BIO ASSAY BASIC INFORNATION

Sl. No
1 USP/Vol IV/2007/2517 BP/Vol 29/2006/A317

Reference

Antiobiotic Name
Bacitracin zinc (CP) Bacitracin zinc (CP)

Initial Solvent
0.01N HCl 0.01N HCl

Final
Buffer (B.1)

Final Stock
100 U

Median

Use Within
14 Days N/A

Medium & Final pH

Test Organism

Incubation Temperature
32 to 35 35 to 39

Limit of Potency
< 40 Units < 40 Units

Diluent Concentration/ml Dose

M.1 (pH 6.6) Micrococcus lutues M.A (pH 7.0) Micrococcus lutues

pH 7.0 (.05 M) Stock0.01N HCl

USP/Vol 29/2006/2517 BP/Vol IV/2007/A317 BP/Vol IV/2007/A317 BP/Vol 29/2006/A317

Erythromycin (CP) Erythromycin Esto. (CP) Erythromycin St.CP) Erythromycin Suc.(T)

Methanol Methanol Methanol Water

Buffer (B.3) pH 8.0 (.05 M) pH 8.0 (.05 M) pH 8.0

1 mg N/A N/A N/A N/A N/A N/A

M.11 (pH 8.3) Micrococcus lutues M.A (pH 7.9) Bacillus subtilis M.A (pH 7.9) Bacillus subtilis M.C (pH 7.0) Staph. aureus

32 to 35 30 to 37 30 to 37 35 to 37

90% to 120%

USP/Vol 29/2006/2517 BP/Vol IV/2007/A317 BP/Vol IV/2007/A317

Gentamycin (CP) Gentamycin Sulphate (CP) Gentamycin Sulphate (T)

Buffer (B.3) Water Water

Buffer (B.3) pH 8.0 (.05 M) pH 7.0

1 mg N/A N/A

30 Days N/A N/A

M.11 (pH 8.3) Staph. epidermidis M.A (pH 7.9) M.C (pH 7.0) Staph. epidermidis Staph. aureus

32 to 35 35 to 39 35 to 37

NLT 590g/mg

USP/Vol 29/2006/2517 BP/Vol IV/2007/A317

Gramicidine (T) Gramicidine (T)

95% alcohol Methanol

95% alcohol pH 7.0

1 mg N/A

30 Days N/A

M.3 (pH 7.0) Enterococcus hirae M.C (pH 7.0) Enterococcus hirae

36 to 37.5 35 to 37

NLT 900g/mg

USP/Vol 29/2006/2517 BP/Vol IV/2007/A317 BP/Vol IV/2007/A317

Neomycin (CP) Neomycin Sulphate (CP) Neomycin Sulphate (T)

Buffer (B.3) Water Water

Buffer (B.3) pH 8.0 (.05 M) pH 8.0

1 mg N/A N/A

14 Days N/A N/A

M.11 (pH 8.3) Staph. epidermidis M.E (pH 7.9) Bacillus subtilis M.C (pH 7.0) Staph. aureus

32 to 35 30 to 37 35 to 37

600 g/mg 680 IU/mg 680 IU/mg

USP/Vol 29/2006/2517 BP/Vol IV/2007/A317

Nystatin (CP) Nystatin (CP)

Dimethyleformamide

Buffer (B.6)

1000 U N/A

Some Day N/A

M.19 (pH 6.1) Saccha. cerevisiae M.F (pH 6.0) Saccha. cerevisiae

29 to 31 30 to 32

NLT 5000 IU/mg

Dimethyleformamide pH 6.0 (.05 M)

USP/Vol 29/2006/2517 BP/Vol IV/2007/A317 BP/Vol IV/2007/A317

Streptomycin (T) Streptomycin sulphate (CP) Streptomycin sulphate (T)

Water Water Water

Water pH 8.0 (.05 M) pH 8.0

1 mg N/A N/A

30 Days N/A N/A

M.3 (pH 7.0) Kleb. pneumoniae M.A (pH 7.9) Bacillus subtilis M.C (pH 7.0) Kleb. pneumoniae

