANALYSIS Loss on Drying Gravimetric NLT 5% API / IP 2007 Water soluble extractive

Maceration NLT-80% API / IP 2007

Alcohol soluble extractive

Maceration -------- API / IP 2007

pH (1%w/v Aq.Sol.) pH meter 3 to 7 API / IP 2007 IDENTIFICATION TEST Identification TLC Positive IP 2007 PHYTOCHEMICAL ANALYSIS Aloin Spectrophotometric

method NLT-1.0% Quality standard of Indian

Medicinal Plant HEAVY METAL ANALYSIS Arsenic By AAS NMT-3 ppm BP 2007,”ASU” Protocol Lead By AAS NMT-10 ppm BP 2007,”ASU” Protocol Mercury By AAS NMT-1 ppm BP 2007,”ASU” Protocol Cadmium By AAS NMT-0.3 ppm BP 2007,”ASU” Protocol MYCOTOXIN ANALYSIS Aflatoxins (B1+B2+G1+G2)

By HPLC 0.5+0.1+0.5+0.1 ppm

USP (561),”ASU” Protocol

MICROBIOLOGICAL PROFILE Total Plate Count Pour Plate Method NMT-

500cfu/gm USP (61)(62), “ASU” Protocol

Yeast & Mould Pour Plate Method NMT-102

cfu/gm USP (61)(62), “ASU” Protocol

Salmonella sp. Identification Absent USP (61)(62), “ASU”

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Method Protocol Escherichia. Coli Identification

Method Absent USP (61)(62), “ASU”

Protocol Pseudomonas aeroginosa

Identification Method

Absent USP (61)(62), “ASU” Protocol

Staphylococcus aureus

Identification Method

Absent USP (61)(62), “ASU” Protocol

Total Coliforms Pour Plate Method NMT-10 cfu/gm USP (61)(62), “ASU” Protocol

PESTICIDE RESIDUE ANALYSIS Alachlor GC Method NMT-0.02

ppm “ASU” Protocol, WHO Guideline

Aldrin and dieldrin (sum of )

GC Method NMT-0.05 ppm

“ASU” Protocol, WHO Guideline

Chlorpyrifos GC Method NMT-0.2 ppm

“ASU” Protocol, WHO Guideline

DDT(sum of p,p-DDT,o,p-DDT,p,p-DDE and p,p-TDE

GC Method NMT-1.0 ppm

“ASU” Protocol, WHO Guideline

Endosulfan(sum of isomers and Endosulfan Sulphate)

GC Method NMT-3.0 ppm

“ASU” Protocol, WHO Guideline

Ethion GC Method NMT-2.0 ppm

“ASU” Protocol, WHO Guideline

Hexachlorobenzene GC Method NMT-0.1 ppm

“ASU” Protocol, WHO Guideline

Hexachlorocyclohexane isomers(other then a)

GC Method NMT-0.3 ppm

“ASU” Protocol, WHO Guideline

Lindane GC Method NMT-0.6 ppm

“ASU” Protocol, WHO Guideline

Malathion GC Method NMT-1.0 ppm

“ASU” Protocol, WHO Guideline

STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: 2 years from the date of manufactured, if store under recommended conditions. WARNING: Once the package is opened it should be used at same time or it should be sealed immediately. Analysed By Approved By

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PRODUCT SPECIFICATION

Product Name Aloevera Dry Extract - STANDARD Botanical Name Aloe indica Strength 3:1 Part Used Leaves Batch No. KH/AI// Manufacturing Date Date of release

TEST RESULT METHOD STANDARD REFERENCE

PHYSICAL ANALYSIS

Nature Visual Fine Powder ”ASU” Protocol Color Visual Brown ”ASU” Protocol Taste Sensory Perception Astringent ”ASU” Protocol Odour Smell Characteristic ”ASU” Protocol Particle Size NLT 90% (through

