BIOASSAY Basic Information NEW 2010
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Transcript of BIOASSAY Basic Information NEW 2010
BIO ASSAY BASIC INFORNATION
Sl. Reference Antiobiotic Initial Final Final Stock Median Use Medium Test Incubation Limit of
No Name Solvent DiluentConcentration/ml Dose Within & Final pH Organism Temperature Potency
1 Bacitracin zinc (CP) 0.01N HCl Buffer (B.1) 100 U 14 Days M.1 (pH 6.6) Micrococcus lutues 32 to 35 < 40 Units
Bacitracin zinc (CP) 0.01N HCl pH 7.0 (.05 M) Stock0.01N HCl N/A M.A (pH 7.0) Micrococcus lutues 35 to 39 < 40 Units
2 Erythromycin (CP) Methanol Buffer (B.3) 1 mg M.11 (pH 8.3) Micrococcus lutues 32 to 35 90% to 120%
Erythromycin Esto. (CP) Methanol pH 8.0 (.05 M) N/A N/A M.A (pH 7.9) Bacillus subtilis 30 to 37
Erythromycin St.CP) Methanol pH 8.0 (.05 M) N/A N/A M.A (pH 7.9) Bacillus subtilis 30 to 37
Erythromycin Suc.(T) Water N/A N/A M.C (pH 7.0) Staph. aureus 35 to 37
3 Gentamycin (CP) Buffer (B.3) Buffer (B.3) 1 mg 30 Days M.11 (pH 8.3) Staph. epidermidis 32 to 35
Gentamycin Sulphate (CP) Water pH 8.0 (.05 M) N/A N/A M.A (pH 7.9) Staph. epidermidis 35 to 39
Gentamycin Sulphate (T) Water pH 7.0 N/A N/A M.C (pH 7.0) Staph. aureus 35 to 37
4 Gramicidine (T) 95% alcohol 95% alcohol 1 mg 30 Days M.3 (pH 7.0) Enterococcus hirae 36 to 37.5
Gramicidine (T) Methanol pH 7.0 N/A N/A M.C (pH 7.0) Enterococcus hirae 35 to 37
5 Neomycin (CP) Buffer (B.3) Buffer (B.3) 1 mg 14 Days M.11 (pH 8.3) Staph. epidermidis 32 to 35 600 µg/mg
Neomycin Sulphate (CP) Water pH 8.0 (.05 M) N/A N/A M.E (pH 7.9) Bacillus subtilis 30 to 37 680 IU/mg
Neomycin Sulphate (T) Water pH 8.0 N/A N/A M.C (pH 7.0) Staph. aureus 35 to 37 680 IU/mg
6 Nystatin (CP) Dimethyleformamide Buffer (B.6) 1000 U Some Day M.19 (pH 6.1) Saccha. cerevisiae 29 to 31
Nystatin (CP) Dimethyleformamide pH 6.0 (.05 M) N/A N/A M.F (pH 6.0) Saccha. cerevisiae 30 to 32
7 Streptomycin (T) Water Water 1 mg 30 Days M.3 (pH 7.0) Kleb. pneumoniae 36 to 37.5 650-850 µg/mg
Streptomycin sulphate (CP) Water pH 8.0 (.05 M) N/A N/A M.A (pH 7.9) Bacillus subtilis 30 to 37
Streptomycin sulphate (T) Water pH 8.0 N/A N/A M.C (pH 7.0) Kleb. pneumoniae 35 to 37
8 Tobramycin(T) Water Water 1 mg 14 Days M.3 (pH 7.0) Staph. aureus 32 to 35 90% to 120%
9 Vancomycin (CP) Water Buffer (B.4) 1 mg 7 Days M.8 (pH 5.9) Bacillus subtilis 32 to 35
Vancomycin HCl(CP) Water pH 8.0 N/A N/A M.A (pH 8.0) Bacillus subtilis 37 to 39
Vancomycin HCl(T) Water pH 8.0 N/A N/A M.C (pH 7.0) Staph. aureus 37 to 39
USP/Vol IV/2007/2517
BP/Vol 29/2006/A317
USP/Vol 29/2006/2517
BP/Vol IV/2007/A317
BP/Vol IV/2007/A317
BP/Vol 29/2006/A317 pH 8.0
USP/Vol 29/2006/2517 NLT 590µg/mg
BP/Vol IV/2007/A317
BP/Vol IV/2007/A317
USP/Vol 29/2006/2517 NLT 900µg/mg
BP/Vol IV/2007/A317
USP/Vol 29/2006/2517
BP/Vol IV/2007/A317
BP/Vol IV/2007/A317
USP/Vol 29/2006/2517 NLT 5000 IU/mg
BP/Vol IV/2007/A317
USP/Vol 29/2006/2517
BP/Vol IV/2007/A317
BP/Vol IV/2007/A317
USP/Vol 29/2006/2517
USP/Vol 29/2006/2517 NLT 950µg/mg
BP/Vol IV/2007/A317
BP/Vol IV/2007/A317
10 Paromomycin Buffer (B.3) Buffer (B.3) 1 mg 21 Days M.11 (pH 8.3) Staph. epidermidisUSP/Vol 29/2006/2517
INCEPTA PHARMACEUTICALS LTD
MICROBIOLOGY LABORATORY
Specification for micro biological Assay of AntibioticsRAW MATERIAL
SL NO Name of the material Specification
1 Neomycin Sulphate Not less than 680 IU/mg, calculated on dry basis
2 Gentamycin sulphate Not less than 590 IU/mg, calculated on dry basis
3 Bacitracin Zinc Not less than 40 IU/mg, calculated on dry basis
4 Erythromycin Ethyl succinate Not less than 780 IU/mg, calculated on dry basis