36 to 37.5 30 to 37 35 to 37

650-850 g/mg

USP/Vol 29/2006/2517

Tobramycin(T)

Water

Water

1 mg

14 Days

M.3 (pH 7.0) Staph. aureus

32 to 35

90% to 120%

USP/Vol 29/2006/2517 BP/Vol IV/2007/A317 BP/Vol IV/2007/A317

Vancomycin (CP) Vancomycin HCl(CP) Vancomycin HCl(T)

Water Water Water

Buffer (B.4) pH 8.0 pH 8.0

1 mg N/A N/A

7 Days N/A N/A

M.8 (pH 5.9) Bacillus subtilis M.A (pH 8.0) Bacillus subtilis M.C (pH 7.0) Staph. aureus

32 to 35 37 to 39 37 to 39

NLT 950g/mg

10

USP/Vol 29/2006/2517

Paromomycin

Buffer (B.3)

Buffer (B.3)

1 mg

21 Days

M.11 (pH 8.3) Staph. epidermidis

INCEPTA PHARMACEUTICALS LTD

MICROBIOLOGY LABORATORY Specification for micro biological Assay of Antibiotics RAW MATERIAL
SL NO 1 2 3 4 5 6 7 8 9 10 11 12 Name of the material Neomycin Sulphate Gentamycin sulphate Bacitracin Zinc Erythromycin Ethyl succinate Tobramycin Nystatin Micronized Vancomycin for Inj Teicoplanin polymixin B Sulphate Gramicidin Streptomycin Sulphate Tylocin Tertrate Specification Not less than 680 IU/mg, calculated on dry basis Not less than 590 IU/mg, calculated on dry basis Not less than 40 IU/mg, calculated on dry basis Not less than 780 IU/mg, calculated on dry basis Not less than 900 mcg/mg, calculated on dry basis Not less than 4400 IU/mg, calculated on dry basis Not less than 925 mcg/mg, calculated on dry basis Not less than 900 mcg/mg, calculated on dry basis Not less than 6000 IU/mg, calculated on dry basis Not less than 900 IU/mg, calculated on dry basis Not less than 700 IU/mg, calculated on dry basis Not less than 800 IU/mg, calculated on dry basis

Specification for micro biological Assay of Antibiotics FINISHED PRODUCTS

SL NO 1 2 3 4 5 6 7 8 Name of the material Ethamate- N eye drops(Neomycin) Firmac oral suspention (Erythromycin ethyl succinate) Firmac 250 mg Tablet (Erythromycin Stearate) Firmac 500 mg Tablet (Erythromycin Stearate) Nyclobate N-N-cream Specification Neomycin content should be 4.5 to 6.0 mg.ml Erythromycin content should be 112.5 to 150mg/5ml Erythromycin content should be 90% to 120%(USP'27) Erythromycin content should be 225 to 300mg/tab Erythromycin content should be 90% to 120%(USP'27) Erythromycin content should be 450 to 600mg/tab Erythromycin content should be 90% to 120%(USP'27)
Neomycin Sulphate content should be 4.5 to 6.0mg/gm

9 10 11 12 13 14 15 16 17 18 19

(Neomycin sulphate & Nystatin) Intobac eye drops (Tobramycin) DNP eye Drops (Neomycin & polymixin) Vanmycin Inj 500 mg (vancomycin HCl) Vanmycin Inj 1 gm (vancomycin HCl) Gentamycin Inj Teicoplanin Inj

Nystatin content should be 90000 to 100000 Tobramycin content should be 2.7 to 3.6mg/ml

Neomycin content should be 3.15 to 4.2mg/ml Polymixin content should be 5400 to 7200 IU/ml Vancomycin content should be 450 to 575 mcg/mg Vancomycin content should be 90% to 115% (USP'07) Vancomycin content should be 900 to 1150 mcg/mg Vancomycin content should be 90% to 115% (USP'07) Not less than 90% to 125%, calculated on dry basis
Not less than 170 - 250 (85% to 125%), calculated on dry basis