80 mesh) 80 mesh sieve ”ASU” Protocol

Solubility in Water Visual Soluble ”ASU” Protocol Tap Density Mechanical 0.2 to 0.7gm/ml ”ASU” Protocol PHYSICOCHEMICAL ANALYSIS Loss on Drying Gravimetric NLT 5% API / IP 2007 Water soluble extractive

Maceration NLT-80% API / IP 2007

Alcohol soluble extractive

Maceration -------- API / IP 2007

pH (1%w/v Aq.Sol.) pH meter 3 to 7 API / IP 2007 IDENTIFICATION TEST Identification TLC Positive IP 2007 PHYTOCHEMICAL ANALYSIS Aloin Spectrophotometric

method Present Quality standard of Indian

Medicinal Plant HEAVY METAL ANALYSIS Arsenic By AAS NMT-3 ppm BP 2007,”ASU” Protocol Lead By AAS NMT-10 ppm BP 2007,”ASU” Protocol MICROBIOLOGICAL PROFILE Total Plate Count Pour Plate Method NMT-103 cfu/gm USP (61)(62), “ASU”

Protocol Yeast & Mould Pour Plate Method NMT-102 cfu/gm USP (61)(62), “ASU”

Protocol Salmonella sp. Identification

Method Absent USP (61)(62), “ASU”

Protocol Escherichia. Coli Identification

Method Absent USP (61)(62), “ASU”

Protocol Pseudomonas aeroginosa

Identification Method

Absent USP (61)(62), “ASU” Protocol

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Staphylococcus aureus

Identification Method

Absent USP (61)(62), “ASU” Protocol

Total Coliforms Pour Plate Method NMT-10 cfu/gm USP (61)(62), “ASU” Protocol

PESTICIDE RESIDUE ANALYSIS Alachlor GC Method NMT-0.02

ppm “ASU” Protocol, WHO Guideline

Aldrin and dieldrin (sum of )

GC Method NMT-0.05 ppm

“ASU” Protocol, WHO Guideline

Chlorpyrifos GC Method NMT-0.2 ppm

“ASU” Protocol, WHO Guideline

DDT(sum of p,p-DDT,o,p-DDT,p,p-DDE and p,p-TDE

GC Method NMT-1.0 ppm

“ASU” Protocol, WHO Guideline

STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: 2 years from the date of manufactured, if store under recommended conditions. WARNING: Once the package is opened it should be used at same time or it should be sealed immediately. Analysed By Approved By

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PRODUCT SPECIFICATION

Product Name Aloevera Dry Extract –EC grade Botanical Name Aloe indica Strength 2:1 Part Used Leaves Batch No. KH/AI// Manufacturing Date Date of release

TEST RESULT METHOD STANDARD REFERENCE

PHYSICAL ANALYSIS

Nature Visual Fine Powder ”ASU” Protocol Color Visual Brown ”ASU” Protocol Taste Sensory Perception Astringent ”ASU” Protocol Odour Smell Characteristic ”ASU” Protocol Particle Size NLT 90% (through

80 mesh) 80 mesh sieve ”ASU” Protocol

Solubility in Water Visual Soluble ”ASU” Protocol Tap Density Mechanical 0.2 to 0.7gm/ml ”ASU” Protocol PHYSICOCHEMICAL ANALYSIS Loss on Drying Gravimetric NLT 5% API / IP 2007 Water soluble extractive

Maceration NLT-80% API / IP 2007

Alcohol soluble extractive

Maceration -------- API / IP 2007

pH (1%w/v Aq.Sol.) pH meter 3 to 7 API / IP 2007 IDENTIFICATION TEST Identification TLC Positive IP 2007 PHYTOCHEMICAL ANALYSIS Aloin Spectrophotometric

method Present Quality standard of Indian

Medicinal Plant MICROBIOLOGICAL PROFILE Total Plate Count Pour Plate Method NMT-103 cfu/gm USP (61)(62), “ASU”

Protocol Yeast & Mould Pour Plate Method NMT-102 cfu/gm USP (61)(62), “ASU”

Protocol Total Coliforms Pour Plate Method NMT-10 cfu/gm USP (61)(62), “ASU”

Protocol STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: 2 years from the date of manufactured, if store under recommended conditions. WARNING: Once the package is opened it should be used at same time or it should be sealed immediately. Analysed By Approved By

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PRODUCT SPECIFICATION

1. Name of the Product :Aloe indica, Aloevera Liquid Extract -PREMIUM 2. Batch Number : KH/AI// 3. Mfg. Date : 4. Date of Analysis : 5. Part of the Plant Used : Leaves 6. Ratio : 6:1

Sr. No.