5 Tobramycin Not less than 900 mcg/mg, calculated on dry basis
6 Nystatin Micronized Not less than 4400 IU/mg, calculated on dry basis
7 Vancomycin for Inj Not less than 925 mcg/mg, calculated on dry basis
8 Teicoplanin Not less than 900 mcg/mg, calculated on dry basis
9 polymixin B Sulphate Not less than 6000 IU/mg, calculated on dry basis
10 Gramicidin Not less than 900 IU/mg, calculated on dry basis
11 Streptomycin Sulphate Not less than 700 IU/mg, calculated on dry basis
12 Tylocin Tertrate Not less than 800 IU/mg, calculated on dry basis
Specification for micro biological Assay of AntibioticsFINISHED PRODUCTS
SL NO Name of the material Specification
1 Ethamate- N eye drops(Neomycin) Neomycin content should be 4.5 to 6.0 mg.ml
2 Firmac oral suspention Erythromycin content should be 112.5 to 150mg/5ml
3 (Erythromycin ethyl succinate) Erythromycin content should be 90% to 120%(USP'27)
4 Firmac 250 mg Tablet Erythromycin content should be 225 to 300mg/tab
5 (Erythromycin Stearate) Erythromycin content should be 90% to 120%(USP'27)
6 Firmac 500 mg Tablet Erythromycin content should be 450 to 600mg/tab
7 (Erythromycin Stearate) Erythromycin content should be 90% to 120%(USP'27)
8 Nyclobate N-N-cream Neomycin Sulphate content should be 4.5 to 6.0mg/gm
9 (Neomycin sulphate & Nystatin) Nystatin content should be 90000 to 100000
10 Intobac eye drops Tobramycin content should be 2.7 to 3.6mg/ml
11 (Tobramycin)
12 DNP eye Drops Neomycin content should be 3.15 to 4.2mg/ml
13 (Neomycin & polymixin) Polymixin content should be 5400 to 7200 IU/ml
14 Vanmycin Inj 500 mg Vancomycin content should be 450 to 575 mcg/mg
15 (vancomycin HCl) Vancomycin content should be 90% to 115% (USP'07)
16 Vanmycin Inj 1 gm Vancomycin content should be 900 to 1150 mcg/mg
17 (vancomycin HCl) Vancomycin content should be 90% to 115% (USP'07)
18 Gentamycin Inj Not less than 90% to 125%, calculated on dry basis
19 Teicoplanin Inj Not less than 170 - 250 (85% to 125%), calculated on dry basis
MICROBIOLOGICAL ASSAY Document No. BA/Nyc/01/01 Date Effective : 13.09.09
Material/ Product NamNyclobate NN Cream (Nystatin) Stage: FinalStandard Name: Nystatin Active Name: NystatinStandard Referance: N/A CoA/ Label Clame 100000 IU/ gm creamStandard Source.: N/A Source: ProductionStandard Potency: 5800 IU/mg Specification: 90000-120000 IU/ gm cream
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Sacch. CerevisiaeTest Medium M-19 (pH: 6.1) Final Stock Conc. 1000 IUInitial Solvent DMF Stock Use Within Same DayFinal Diluent B-6; pH = 6.0 (0.05M) Median Dose
Test DiluationStandard Dilution: Sample Dilution:
2.0 gm Cream (eq. wt. of 100000 IU) ↓ (eq. wt. of 200000 IU) ↓
↓ 2 ml ↓ 10 ml ↓ ↓
↓ ↓ →→→→ 100 ml (20 IU) ↓ 10 ml
↓
↓ →→→→ 100 ml (20 IU)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
17.3 mg std →→ 10 ml DMF →→100 ml Buffer (1000 IU) →→ 100 ml DMF (2000 IU)
→→→→ 50 ml (40 IU) 100 ml (200 µg)
→→→→ 50 ml (40 IU)
MICROBIOLOGICAL ASSAY Document No. BA/DEX/01/01 Date Effective : 15.12.09
Material/ Product Name: Dextrobac eye drop Stage: FinalStandard Name: Tobramycin Active Name: TobramycinStandard Referance: 20060315 CoA/ Label Clame 3 mg Tobramycin/ mlStandard Source.: N/A Source: ProductionStandard Potency: 922 µg/mg Specification: 2.7 - 3.6 mg/ ml
Parmacopeial Information's: Referance : In House
Test Method Cylinder Plate (CP) Test Organism Staph. AureusTest Medium Tobramycin medium Final Stock Conc. N/AInitial Solvent Water Stock Use Within N/AFinal Diluent Water Median Dose N/A
Test DiluationStandard Diluation: Sample Diluation:
54.2 mg →→→ →→ 100 ml (500 µg) 3.5 ml →→→ →→ 100 ml (100 µg)(eq. wt. of 50,000 µg) ↓ (eq. wt. of 10,000 µg) ↓