MICROBIOLOGICAL ASSAY
Material/ Product Name: NN Cream (Nystatin) Nyclobate
Standard Name: Standard Referance: Standard Source.: Standard Potency: Nystatin N/A N/A 5800 IU/mg

Document No. BA/Nyc/01/01

Date Effective : 13.09.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Nystatin 100000 IU/ gm cream Production 90000-120000 IU/ gm cream

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-19 (pH: 6.1) DMF B-6; pH = 6.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Sacch. Cerevisiae 1000 IU Same Day

Test Diluation Standard Dilution: 17.3 mg std 10 ml DMF 100 ml Buffer (1000 IU) (eq. wt. of 100000 IU) 2 ml 50 ml (40 IU) 100 ml (20 IU)

Sample Dilution: 2.0 gm Cream 100 ml DMF (2000 IU) (eq. wt. of 200000 IU) 10 ml 100 ml (200 g) 10 ml 50 ml (40 IU) 100 ml (20 IU)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Dextrobac eye drop
Standard Name: Standard Referance: Standard Source.: Standard Potency: Tobramycin 20060315 N/A 922 g/mg

Document No. BA/DEX/01/01

Date Effective : 15.12.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Tobramycin 3 mg Tobramycin/ ml Production 2.7 - 3.6 mg/ ml

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) Tobramycin medium Water Water

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

In House Staph. Aureus N/A N/A N/A

Test Diluation Standard Diluation: 54.2 mg 100 ml (500 g) (eq. wt. of 50,000 g) 1 ml 50 ml (10g) 100 ml (5 g)

Sample Diluation: 3.5 ml 100 ml (100 g) (eq. wt. of 10,000 g) 5 ml 50 ml (10g) 100 ml (5 g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Introbac eye drop
Standard Name: Standard Referance: Standard Source.: Standard Potency: Tobramycin 20060315 N/A 922 g/mg

Document No. BA/INT/01/01

Date Effective : 15.12.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Tobramycin 3 mg Tobramycin/ ml Production 2.7 - 3.6 mg/ ml

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) Tobramycin medium Water Water

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

In House Staph. Aureus N/A N/A N/A

Test Diluation Standard Diluation: 54.2 mg 100 ml (500 g) (eq. wt. of 50,000 g) 1 ml 50 ml (10g) 100 ml (5 g)

Sample Diluation: 3.5 ml 100 ml (100 g) (eq. wt. of 10,000 g) 5 ml 50 ml (10g) 100 ml (5 g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Tobramycin RM
Standard Name: Standard Referance: Standard Source.: Standard Potency: Tobramycin 20060315 N/A 922 g/mg

Document No. BA/TOB/01/01

Stage: Active Name: CoA/ Label Clame Source: Specification:

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Turbidemetric Method M-03 (pH: 7.0) Water Water

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

Test Diluation Standard Diluation: 54.20 mg 100 ml (500 g) (eq. wt. of 50,000 g) 1 ml 50 ml (10 g) 100 ml (5 g)

Sample Diluation: 54.20 mg (eq. wt. of 50,000 g)

0 QC Officer, Microbiology

Checked By: Asst. Manager, QC

Date Effective : 10.09.09

RAW Tobramycin N/A N/A >900 g/mg

In House Staph. Aureus N/A N/A N/A

100 ml (500 g) 1 ml 50 ml (10 g) 100 ml (5 g)

MICROBIOLOGICAL ASSAY
Material/ Product Name: Neomycin RM
Standard Name: Standard Referance: Standard Source.: Standard Potency: Neomycin sulphate 200906046 (R-836/09) N/A 684 g/mg

Document No. BA/Neo/01/01

Date Effective : 13.09.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Raw Neomycin sulphate N/A N/A NLT 680 g/mg

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) Diethylether B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Staph. epidermidis (ATCC 12228) 1 mg/ ml 14 days 1.0 g/ ml