Test Standards Results Test Method/Reference

A Physico chemical Tests

1. Color Pale yellow to pale brown Visual, ASU protocol 2. Odor Characteristic Organoleptic, ASU

protocol 3. Water Solubility Soluble IP-2007 4. Propylene glycol

Solubility Soluble IP-2007

5. Alcohol Solubility (50% alcohol)

Soluble IP-2007

6. pH (1% w/v aqueous solution)

4.0-6.0 IP-2007

7. Specific Gravity (20°C) 1.020-1.050 IP-2007 8. Dry Residue (% -

105°C) 0.5% - 1.5% IP-2007

B. Heavy Metals 9. Lead 10 ppm BP-2007 “ASU”

Protocol 10 Arsenic 3 ppm BP-2007 “ASU”

Protocol 11. Mercury 1 ppm BP-2007 “ASU”

Protocol 12. Cadmium 0.3 ppm BP-2007 “ASU”

Protocol C. Markers 13. Total Phenolics

2-50% In house by

colorimetric method 14. Ascorbic acid 1- 100 ppm HPLC method D. Mycotoxin 15 Aflatoxins

(B1+B2+G1+G2) NMT 0.5+0.1+0.5+0.1

ppm By HPLC, USP

(561),”ASU” Protocol

E Pesticide residue Analysis

16 Alachlor NMT 0.02 ppm BY GC(“ASU” Protocol, WHO Guideline)

17 Aldrin and Dieldrin (Sum of )

NMT 0.05 ppm BY GC(“ASU” Protocol, WHO

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Guideline 18 Chlorpyrifos NMT 0.2 ppm BY GC(“ASU”

Protocol, WHO Guideline

19 DDT(Sum Of P,P-DDT,O,P-DDT,P,P-DDE And P,P-TDE

NMT 1.0 ppm BY GC(“ASU” Protocol, WHO Guideline

20 Endosulfan(Sum Of Isomers And Endosulfan Sulphate)

NMT 3.0 ppm BY GC(“ASU” Protocol, WHO Guideline

21 Ethion NMT 2.0 ppm BY GC(“ASU” Protocol, WHO Guideline

22 Hexachlorobenzene NMT 0.1 ppm BY GC(“ASU” Protocol, WHO Guideline

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Hexachlorocyclohexane Isomers(Other then A)

NMT 0.3 ppm BY GC(“ASU” Protocol, WHO Guideline

24 Lindane NMT 0.6 ppm BY GC(“ASU” Protocol, WHO Guideline

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Malathion NMT 1.0 ppm BY GC(“ASU” Protocol, WHO Guideline

D. Microbiological Tests 26. Total Aerobic Bacteria NMT 500 cfu/gm “ASU” Protocol 27. Yeast and Moulds NMT 100 cfu/gm “ASU” Protocol 28. Salmonella sp. Absent “ASU” Protocol 29. Escherichia. Coli Absent “ASU” Protocol 30. Pseudomonas

aeroginosa Absent “ASU” Protocol

31. Staphylococcus aureus Absent “ASU” Protocol 32. Total Coliforms NMT 10 cfu/gm “ASU” Protocol

Shelf Life : One year. For use after prescribed period, re-test. Storage Conditions : Cool, Dry and dark clean place. Temperature not exceeding 25oC. Refrigerate after opening the seal and consume within 15days thereof. OPINION OF ANALYST : The above material complies with the prescribed standards. Analyzed By Approved By The values stated above for the product is not valid if, the seal has been tampered or if changes are seen in the product due to improper handling. Phytochemicals present are likely to degrade over a period of time and the values stated are as on date of analysis. This is a natural product will darken

with Age, protect from oxidation. ** - Vitamin C, the photochemical analyzed, is a crucial ingredient in any cosmetic preparation,

valued for its antioxidant property. Vitamin C and Phenolics can be used as a marker for obtaining a high quality standardized product.