↓ 1 ml ↓ 5 ml ↓ ↓ ↓→→ 50 ml (10µg) ↓→→ 50 ml (10µg) ↓ ↓ →→ → 100 ml (5 µg) →→ → 100 ml (5 µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
MICROBIOLOGICAL ASSAY Document No. BA/INT/01/01 Date Effective : 15.12.09
Material/ Product Name: Introbac eye drop Stage: FinalStandard Name: Tobramycin Active Name: TobramycinStandard Referance: 20060315 CoA/ Label Clame 3 mg Tobramycin/ mlStandard Source.: N/A Source: ProductionStandard Potency: 922 µg/mg Specification: 2.7 - 3.6 mg/ ml
Parmacopeial Information's: Referance : In House
Test Method Cylinder Plate (CP) Test Organism Staph. AureusTest Medium Tobramycin medium Final Stock Conc. N/AInitial Solvent Water Stock Use Within N/AFinal Diluent Water Median Dose N/A
Test DiluationStandard Diluation: Sample Diluation:
54.2 mg →→→ →→ 100 ml (500 µg) 3.5 ml →→→ →→ 100 ml (100 µg)(eq. wt. of 50,000 µg) ↓ (eq. wt. of 10,000 µg) ↓
↓ 1 ml ↓ 5 ml ↓ ↓ ↓→→ 50 ml (10µg) ↓→→ 50 ml (10µg) ↓ ↓ →→ → 100 ml (5 µg) →→ → 100 ml (5 µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
MICROBIOLOGICAL ASSAY Document No. BA/TOB/01/01
Material/ Product Name: Tobramycin RM Stage:Standard Name: Tobramycin Active Name:Standard Referance: 20060315 CoA/ Label ClameStandard Source.: N/A Source:Standard Potency: 922 µg/mg Specification:
Parmacopeial Information's: Referance :
Test Method Turbidemetric Method Test Organism Test Medium M-03 (pH: 7.0) Final Stock Conc.Initial Solvent Water Stock Use WithinFinal Diluent Water Median Dose
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 50,000 µg) ↓ (eq. wt. of 50,000 µg) ↓ 1 ml
↓
0 Checked By:
QC Officer, Microbiology Asst. Manager, QC
54.20 mg →→→ →→ 100 ml (500 µg) 54.20 mg →→→
→→→ 50 ml (10 µg)
→→ → 100 ml (5 µg)
Date Effective : 10.09.09
RAWTobramycinN/AN/A>900 µg/mg
In House
Staph. AureusN/AN/AN/A
↓ ↓ 1 ml
↓
→→ 100 ml (500 µg)
→→→ 50 ml (10 µg)
→→ → 100 ml (5 µg)
MICROBIOLOGICAL ASSAY Document No. BA/Neo/01/01 Date Effective : 13.09.09
Material/ Product Name: Neomycin RM Stage: RawStandard Name: Neomycin sulphate Active Name: Neomycin sulphateStandard Referance: 200906046 (R-836/09) CoA/ Label Clame N/AStandard Source.: N/A Source: N/AStandard Potency: 684 µg/mg Specification: NLT 680 µg/mg
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Test Medium M-11 (pH: 8.3) Final Stock Conc. 1 mg/ mlInitial Solvent Diethylether Stock Use Within 14 daysFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose 1.0 µg/ ml
Test DiluationStandard Diluation: Sample Diluation:
58.5 mg →→→ →→ 100 ml (400 µg) 58.5 mg →→→ →→ 100 ml (400 µg)(eq. wt. of 40,000 µg) ↓ (eq. wt. of 40,000 µg) ↓
↓ 10 ml 10 ml ↓ 10 ml 10 ml ↓ ↓ 50 ml (80µg) →→→ 50 ml (16µg) 50 ml (80µg) →→→ 50 ml (16µg) ↓ ↓ ↓ 10 ml ↓ 10 ml →→ → 50 ml (16 µg) →→ → 50 ml (16 µg) ↓ ↓ →→→ 100 ml (8µg) →→→ 100 ml (8µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
Staph. epidermidis (ATCC 12228)
MICROBIOLOGICAL ASSAY Document No. BA/Neo/01/01 Date Effective : 13.09.09
Material/ Product Name: Nebazine oinment (Neomycin) Stage: FinalStandard Name: Neomycin sulphate Active Name: Neomycin sulphate
Standard Referance: 200906046 (R-836/09) CoA/ Label ClameStandard Source.: N/A Source: ProductionStandard Potency: 684 µg/mg Specification: 4.5 - 6.0 mg/ gm cream
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Test Medium M-11 (pH: 8.3) Final Stock Conc. 1 mg/ mlInitial Solvent Diethylether Stock Use Within 14 daysFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose 1.0 µg/ ml
Test DiluationStandard Diluation: Sample Diluation:
58.5 mg →→→ →→ 100 ml (400 µg) 3 gm ointment →→ 100 ml (100 µg)(eq. wt. of 40,000 µg) ↓ (eq. wt. of 10,000 µg) ↓