Test Diluation Standard Diluation: 58.5 mg 100 ml (400 g) (eq. wt. of 40,000 g) 10 ml 10 ml 50 ml (80g) 50 ml (16g) 10 ml 50 ml (16 g) 100 ml (8g)

Sample Diluation: 58.5 mg 100 ml (400 g) (eq. wt. of 40,000 g) 10 ml 10 ml 50 ml (80g) 50 ml (16g) 10 ml 50 ml (16 g) 100 ml (8g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Nebazine oinment (Neomycin)
Standard Name: Standard Referance: Standard Source.: Standard Potency: Neomycin sulphate 200906046 (R-836/09) N/A 684 g/mg

Document No. BA/Neo/01/01

Date Effective : 13.09.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Neomycin sulphate 5 mg Neomycin SO4/ gm ointment Production 4.5 - 6.0 mg/ gm cream

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) Diethylether B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Staph. epidermidis (ATCC 12228) 1 mg/ ml 14 days 1.0 g/ ml

Test Diluation Standard Diluation: 58.5 mg 100 ml (400 g) (eq. wt. of 40,000 g) 10 ml 10 ml 50 ml (80g) 50 ml (16g) 10 ml 50 ml (16 g) 100 ml (8g)

Sample Diluation: 3 gm ointment 100 ml (100 g) (eq. wt. of 10,000 g) 8 ml 50 ml (16 g) 100 ml (8g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Standard Name: Standard Referance: Standard Source.: Standard Potency: Neomycin sulphate 200906046 (R-836/09) N/A 684 g/mg

Document No. BA/Beta/01/01

Date Effective : 13.09.09

Material/ Product Name: Betamethasone oinment (Neomycin) Stage:

Active Name: CoA/ Label Clame Source: Specification:

Final Neomycin sulphate 5 mg Neomycin SO4/ gm ointment Production 4.5 - 6.0 mg/ gm cream

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) Diethylether B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Staph. epidermidis (ATCC 12228) 1 mg/ ml 14 days 1.0 g/ ml

Test Diluation Standard Diluation: 58.5 mg 100 ml (400 g) (eq. wt. of 40,000 g) 10 ml 10 ml 50 ml (80g) 50 ml (16g) 10 ml 50 ml (16 g) 100 ml (8g)

Sample Diluation: 3 gm ointment 100 ml (100 g) (eq. wt. of 10,000 g) 8 ml 50 ml (16 g) 100 ml (8g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Nyclobate NN Cream (Neomycin)
Standard Name: Standard Referance: Standard Source.: Standard Potency: Neomycin sulphate 200906046 (R-836/09) N/A 684 g/mg

Document No. BA/Nyc/01/01

Date Effective : 13.09.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Neomycin sulphate 5 mg Neomycin SO4/ gm ointment Production 4.5 - 6.0 mg/ gm cream

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) B-3; pH = 8.0 (0.05M) B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Staph. epidermidis (ATCC 12228) 1 mg/ ml 14 days 1.0 g/ ml

Test Diluation Standard Diluation: 58.5 mg 100 ml (400 g) (eq. wt. of 40,000 g) 10 ml 10 ml 50 ml (80g) 50 ml (16g) 10 ml 50 ml (16 g) 100 ml (8g)

Sample Diluation: 3 gm ointment 100 ml (100 g) (eq. wt. of 10,000 g) 8 ml 50 ml (16 g) 100 ml (8g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Paromomycin 250 Capsule
Standard Name: Standard Referance: Standard Source.: Standard Potency: Paromomycin Sulphate WS-080803 Zhejiang Pharma. Co. Ltd. China 735 g/mg

Document No. BA/Par/01/01

Stage: Active Name: CoA/ Label Clame Source: Specification:

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) B-3; pH = 8.0 (0.05M) B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

Test Diluation Standard Diluation: 68.0 mg 100 ml (500 g) (eq. wt. of 50,000 g) 1 ml 50 ml (10 g) 100 ml (5 g)

Sample Diluation: 68.0 mg (eq. wt. of 50,000 g)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