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PRODUCT SPECIFICATION

1. Name of the Product : Aloe indica, Aloevera Liquid Extract -STANDARD 2. Batch Number : KH/AI// 3. Mfg. Date : 4. Date of Analysis : 5. Part of the Plant Used : Leaves 6. Ratio :4:1

Sr. No.

Test Standards Results Test Method/Reference

A Physico chemical Tests

1. Color Pale yellow to pale brown Visual, ASU protocol 2. Odor Characteristic Organoleptic, ASU

protocol 3. Water Solubility Soluble IP-2007 4. Propylene glycol

Solubility Soluble IP-2007

5. Alcohol Solubility (50% alcohol)

Soluble IP-2007

6. pH (1% w/v aqueous solution)

4.0-6.0 IP-2007

7. Specific Gravity (20°C) 1.020-1.050 IP-2007 8. Dry Residue (% -

105°C) 0.5% - 1.5% IP-2007

B. Heavy Metals 9. Lead 10 ppm BP-2007 “ASU”

Protocol 10 Arsenic 3 ppm BP-2007 “ASU”

Protocol C. Markers 11. Ascorbic acid Present In house by

Colorimetric method E Pesticide residue

Analysis

12 Aldrin and Dieldrin (Sum of )

NMT 0.05 ppm BY GC(“ASU” Protocol, WHO Guideline

13 DDT(Sum Of P,P-DDT,O,P-DDT,P,P-DDE And P,P-TDE

NMT 1.0 ppm BY GC(“ASU” Protocol, WHO Guideline

D. Microbiological Tests 14. Total Aerobic Bacteria NMT 1000 cfu/gm “ASU” Protocol 15. Yeast and Moulds NMT 100 cfu/gm “ASU” Protocol 16. Total Coliforms NMT 10 cfu/gm “ASU” Protocol

Shelf Life : One year. For use after prescribed period, re-test. Storage Conditions : Cool, Dry and dark clean place. Temperature not exceeding 25oC. Refrigerate after opening the seal and consume within 15days thereof.

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OPINION OF ANALYST : The above material complies with the prescribed standards. Analyzed By Approved By The values stated above for the product is not valid if, the seal has been tampered or if changes are seen in the product due to improper handling. Phytochemicals present are likely to degrade over a period of time and the values stated are as on date of analysis. This is a natural product will darken

with Age, protect from oxidation.

19

PRODUCT SPECIFICATION

1. Name of the Product : Aloe indica ,Aloevera Liquid Extract –EC grade 2. Batch Number : KH/EO// 3. Mfg. Date : 4. Date of Analysis : 5. Part of the Plant Used : Fruit 6. Ratio : 4:1

Sr. No.

Test Standards Results Test Method/Reference

A Physico chemical Tests

1. Color Pale yellow to pale brown Visual, ASU protocol 2. Odor Characteristic Organoleptic, ASU

protocol 3. Water Solubility Soluble IP-2007 4. Propylene glycol

Solubility Soluble IP-2007

5. Alcohol Solubility (50% alcohol)

Soluble IP-2007

6. pH (1% w/v aqueous solution)

4.0-6.0 IP-2007

7. Dry Residue (% - 105°C)

0.5% - 1.5% IP-2007

C. Markers 8. Ascorbic acid Present In house by

Colorimetric method D. Microbiological Tests 9. Total Aerobic Bacteria NMT 1000 cfu/gm “ASU” Protocol 10. Yeast and Moulds NMT 100 cfu/gm “ASU” Protocol 11. Total Coliforms NMT 10 cfu/gm “ASU” Protocol

Shelf Life : One year. For use after prescribed period, re-test. Storage Conditions : Cool, Dry and dark clean place. Temperature not exceeding 25oC. Refrigerate after opening the seal and consume within 15days thereof. OPINION OF ANALYST : The above material complies with the prescribed standards. Analyzed By Approved By The values stated above for the product is not valid if, the seal has been tampered or if changes are seen in the product due to improper handling. Phytochemicals present are likely to degrade over a period of time and the values stated are as on date of analysis. This is a natural product will darken

with Age, protect from oxidation.