↓ 10 ml 10 ml ↓ 8 ml ↓ →→→ 50 ml (16 µg) 50 ml (80µg) →→→ 50 ml (16µg) ↓ ↓ →→ →→ 100 ml (8µg) ↓ 10 ml →→ → 50 ml (16 µg) ↓ →→→ 100 ml (8µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
5 mg Neomycin SO4/ gm ointment
Staph. epidermidis (ATCC 12228)
MICROBIOLOGICAL ASSAY Document No. BA/Beta/01/01 Date Effective : 13.09.09
Material/ Product Name: Betamethasone oinment (Neomycin) Stage: FinalStandard Name: Neomycin sulphate Active Name: Neomycin sulphate
Standard Referance: 200906046 (R-836/09) CoA/ Label ClameStandard Source.: N/A Source: ProductionStandard Potency: 684 µg/mg Specification: 4.5 - 6.0 mg/ gm cream
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Test Medium M-11 (pH: 8.3) Final Stock Conc. 1 mg/ mlInitial Solvent Diethylether Stock Use Within 14 daysFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose 1.0 µg/ ml
Test DiluationStandard Diluation: Sample Diluation:
58.5 mg →→→ →→ 100 ml (400 µg) 3 gm ointment →→ 100 ml (100 µg)(eq. wt. of 40,000 µg) ↓ (eq. wt. of 10,000 µg) ↓
↓ 10 ml 10 ml ↓ 8 ml ↓ →→→ 50 ml (16 µg) 50 ml (80µg) →→→ 50 ml (16µg) ↓ ↓ →→ →→ 100 ml (8µg) ↓ 10 ml →→ → 50 ml (16 µg) ↓ →→→ 100 ml (8µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
5 mg Neomycin SO4/ gm ointment
Staph. epidermidis (ATCC 12228)
MICROBIOLOGICAL ASSAY Document No. BA/Nyc/01/01 Date Effective : 13.09.09
Material/ Product Name: Nyclobate NN Cream (Neomycin) Stage: FinalStandard Name: Neomycin sulphate Active Name: Neomycin sulphate
Standard Referance: 200906046 (R-836/09) CoA/ Label ClameStandard Source.: N/A Source: ProductionStandard Potency: 684 µg/mg Specification: 4.5 - 6.0 mg/ gm cream
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Test Medium M-11 (pH: 8.3) Final Stock Conc. 1 mg/ mlInitial Solvent B-3; pH = 8.0 (0.05M) Stock Use Within 14 daysFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose 1.0 µg/ ml
Test DiluationStandard Diluation: Sample Diluation:
58.5 mg →→→ →→ 100 ml (400 µg) 3 gm ointment →→ 100 ml (100 µg)(eq. wt. of 40,000 µg) ↓ (eq. wt. of 10,000 µg) ↓
↓ 10 ml 10 ml ↓ 8 ml ↓ →→→ 50 ml (16 µg) 50 ml (80µg) →→→ 50 ml (16µg) ↓ ↓ →→ →→ 100 ml (8µg) ↓ 10 ml →→ → 50 ml (16 µg) ↓ →→→ 100 ml (8µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
5 mg Neomycin SO4/ gm ointment
Staph. epidermidis (ATCC 12228)
MICROBIOLOGICAL ASSAY Document No. BA/Par/01/01
Material/ Product Name: Paromomycin 250 Capsule Stage:Standard Name: Paromomycin Sulphate Active Name:Standard Referance: WS-080803 CoA/ Label ClameStandard Source.: Zhejiang Pharma. Co. Ltd. China Source:Standard Potency: 735 µg/mg Specification:
Parmacopeial Information's: Referance :
Test Method Cylinder Plate (CP) Test Organism Test Medium M-11 (pH: 8.3) Final Stock Conc.Initial Solvent B-3; pH = 8.0 (0.05M) Stock Use WithinFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 50,000 µg) ↓ (eq. wt. of 50,000 µg) ↓ 1 ml
↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
68.0 mg →→→ →→ 100 ml (500 µg) 68.0 mg →→→
→→→ 50 ml (10 µg)
→→ → 100 ml (5 µg)
Date Effective : 10.09.09
FinalParomomycin SulphateN/AN/A 90-125%
USP 29 < 81> : 2007
1 mg/ ml21 days
1.0 µg/ ml
↓ ↓ 1 ml
↓
Staph. epidermidis (ATCC 12228)
→→ 100 ml (500 µg)
→→→ 50 ml (10 µg)
→→ → 100 ml (5 µg)
MICROBIOLOGICAL ASSAY Document No. BA/Par/02/01
Material/ Product Name: Paromomycin 250 Capsule Stage:Standard Name: Paromomycin Sulphate Active Name:Standard Referance: WS-080803 CoA/ Label ClameStandard Source.: Zhejiang Pharma. Co. Ltd. China Source:Standard Potency: 735 µg/mg Specification:
Parmacopeial Information's: Referance :