Date Effective : 10.09.09

Final Paromomycin Sulphate N/A N/A 90-125%

USP 29 < 81> : 2007 Staph. epidermidis (ATCC 12228) 1 mg/ ml 21 days 1.0 g/ ml

100 ml (500 g) 1 ml 50 ml (10 g) 100 ml (5 g)

MICROBIOLOGICAL ASSAY
Material/ Product Name: Paromomycin 250 Capsule
Standard Name: Standard Referance: Standard Source.: Standard Potency: Paromomycin Sulphate WS-080803 Zhejiang Pharma. Co. Ltd. China 735 g/mg

Document No. BA/Par/02/01

Stage: Active Name: CoA/ Label Clame Source: Specification:

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) B-3; pH = 8.0 (0.05M) B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

Test Diluation Standard Diluation: 68.0 mg 100 ml (500 g) (eq. wt. of 50,000 g) 1 ml 50 ml (10 g) 100 ml (5 g)

Sample Diluation: 4 Capsule (eq. wt. of 10,00,000 g)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

Date Effective : 10.09.09

Final Paromomycin Sulphate 250 mg Paromomycin/ Capsule N/A 225 - 312.5 mg/cap (90-125%)

USP 29 < 81> : 2007 Staph. epidermidis (ATCC 12228) 1 mg/ ml 21 days 1.0 g/ ml

100 ml (10000 g) 5 ml 100 ml (500 g) 1 ml 50 ml (10 g) 100 ml (5 g)

MICROBIOLOGICAL ASSAY
Material/ Product Name: Bacitracin zinc
Standard Name: Standard Referance: Standard Source.: Standard Potency: Bacitracin zinc Bac/01/09 78 IU/mg

Document No. BA/Bac/01/01

Stage: Active Name: CoA/ Label Clame Source: Specification: Lab Specification: Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate M-01 (pH: 6.6) 0.01 N HCl B.1

Test Diluation Standard Diluation: 13 mg 10ml (0.01 N HCl) (eq. wt. of 1000 g) 1 ml 50 ml (1IU) 100 ml (0.5 IU)

Sample Diluation: 13 mg (eq. wt. of 1000 g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

Date Effective : 08.11.09

RAW Bacitracin zinc N/A N/A >65 IU /mg USP & >60 IU/mg BP 70 IU /mg Inhouse USP 32 < 81> : 2009, Micrococcus.luteus 100 IU Same day 1 IU

10ml (0.01 N HCl) 1 ml 50 ml (1IU) 100 ml (0.5 IU)

MICROBIOLOGICAL ASSAY
Standard Name: Standard Referance: Standard Source.: Standard Potency: Bacitracin zinc Bac/01/09 78 IU/mg

Document No. BA/Bac/02/01

Date Effective : 08.11.09

Material/ Product Name: Nebazin Ointment(Bacitracin zinc) Stage:

Active Name: CoA/ Label Clame Source: Specification: Lab Specification: Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

Final Bacitracin zinc N/A N/A 90% to 130% 500IU/mg USP /IV/2006/2517 Micrococcus.luteus 100 IU Same day 1 IU

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate M-01 (pH: 6.6) 0.01 N HCl B.1

Test Diluation Standard Diluation: 13 mg 10ml (0.01 N HCl) (eq. wt. of 1000 g) 1 ml 100 ml (1IU) 25ml 50 ml (0.5 IU)

Sample Diluation: 2.0 gms.# (1000 IU) Dissolve in 50ml Di-ethyl Ether 4 Time Extraction each with 20ml 0.01N HCl

100 ml 0.01N HCl(10 IU) 10 ml 100 ml (1 IU) 50 ml(0.5 IU)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Amphotericin
Standard Name: Standard Referance: Standard Source.: Standard Potency: Amphotericin B A-6019 AsencePharma Pvt. Ltd 959 g/mg

Document No. BA/AMPO/01/01

Date Effective : 18.11.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Raw Material Amphotericin B N/A N/A NLT 750 g