20

PRODUCT SPECIFICATION 1. Name of the Product : Aloe indica,Aloevera Soft Extract- PREMIUM 2. Strength : 5:1 3. Batch Number : KH/AI/S// 4. Mfg. Date : 5. Date of Analysis : 6. Part of the Plant Used : Leaves

Sr. No.

Test Results Standards Test Method/Reference

A Physico chemical Tests 1. Description Brown colored thick

paste with Characteristic odour & taste.

Visual, ASU protocol

2. Identification Test – by TLC

Positive IP-2007

3. Water Soluble Extractive as per IP’66

NLT-80% IP-2007

4. Alcohol Soluble Extractive as per IP’66

--------- IP-2007

5. Moisture Content

NMT 20% IP-2007

6. pH (1% w/v aqueous solution)

3-7 IP-2007

B Active Ingredient 7.

Aloin((By spectrophotometer

method) NLT-0.5% Quality standard of

Indian Medicinal Plant

C Heavy metals 8 Arsenic NMT 1 ppm BP-2007 “ASU”

Protocol 9 Lead NMT 10 ppm BP-2007 “ASU”

Protocol 10 Mercury NMT 1 ppm BP-2007 “ASU”

Protocol 11 Cadmium NMT 0.3 ppm BP-2007 “ASU”

Protocol D

Microbiological Tests

12. Total Aerobic Bacteria NMT 1000 cfu/gm “ASU” Protocol 13. Yeast and Moulds NMT 100 cfu/gm “ASU” Protocol 17. Salmonella sp. Absent “ASU” Protocol 15. Escherichia. Coli Absent “ASU” Protocol 16. Pseudomonas aeroginosa Absent “ASU” Protocol 17. Staphylococcus aureus Absent “ASU” Protocol 18. Total Coliforms NMT 10 cfu/gm “ASU” Protocol

21

STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: 2 years from the date of manufactured, if store under recommended conditions. WARNING: Once the package is opened it should be used at same time or it should be sealed immediately. Analysed By Approved By

22

PRODUCT SPECIFICATION 1. Name of the Product : Aloe indica, Aloevera Soft Extract- STANDARD 2. Strength : 3:1 3. Batch Number : KH/AI/S// 4. Mfg. Date : 5. Date of Analysis : 6. Part of the Plant Used : Leaves

Sr. No.

Test Results Standards Test Method/Reference

A Physico chemical Tests 1. Description Brown colored thick

paste with Characteristic odour & taste.

Visual, ASU protocol

2. Identification Test – by TLC

Positive IP-2007

3. Water Soluble Extractive as per IP’66

NLT-80% IP-2007

4. Alcohol Soluble Extractive as per IP’66

--------- IP-2007

5. Moisture Content

NMT 20% IP-2007

6. pH (1% w/v aqueous solution)

3-7 IP-2007

B Active Ingredient 7.

Aloin((By spectrophotometer

method) Present Quality standard of

Indian Medicinal Plant

C Heavy metals 8 Arsenic NMT 1 ppm BP-2007 “ASU”

Protocol 9 Lead NMT 10 ppm BP-2007 “ASU”

Protocol D

Microbiological Tests

10. Total Aerobic Bacteria NMT 1000 cfu/gm “ASU” Protocol 11. Yeast and Moulds NMT 100 cfu/gm “ASU” Protocol 12. Staphylococcus aureus Absent “ASU” Protocol 13. Total Coliforms NMT 10 cfu/gm “ASU” Protocol

STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: 2 years from the date of manufactured, if store under recommended conditions. WARNING: Once the package is opened it should be used at same time or it should be sealed immediately. Analysed By Approved By

23

PRODUCT SPECIFICATION

1. Name of the Product : Aloe indica, Aloevera Soft Extract- EC GRADE 2. Strength : 2:1 3. Batch Number : KH/AI/S// 4. Mfg. Date : 5. Date of Analysis : 6. Part of the Plant Used : Leaves

Sr. No.