Test Method Cylinder Plate (CP) Test Organism Test Medium M-11 (pH: 8.3) Final Stock Conc.Initial Solvent B-3; pH = 8.0 (0.05M) Stock Use WithinFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 50,000 µg) ↓ (eq. wt. of 10,00,000 µg) ↓ 1 ml
↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
68.0 mg →→→ →→ 100 ml (500 µg) 4 Capsule →→
→→→ 50 ml (10 µg)
→→ → 100 ml (5 µg)
Date Effective : 10.09.09
FinalParomomycin Sulphate250 mg Paromomycin/ CapsuleN/A 225 - 312.5 mg/cap (90-125%)
USP 29 < 81> : 2007
1 mg/ ml21 days
1.0 µg/ ml
↓ 5 ml
↓ ↓ 1 ml
↓
Staph. epidermidis (ATCC 12228)
→→ 100 ml (10000 µg)
100 ml (500 µg)
→→→ 50 ml (10 µg)
→→ → 100 ml (5 µg)
MICROBIOLOGICAL ASSAY Document No. BA/Bac/01/01
Material/ Product Name: Bacitracin zinc Stage:Standard Name: Bacitracin zinc Active Name:Standard Referance: Bac/01/09 CoA/ Label ClameStandard Source.: Source:Standard Potency: 78 IU/mg Specification:
Lab Specification:
Parmacopeial Information's: Referance :
Test Method Cylinder Plate Test Organism Test Medium M-01 (pH: 6.6) Final Stock Conc.Initial Solvent 0.01 N HCl Stock Use WithinFinal Diluent B.1 Median Dose
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 1000 µg) ↓ (eq. wt. of 1000 µg) ↓ 1 ml
↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
13 mg →→→ →→ 10ml (0.01 N HCl) 13 mg →→→
→→→ 50 ml (1IU)
→→ → 100 ml (0.5 IU)
Date Effective : 08.11.09
RAWBacitracin zincN/AN/A>65 IU /mg USP & >60 IU/mg BP70 IU /mg Inhouse
USP 32 < 81> : 2009,
Micrococcus.luteus100 IUSame day
1 IU
↓ ↓ 1 ml
↓
→→ 10ml (0.01 N HCl)
→→→ 50 ml (1IU)
→→ → 100 ml (0.5 IU)
MICROBIOLOGICAL ASSAY Document No. BA/Bac/02/01 Date Effective : 08.11.09
Material/ Product Name: Nebazin Ointment(Bacitracin zinc) Stage: FinalStandard Name: Bacitracin zinc Active Name: Bacitracin zincStandard Referance: Bac/01/09 CoA/ Label Clame N/AStandard Source.: Source: N/AStandard Potency: 78 IU/mg Specification: 90% to 130%
Lab Specification: 500IU/mg
Parmacopeial Information's: Referance : USP /IV/2006/2517
Test Method Cylinder Plate Test Organism Micrococcus.luteusTest Medium M-01 (pH: 6.6) Final Stock Conc. 100 IUInitial Solvent 0.01 N HCl Stock Use Within Same dayFinal Diluent B.1 Median Dose 1 IU
Test DiluationStandard Diluation: Sample Diluation:
2.0 gms.# (1000 IU) (eq. wt. of 1000 µg) ↓ ↓
↓ 1 ml Dissolve in 50ml Di-ethyl Ether ↓ 10 ml4 Time Extraction each with ↓
↓25ml 20ml 0.01N HCl ↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
13 mg →→→ →→ 10ml (0.01 N HCl) →→ 100 ml 0.01N HCl(10 IU)
→→→ 100 ml (1IU) ↓ →→→ 100 ml (1 IU)
→→ → 50 ml (0.5 IU) ↓ →→ →→ 50 ml(0.5 IU)
MICROBIOLOGICAL ASSAY Date Effective : 18.11.09
Material/ Product Name: Amphotericin Stage: Raw MaterialStandard Name: Amphotericin B Active Name: Amphotericin BStandard Referance: A-6019 CoA/ Label Clame N/AStandard Source.: AsencePharma Pvt. Ltd Source: N/AStandard Potency: 959 µg/mg Specification: NLT 750 µg
Parmacopeial Information's: Referance : USP /IV/2006/2517
Test Method Cylinder Plate Test Organism Sacch. CerevisiaeTest Medium M-19 (pH: 6.1) Final Stock Conc. 1mgInitial Solvent Dimethyle Sulfoxide (DMS) Stock Use Within Same dayFinal Diluent B.10 Median Dose 1 µg
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 50000 µg) (500 µg) (eq. wt. of 50000 µg) (500 µg) ↓ 10 ml ↓ 10 ml ↓ ↓ 100 ml (50 µg) 100 ml (50 µg)
↓ ↓ ↓2 ml ↓2 ml
↓ ↓ ↓ ↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
Document No. BA/AMPO/01/01
52.13 mg →→→ 10ml (DMSO)→→100 ml 52.13 mg →→→ 10ml (DMSO)→→100 ml
50 ml (2 µg) 50 ml (2 µg)
100 ml (1 µg) 100 ml (1 µg)
MICROBIOLOGICAL ASSAY Document No. BA/Nyc/01/01 Date Effective : 13.09.09