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate M-19 (pH: 6.1) Dimethyle Sulfoxide (DMS) B.10

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP /IV/2006/2517 Sacch. Cerevisiae 1mg Same day 1 g

Test Diluation Standard Diluation: 52.13 mg 10ml (DMSO)100 ml (eq. wt. of 50000 g) (500 g) 10 ml
100 ml (50 g)

Sample Diluation: 52.13 mg 10ml (DMSO)100 ml (eq. wt. of 50000 g) (500 g) 10 ml

100 ml (50 g)

2 ml 50 ml (2 g) 100 ml (1 g)
Prepared By: Checked By:

2 ml 50 ml (2 g) 100 ml (1 g)

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Nystatin
Standard Name: Standard Referance: Standard Source.: Standard Potency: Nystatin N/A N/A 5800 IU/mg

Document No. BA/Nyc/01/01

Date Effective : 13.09.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Raw Nystatin 100000 IU/ gm cream Production NLT 4400 IU/ gm

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-19 (pH: 6.1) DMF B-6; pH = 6.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Sacch. Cerevisiae 1000 IU Same Day

Test Diluation Standard Diluation: 17.3 mg std 10 ml DMF 100 ml Buffer (1000 IU) (eq. wt. of 100000 IU) 2 ml 50 ml (40 IU) 100 ml (20 IU)

Sample Diluation: 17.3 mg std 10 ml DMF 100 ml Buffer (1000 IU) (eq. wt. of 100000 IU) 2 ml 50 ml (40 IU) 100 ml (20 IU)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Intamycin 80 inj
Standard Name: Standard Referance: Standard Source.: Standard Potency: Gentamycin Sulphate N/A N/A 613.67 g/mg

Document No. BA/Gen/01/01

Date Effective : 13.09.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Gentamycin Sulphate 40 mg/ml inj Production 36-40 mg/ml

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Test Diluation Cylinder Plate (CP) M-A (pH: 7.9) Water pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

BP IV < A317> : 2007 Staph. epidermidis 1 mg 30 days

Standard Diluation:
41.0 mg std 25 ml (1000 g) (eq. wt. of 25000 g) 100 l 100 ml (1 g) 50 ml (2 g)

Sample Diluation:
2.5 ml 100 ml (1000 g) (eq. wt. of 100000 g) 100 l 100 ml (1 g) 50 ml (2 g)

Prepared By:

Checked By:

QC Officer, Microbiology

Deputy Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Intamycin 20 inj
Standard Name: Standard Referance: Standard Source.: Standard Potency: Gentamycin N/A N/A 613.67 g/mg

Document No. BA/Nyc/01/01

Date Effective : 13.09.09

Stage: Active Name: CoA/ Label Claim Source: Specification:

Final Gentamycin 20 mg/ml inj Production 18-25 mg/ml

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) Water B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

BP IV < A317> : 2007 Staph. Epidermidis 1 mg 30 days

Test Diluation Standard Diluation: 41.0 mg std 25 ml (1000 g) (eq. wt. of 25000 g) 100 l 100 ml (1 g) 50 ml (2 g)

Sample Diluation: 5.0 ml 25 ml (1000 g) (eq. wt. of 25000 g) 100 l 100 ml (1 g) 50 ml (2 g)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Intamycin 80 inj
Standard Name: Standard Referance: Standard Source.: Standard Potency: Gentamycin

Document No. BA/Nyc/01/01

Date Effective : 13.09.09

613.67 g/mg

Stage: Active Name: CoA/ Label Clame Source: Specification:

Raw Gentamycin N/A N/A NLT 590 g/mg

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) Water B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

BP IV < A317> : 2007 Staph. Epidermidis 1 mg 30 days

Test Diluation Standard Diluation: 41.0 mg std 25 ml (1000 g) (eq. wt. of 25000 g) 100 l 100 ml (1 g) 50 ml (2 g)

Sample Diluation: 41.0 mg std 25 ml (1000 g) (eq. wt. of 25000 g) 100 l 100 ml (1 g) 50 ml (2 g)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Material/ Product Name: Dry Syrup Firmac
Standard Name: Standard Referance: Standard Source.: Standard Potency: Erythromycin ethyl succinate N/A N/A 869 g/mg

Document No.