Test Results Standards Test Method/Reference

A Physico chemical Tests 1. Description Brown colored thick

paste with Characteristic odour & taste.

Visual, ASU protocol

2. Identification Test – by TLC

Positive IP-2007

3. Water Soluble Extractive as per IP’66

NLT-80% IP-2007

4. Alcohol Soluble Extractive as per IP’66

--------- IP-2007

5. Moisture Content

NMT 30% IP-2007

6. pH (1% w/v aqueous solution)

3-7 IP-2007

B Active Ingredient 7.

Aloin((By spectrophotometer

method) Present Quality standard of

Indian Medicinal Plant

D Microbiological Tests

8 Total Aerobic Bacteria NMT 1000 cfu/gm “ASU” Protocol 9. Yeast and Moulds NMT 100 cfu/gm “ASU” Protocol

10. Total Coliforms NMT 10 cfu/gm “ASU” Protocol STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: 2 years from the date of manufactured, if store under recommended conditions. WARNING: Once the package is opened it should be used at same time or it should be sealed immediately. Analysed By Approved By

24

PRODUCT SPECIFICATION

Product Name Aloevera Oil Soluble – PREMIUM Botanical Name Aloe indica Part Used Leaves Ratio 3:1 Batch No. KH/AI/OS// Manufacturing Date Date of release

TEST RESULT METHOD STANDARD REFERENCE

A)PHYSICAL ANALYSIS 1.Appearance Visual Transparent Liquid “ASU” Protocol 2.Color Visual Light yellow to

light brown “ASU” Protocol

3.Odour Organoleptic Characteristic “ASU” Protocol 4.Viscosity Viscometer ----- “ASU” Protocol, I.P - 2007 B)PHYSICOCHEMICAL ANALYSIS 5.Specific Gravity ( 20°C) Gravimetric 0.70 – 0.90 “ASU” Protocol, I.P - 2007 6.Refractive Index By Refractometer 1.431 – 1.489 “ASU” Protocol, I.P - 2007 7.Saponification Value Volumetric NMT 0.1 “ASU” Protocol, I.P - 2007 8.Iodine Value Volumetric NMT 1% “ASU” Protocol, I.P - 2007 9..Moisture Content Gravimetric NMT 0.1 % “ASU” Protocol, I.P - 2007 10.Acid Value Volumetric NMT 1 “ASU” Protocol, I.P - 2007 11.Rancidity test Kries Test Not Rancid “ASU” Protocol, I.P - 2007 12.Peroxide Value Volumetric NMT 0.1 “ASU” Protocol, I.P - 2007 C)HEAVY METAL ANALYSIS 13.Arsenic By AAS NMT 3 ppm BP 2007,”ASU” Protocol 14.Lead By AAS NMT 10 ppm BP 2007,”ASU” Protocol 15.Mercury By AAS NMT 1 ppm BP 2007,”ASU” Protocol 16.Cadmium By AAS NMT 0.3 ppm BP 2007,”ASU” Protocol D)MICROBIOLOGICAL PROFILE 17.Total Plate Count Pour Plate Method NMT 500cfu/gm USP (61)(62),“ASU” Protocol 18.Yeast & Mould Pour Plate Method NMT 102 cfu/gm USP (61)(62) “ASU” Protocol 19.Salmonella sp. Identification

Method NMT Absent USP (61)(62),“ASU” Protocol

20.Escherichia. Coli Identification Method

NMT Absent USP (61)(62),“ASU” Protocol

21.Pseudomonas aeroginosa

Identification Method

NMT Absent USP (61)(62),“ASU” Protocol

Staphylococcus aureus Identification Method

NMT Absent USP (61)(62),“ASU” Protocol

22.Total Coliforms Pour Plate Method NMT 10 cfu/gm USP (61)(62),“ASU” Protocol STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: One year. For use after Prescribed, re-test. OPINION OF ANALYST: The above material complies with the prescribed standards. Analyzed By Approved By