Material/ Product NamNystatin Stage: RawStandard Name: Nystatin Active Name: NystatinStandard Referance: N/A CoA/ Label Clame 100000 IU/ gm creamStandard Source.: N/A Source: ProductionStandard Potency: 5800 IU/mg Specification: NLT 4400 IU/ gm
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Sacch. CerevisiaeTest Medium M-19 (pH: 6.1) Final Stock Conc. 1000 IUInitial Solvent DMF Stock Use Within Same DayFinal Diluent B-6; pH = 6.0 (0.05M) Median Dose
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 100000 IU) ↓ (eq. wt. of 100000 IU) ↓ ↓ 2 ml ↓ 2 ml ↓ ↓
↓ ↓ →→→→ 100 ml (20 IU) →→→→ 100 ml (20 IU)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
17.3 mg std →→ 10 ml DMF →→100 ml Buffer (1000 IU) 17.3 mg std →→ 10 ml DMF →→100 ml Buffer (1000 IU)
→→→→ 50 ml (40 IU) →→→→ 50 ml (40 IU)
MICROBIOLOGICAL ASSAY Document No. BA/Gen/01/01 Date Effective : 13.09.09
Material/ Product Name: Intamycin 80 inj Stage: FinalStandard Name: Gentamycin Sulphate Active Name: Gentamycin SulphateStandard Referance: N/A CoA/ Label Clame 40 mg/ml injStandard Source.: N/A Source: ProductionStandard Potency: 613.67 µg/mg Specification: 36-40 mg/ml
Parmacopeial Information's: Referance : BP IV < A317> : 2007
Test Method Cylinder Plate (CP) Test Organism Staph. epidermidisTest Medium M-A (pH: 7.9) Final Stock Conc. 1 mgInitial Solvent Water Stock Use Within 30 daysFinal Diluent pH = 8.0 (0.05M) Median Dose
Test Diluation
Standard Diluation: Sample Diluation:
41.0 mg std 2.5 ml(eq. wt. of 25000 µg) ↓ (eq. wt. of 100000 µg) ↓
↓ 100 µl ↓ 100 µl ↓ ↓
↓ ↓
Prepared By: Checked By:
QC Officer, Microbiology Deputy Manager, QC
→→ 25 ml (1000 µg) →→ 100 ml (1000 µg)
↓ →→→ 100 ml (1 µg) ↓ →→→ 100 ml (1 µg)
↓ →→ →→ 50 ml (2 µg) ↓ →→ →→ 50 ml (2 µg)
MICROBIOLOGICAL ASSAY Document No. BA/Nyc/01/01 Date Effective : 13.09.09
Material/ Product Name: Intamycin 20 inj Stage: FinalStandard Name: Gentamycin Active Name: GentamycinStandard Referance: N/A CoA/ Label Claim 20 mg/ml injStandard Source.: N/A Source: ProductionStandard Potency: 613.67 µg/mg Specification: 18-25 mg/ml
Parmacopeial Information's: Referance : BP IV < A317> : 2007
Test Method Cylinder Plate (CP) Test Organism Staph. EpidermidisTest Medium M-11 (pH: 8.3) Final Stock Conc. 1 mgInitial Solvent Water Stock Use Within 30 daysFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose
Test DiluationStandard Diluation: Sample Diluation:
41.0 mg std 5.0 ml(eq. wt. of 25000 µg) ↓ (eq. wt. of 25000 µg) ↓
↓ 100 µl ↓ 100 µl ↓ ↓
↓ ↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
→→ 25 ml (1000 µg) →→ 25 ml (1000 µg)
↓ →→→ 100 ml (1 µg) ↓ →→→ 100 ml (1 µg)
↓ →→ →→ 50 ml (2 µg) ↓ →→ →→ 50 ml (2 µg)
MICROBIOLOGICAL ASSAY Document No. BA/Nyc/01/01 Date Effective : 13.09.09
Material/ Product Name: Intamycin 80 inj Stage: RawStandard Name: Gentamycin Active Name: GentamycinStandard Referance: CoA/ Label Clame N/AStandard Source.: Source: N/AStandard Potency: 613.67 µg/mg Specification: NLT 590 µg/mg
Parmacopeial Information's: Referance : BP IV < A317> : 2007
Test Method Cylinder Plate (CP) Test Organism Staph. EpidermidisTest Medium M-11 (pH: 8.3) Final Stock Conc. 1 mgInitial Solvent Water Stock Use Within 30 daysFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose
Test DiluationStandard Diluation: Sample Diluation:
41.0 mg std 41.0 mg std(eq. wt. of 25000 µg) ↓ (eq. wt. of 25000 µg) ↓
↓ 100 µl ↓ 100 µl ↓ ↓
↓ ↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
→→ 25 ml (1000 µg) →→ 25 ml (1000 µg)
↓ →→→ 100 ml (1 µg) ↓ →→→ 100 ml (1 µg)
↓ →→ →→ 50 ml (2 µg) ↓ →→ →→ 50 ml (2 µg)
MICROBIOLOGICAL ASSAY Document No. Date Effective : 12.04.10