Date Effective : 12.04.10

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Erythromycin ethyl succinate 125 mg/ 5ml Production 112.5 - 150 mg/ 5ml

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Test Diluation Standard Diluation: 23.0 mg std (eq. wt. of 20000 g) Cylinder Plate (CP) M-A (pH: 7.9) Methanol B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Mediam Dose

USP 29 < 81> : 2007 B. subtilis N/A Same Day

10 ml Methanol 100 ml Buffer (1000 IU) 1 ml 50 ml (4 g) 100 ml (2g)

Sample Diluation: 8 ml Susp (form 1 Bottle) (200000 g)

1 bott recons. With 60 ml Water 200 ml Methanol (1000 g) 20 ml 100 ml Buffer ( 200 g) 1 ml 50 ml (4 g) 100 ml (2 g)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY Material/ Product Name: Vanmycin 1 gm Injection

Standard Name: Standard Referance: Standard Source.: Standard Potency: Vancomycin HCl MB/Vanco-01/08 N/A 1010.03 g/mg

Document No. BA/VAN/01/01

Date Effective : 04.01.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Vancomycin HCl 1000 mg/ vial Production 900 to 1150 mg/ vial

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Test Diluation Standard Diluation: 51.5 mg std 10 ml Buffer (5200 g) (eq. wt. of 52000 g) 5 ml 2 ml 50 ml (500 g) 50 ml (20 g) 2 ml 100 ml (10 g) Cylinder Plate (CP) M.8(pH:)5.9 Water B4 pH:4.5 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Bacillus subtilis 1 mg 7 days 10 g

Sample Diluation: 1000 mg vial 10 ml water (100000g) (eq. wt. of 1000000g) 1 ml 1 ml 100 (1000g) 50 ml (20g) 1 ml 100 ml (10g)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY Material/ Product Name: Vanmycin 500 mg Injection

Standard Name: Standard Referance: Standard Source.: Standard Potency: Vancomycin HCl MB/Vanco-01/08 N/A 1010.03 g/mg

Document No. BA/VAN/02/01

Date Effective : 04.01.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Vancomycin HCl 500 mg/ vial Production 450 to 575 mg/ vial

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Test Diluation Standard Dilution: 51.5 mg std 10 ml Water (5200 g) (eq. wt. of 52000 g) 5 ml 2 ml 50 ml (500 g) 50 ml (20 g) 2 ml 100 ml (10 g) Cylinder Plate (CP) M.8(pH:)5.9 Water B4 pH:4.5 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Bacillus subtilis 1 mg 7 days 10 g

Sample Dilution: 500 mg vial (eq. wt. of 500000g)

10 ml water (50000g) 1 ml 2 ml 100 (500g) 50 ml (20g) 2 ml 100 ml (10g)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY Material/ Product Name: Vancomycin HCl Raw material

Standard Name: Standard Referance: Standard Source.: Standard Potency: Vancomycin HCl MB/Vanco-01/08 N/A 1010.03 g/mg

Document No. BA/VAN/02/01

Date Effective : 04.01.09

Stage: Active Name: CoA/ Label Clame Source: Specification:

Final Vancomycin HCl N/A N/A Not less than 900 g mg

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Test Diluation Standard Diluation: 51.5 mg std 10 ml Buffer (5200 g) (eq. wt. of 52000 g) 5 ml 2 ml 50 ml (500 g) 50 ml (20 g) 2 ml 100 ml (10 g) Cylinder Plate (CP) M.8(pH:)5.9 Water B4 pH:4.5 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Bacillus subtilis 1 mg 7 days 10 g

Sample Diluation: 51.5 mg std 10 ml Buffer (5200 g) (eq. wt. of 52000 g) 5 ml 2 ml 50 ml (500 g) 50 ml (20 g) 2 ml 100 ml (10 g)