25

PRODUCT SPECIFICATION

Product Name Aloevera Oil Soluble – STANDARD Botanical Name Aloe indica Part Used Leaves Ratio 2:1 Batch No. KH/AI/OS// Manufacturing Date Date of release

TEST RESULT METHOD STANDARD REFERENCE

A)PHYSICAL ANALYSIS 1.Appearance Visual Transparent Liquid “ASU” Protocol 2.Color Visual Light yellow to

light brown “ASU” Protocol

3.Odour Organoleptic Characteristic “ASU” Protocol 4.Viscosity Viscometer ----- “ASU” Protocol, I.P – 2007 B)PHYSICOCHEMICAL ANALYSIS 5.Specific Gravity ( 20°C) Gravimetric 0.70 – 0.90 “ASU” Protocol, I.P – 2007 6.Refractive Index By Refractometer 1.431 – 1.489 “ASU” Protocol, I.P – 2007 7.Saponification Value Volumetric NMT 0.1 “ASU” Protocol, I.P – 2007 8.Iodine Value Volumetric NMT 1% “ASU” Protocol, I.P – 2007 9..Moisture Content Gravimetric NMT 0.1 % “ASU” Protocol, I.P – 2007 10.Acid Value Volumetric NMT 1 “ASU” Protocol, I.P – 2007 C)HEAVY METAL ANALYSIS 11.Arsenic By AAS NMT 3 ppm BP 2007,”ASU” Protocol 12.Lead By AAS NMT 10 ppm BP 2007,”ASU” Protocol D)MICROBIOLOGICAL PROFILE 13.Total Plate Count Pour Plate Method NMT 103 cfu/gm USP (61)(62),“ASU” Protocol 14.Yeast & Mould Pour Plate Method NMT 102 cfu/gm USP (61)(62) “ASU” Protocol 15.Total Coliforms Pour Plate Method NMT 10 cfu/gm USP (61)(62),“ASU” Protocol

STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: One year. For use after Prescribed, re-test. OPINION OF ANALYST: The above material complies with the prescribed standards. Analyzed By Approved By

26

PRODUCT SPECIFICATION

Product Name Aloevera Oil Soluble – EC GRADE Botanical Name Aloe indica Part Used Leaves Ratio 1:1 Batch No. KH/AI/OS// Manufacturing Date Date of release

TEST RESULT METHOD STANDARD REFERENCE

A)PHYSICAL ANALYSIS 1.Appearance Visual Transparent Liquid “ASU” Protocol 2.Color Visual Light yellow to

light brown “ASU” Protocol

3.Odour Organoleptic Characteristic “ASU” Protocol 4.Viscosity Viscometer ----- “ASU” Protocol, I.P - 2007 B)PHYSICOCHEMICAL ANALYSIS 5.Specific Gravity ( 20°C) Gravimetric 0.70 – 0.90 “ASU” Protocol, I.P - 2007 6.Refractive Index By Refractometer 1.431 – 1.489 “ASU” Protocol, I.P - 2007 7..Moisture Content Gravimetric NMT 0.1 % “ASU” Protocol, I.P - 2007 D)MICROBIOLOGICAL PROFILE 8.Total Plate Count Pour Plate Method NMT 103 cfu/gm USP (61)(62),“ASU” Protocol 9.Yeast & Mould Pour Plate Method NMT 102 cfu/gm USP (61)(62) “ASU” Protocol 10.Total Coliforms Pour Plate Method NMT 10 cfu/gm USP (61)(62),“ASU” Protocol

STORAGE: Store in air tight containers at around 25°C away from direct moisture, heat & light. SELF LIFE: One year. For use after Prescribed, re-test. OPINION OF ANALYST: The above material complies with the prescribed standards. Analyzed By Approved By