Material/ Product Name: Firmac Dry Syrup Stage: FinalStandard Name: Erythromycin ethyl succinate Active Name: Erythromycin ethyl succinateStandard Referance: N/A CoA/ Label Clame 125 mg/ 5mlStandard Source.: N/A Source: ProductionStandard Potency: 869 µg/mg Specification: 112.5 - 150 mg/ 5ml
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism B. subtilisTest Medium M-A (pH: 7.9) Final Stock Conc. N/AInitial Solvent Methanol Stock Use Within Same DayFinal Diluent B-3; pH = 8.0 (0.05M) Mediam Dose
Test DiluationStandard Diluation: Sample Diluation: 1 bott recons. With 60 ml Water
8 ml Susp (form 1 Bottle)
(eq. wt. of 20000 µg) ↓ (200000 µg) ↓ 20 ml ↓ 1 ml ↓ ↓
↓ 1 ml ↓ ↓ →→→→ 100 ml (2µg)
↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
23.0 mg std →→ 10 ml Methanol →→100 ml Buffer (1000 IU) →→200 ml Methanol (1000 µg)
100 ml Buffer ( 200 µg) →→→→ 50 ml (4 µg)
→→→→ 50 ml (4 µg)
→→→→ 100 ml (2 µg)
MICROBIOLOGICAL ASSAY Document No. BA/VAN/01/01 Date Effective : 04.01.09
Material/ Product Name: Vanmycin 1 gm Injection Stage: FinalStandard Name: Vancomycin HCl Active Name: Vancomycin HClStandard Referance: MB/Vanco-01/08 CoA/ Label Clame 1000 mg/ vialStandard Source.: N/A Source: ProductionStandard Potency: 1010.03 µg/mg Specification: 900 to 1150 mg/ vial
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Bacillus subtilisTest Medium M.8(pH:)5.9 Final Stock Conc. 1 mgInitial Solvent Water Stock Use Within 7 daysFinal Diluent B4 pH:4.5 (0.05M) Median Dose 10 µg
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 52000 µg) ↓ (eq. wt. of 1000000µg) ↓ ↓ 5 ml ↓ 1 ml ↓ 2 ml ↓ 1 ml
↓ 2 ml ↓ 1 ml →→→→ 100 ml (10 µg) →→→→ 100 ml (10µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
51.5 mg std →→ 10 ml Buffer (5200 µg) 1000 mg vial → →→ 10 ml water (100000µg)
50 ml (500 µg)→→→→ 50 ml (20 µg) 100 (1000µg) →→→→ 50 ml (20µg)
MICROBIOLOGICAL ASSAY Document No. BA/VAN/02/01 Date Effective : 04.01.09
Material/ Product Name: Vanmycin 500 mg Injection Stage: FinalStandard Name: Vancomycin HCl Active Name: Vancomycin HClStandard Referance: MB/Vanco-01/08 CoA/ Label Clame 500 mg/ vialStandard Source.: N/A Source: ProductionStandard Potency: 1010.03 µg/mg Specification: 450 to 575 mg/ vial
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Bacillus subtilisTest Medium M.8(pH:)5.9 Final Stock Conc. 1 mgInitial Solvent Water Stock Use Within 7 daysFinal Diluent B4 pH:4.5 (0.05M) Median Dose 10 µg
Test DiluationStandard Dilution: Sample Dilution:
(eq. wt. of 52000 µg) ↓ (eq. wt. of 500000µg) ↓ ↓ 5 ml ↓ 1 ml ↓ 2 ml ↓ 2 ml
↓ 2 ml ↓ 2 ml →→→→ 100 ml (10 µg) →→→→ 100 ml (10µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
51.5 mg std →→ 10 ml Water (5200 µg) 500 mg vial → →→ 10 ml water (50000µg)
50 ml (500 µg)→→→→ 50 ml (20 µg) 100 (500µg) →→→→ 50 ml (20µg)
MICROBIOLOGICAL ASSAY Document No. BA/VAN/02/01 Date Effective : 04.01.09
Material/ Product Name: Vancomycin HCl Raw material Stage: FinalStandard Name: Vancomycin HCl Active Name: Vancomycin HClStandard Referance: MB/Vanco-01/08 CoA/ Label Clame N/AStandard Source.: N/A Source: N/AStandard Potency: 1010.03 µg/mg Specification: Not less than 900 µg mg
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Bacillus subtilisTest Medium M.8(pH:)5.9 Final Stock Conc. 1 mgInitial Solvent Water Stock Use Within 7 daysFinal Diluent B4 pH:4.5 (0.05M) Median Dose 10 µg
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 52000 µg) ↓ (eq. wt. ↓ ↓ 5 ml ↓ 5 ml ↓ 2 ml ↓ 2 ml
↓ 2 ml ↓ 2 ml →→→→ 100 ml (10 µg) →→→→ 100 ml (10 µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