Prepared By:

Checked By:

QC Officer, Microbiology

Asst. Manager, QC

MICROBIOLOGICAL ASSAY
Standard Name: Standard Referance: Standard Source.: Standard Potency: Neomycin sulphate 200906046 R-836/09 684 g/mg

Document No. BA/CNeo/01/01

Date Effective : 10.05.10

Material/ Product Name: CORTAN PLUS EYE SUSPENTION Stage:

Active Name: CoA/ Label Clame Source: Specification:

Final Neomycin sulphate 90% to 130% R & DF 3.5 mg Neomycin SO4/ ml suspention

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) Diethylether B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Staph. epidermidis (ATCC 12228) 1 mg/ ml 14 days 1.0 g/ ml

Test Diluation Standard Diluation: 29.25 mg 100 ml (200 g) (eq. wt. of 20000 g) 1 ml 50 ml (4 g) 1 ml 100 ml ( 2 g)

Sample Diluation: 4.17 ml Eye suspention 100 ml (100 g) (eq. wt. of 10,000 g) 2 ml 50 ml ( 4 g) 2 ml 100 ml ( 2 g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

USP 29 Assay Proceed with Capsules as directed under AntibioticsMicrobial Assays

MICROBIOLOGICAL ASSAY
Standard Name: Standard Referance: Standard Source.: Standard Potency: Polymixin B Sulphate R & DF 7780 g/mg

Document No. BA/POL/01/01

Date Effective : 10.05.10

Material/ Product Name: CORTAN PLUS EYE SUSPENTION Stage:

Active Name: CoA/ Label Clame Source: Specification:

Final Polymixin B Sulphate 90% to 130% R & DF 10000 units / ml suspention

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) Water, [ B6 ] B-6; pH = 7.2

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Bordelella bronchiseptica 10000 U 14 days 10 U/ml

Test Diluation Standard Diluation: 25.70 mg 100 ml (2000 g) (eq. wt. of 200000 g) 1 ml 50 ml (40 g) 1 ml 100 ml ( 20 g)

Sample Diluation: 2 ml Eye suspention 100 ml ( 200 g) (eq. wt. of 20,000 g) 10 ml 50 ml ( 40 g) 10 ml 100 ml ( 20 g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

USP 29 Assay Proceed with Capsules as directed under AntibioticsMicrobial Assays

MICROBIOLOGICAL ASSAY
Standard Name: Standard Referance: Standard Source.: Standard Potency: Paromomycin Sulphate WS-080803 Zhejiang Pharma. Co. Ltd. China 735 g/mg

Document No. BA/Prm/01/01

Date Effective : 10.09.09

Material/ Product Name: Paromomycin Sulphate Capsule Stage:

Active Name: CoA/ Label Clame Source: Specification:

PD Trial Paromomycin Sulphate 250 mg Paromomycin/ Capsule R & DF 225 - 312.5 mg/cap (90-125%)

Parmacopeial Information's: Test Method Test Medium Initial Solvent Final Diluent Cylinder Plate (CP) M-11 (pH: 8.3) B-3; pH = 8.0 (0.05M) B-3; pH = 8.0 (0.05M)

Referance : Test Organism Final Stock Conc. Stock Use Within Median Dose

USP 29 < 81> : 2007 Staph. epidermidis (ATCC 12228) 1 mg/ ml 21 days 1.0 g/ ml

Test Diluation Standard Diluation: 68.0 mg 100 ml (500 g) (eq. wt. of 50,000 g) 1 ml 50 ml (10 g) 100 ml (5 g)

Sample Diluation: 4 Capsule 100 ml (10000 g) (eq. wt. of 10,00,000 g) 5 ml 100 ml (500 g) 1 ml 50 ml (10 g) 100 ml (5 g)

Prepared By: QC Officer, Microbiology

Checked By: Asst. Manager, QC

USP 29 Assay Proceed with Capsules as directed under AntibioticsMicrobial Assays 81 , 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 Tes