51.5 mg std →→ 10 ml Buffer (5200 µg) 51.5 mg std →→ 10 ml Buffer (5200 µg)
50 ml (500 µg)→→→→ 50 ml (20 µg) 50 ml (500 µg)→→→→ 50 ml (20 µg)
MICROBIOLOGICAL ASSAY Document No. BA/CNeo/01/01 Date Effective : 10.05.10
Material/ Product Name: CORTAN PLUS EYE SUSPENTION Stage: FinalStandard Name: Neomycin sulphate Active Name: Neomycin sulphateStandard Referance: 200906046 CoA/ Label Clame 90% to 130%Standard Source.: R-836/09 Source: R & DFStandard Potency: 684 µg/mg Specification: 3.5 mg Neomycin SO4/ ml suspention
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Test Medium M-11 (pH: 8.3) Final Stock Conc. 1 mg/ mlInitial Solvent Diethylether Stock Use Within 14 daysFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose 1.0 µg/ ml
Test DiluationStandard Diluation: Sample Diluation:
29.25 mg →→→ →→ 100 ml (200 µg) 4.17 ml Eye suspention →→ 100 ml (100 µg)(eq. wt. of 20000 µg) ↓ (eq. wt. of 10,000 µg) ↓ 2 ml
↓ 1 ml →→→ 50 ml ( 4 µg) →→→ 50 ml (4 µg) ↓ 2 ml
↓ →→ →100 ml ( 2 µg) →→ → 100 ml ( 2 µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
USP 29
Staph. epidermidis (ATCC 12228)
↓ 1 ml
Assay— Proceed with Capsules as directed under Antibiotics—Microbial Assays
MICROBIOLOGICAL ASSAY Document No. BA/POL/01/01 Date Effective : 10.05.10
Material/ Product Name: CORTAN PLUS EYE SUSPENTION Stage: FinalStandard Name: Polymixin B Sulphate Active Name: Polymixin B SulphateStandard Referance: R & DF CoA/ Label Clame 90% to 130%Standard Source.: Source: R & DFStandard Potency: 7780 µg/mg Specification: 10000 units / ml suspention
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Bordelella bronchisepticaTest Medium M-11 (pH: 8.3) Final Stock Conc. 10000 UInitial Solvent Water, [ B6 ] Stock Use Within 14 daysFinal Diluent B-6; pH = 7.2 Median Dose 10 U/ml
Test DiluationStandard Diluation: Sample Diluation:
25.70 mg →→→ →→ 100 ml (2000 µg) 2 ml Eye suspention →→ 100 ml ( 200 µg)(eq. wt. of 200000 µg) ↓ (eq. wt. of 20,000 µg) ↓ 10 ml
↓ 1 ml →→→ 50 ml ( 40 µg) →→→ 50 ml (40 µg) ↓10 ml
↓ →→ →100 ml ( 20 µg) →→ → 100 ml ( 20 µg)
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
USP 29
↓ 1 ml
Assay— Proceed with Capsules as directed under Antibiotics—Microbial Assays
MICROBIOLOGICAL ASSAY Document No. BA/Prm/01/01 Date Effective : 10.09.09
Material/ Product Name: Paromomycin Sulphate Capsule Stage: PD TrialStandard Name: Paromomycin Sulphate Active Name: Paromomycin SulphateStandard Referance: WS-080803 CoA/ Label Clame 250 mg Paromomycin/ CapsuleStandard Source.: Zhejiang Pharma. Co. Ltd. China Source: R & DFStandard Potency: 735 µg/mg Specification: 225 - 312.5 mg/cap (90-125%)
Parmacopeial Information's: Referance : USP 29 < 81> : 2007
Test Method Cylinder Plate (CP) Test Organism Test Medium M-11 (pH: 8.3) Final Stock Conc. 1 mg/ mlInitial Solvent B-3; pH = 8.0 (0.05M) Stock Use Within 21 daysFinal Diluent B-3; pH = 8.0 (0.05M) Median Dose 1.0 µg/ ml
Test DiluationStandard Diluation: Sample Diluation:
(eq. wt. of 50,000 µg) ↓ (eq. wt. of 10,00,000 µg) ↓ 5 ml ↓ 1 ml
↓ ↓ ↓ 1 ml
↓
Prepared By: Checked By:
QC Officer, Microbiology Asst. Manager, QC
USP 29
81
Staph. epidermidis (ATCC 12228)
68.0 mg →→→ →→ 100 ml (500 µg) 4 Capsule →→ →→ 100 ml (10000 µg)
100 ml (500 µg) →→→ 50 ml (10 µg)
→→ → 100 ml (5 µg) →→→ 50 ml (10 µg)
→→ → 100 ml (5 µg)
Assay— Proceed with Capsules as directed under Antibiotics—Microbial Assays
, blending not less than 5 Capsules for 5 minutes in a high-speed blender with sufficient Buffer No. 3 to obtain a stock solution of convenient concentration. Dilute this stock solution quantitatively with the same buffer to obtain a Test Dilution having