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)



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


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)



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


(eq. wt. of 50,000 µg) ↓ (eq. wt. of 50,000 µg) ↓ 1 ml

↓

0 Checked By:


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


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


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)



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




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)



5 mg Neomycin SO4/ gm ointment


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












Material/ Product Name: Nyclobate NN Cream (Neomycin) Stage: FinalStandard Name: Neomycin sulphate Active Name: Neomycin sulphate



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








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:


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


(eq. wt. of 50,000 µg) ↓ (eq. wt. of 50,000 µg) ↓ 1 ml

↓



68.0 mg →→→ →→ 100 ml (500 µg) 68.0 mg →→→

→→→ 50 ml (10 µg)

→→ → 100 ml (5 µg)


FinalParomomycin SulphateN/AN/A 90-125%

USP 29 < 81> : 2007

1 mg/ ml21 days

1.0 µg/ ml

↓ ↓ 1 ml

↓


→→ 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:


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


(eq. wt. of 50,000 µg) ↓ (eq. wt. of 10,00,000 µg) ↓ 1 ml

↓



68.0 mg →→→ →→ 100 ml (500 µg) 4 Capsule →→

→→→ 50 ml (10 µg)

→→ → 100 ml (5 µg)


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

↓


→→ 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:


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


(eq. wt. of 1000 µg) ↓ (eq. wt. of 1000 µg) ↓ 1 ml

↓



13 mg →→→ →→ 10ml (0.01 N HCl) 13 mg →→→

→→→ 50 ml (1IU)

→→ → 100 ml (0.5 IU)


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


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 ↓



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


(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

↓ ↓ ↓ ↓



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)


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


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


(eq. wt. of 100000 IU) ↓ (eq. wt. of 100000 IU) ↓ ↓ 2 ml ↓ 2 ml ↓ ↓

↓ ↓ →→→→ 100 ml (20 IU) →→→→ 100 ml (20 IU)



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 ↓ ↓

↓ ↓


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)


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


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


41.0 mg std 5.0 ml(eq. wt. of 25000 µg) ↓ (eq. wt. of 25000 µg) ↓

↓ 100 µl ↓ 100 µl ↓ ↓

↓ ↓



→→ 25 ml (1000 µg) →→ 25 ml (1000 µg)

↓ →→→ 100 ml (1 µg) ↓ →→→ 100 ml (1 µg)

↓ →→ →→ 50 ml (2 µg) ↓ →→ →→ 50 ml (2 µg)


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


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


41.0 mg std 41.0 mg std(eq. wt. of 25000 µg) ↓ (eq. wt. of 25000 µg) ↓

↓ 100 µl ↓ 100 µl ↓ ↓

↓ ↓



→→ 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


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)

↓



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


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


(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)



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)


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



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)



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)


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




(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)



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




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)



USP 29


↓ 1 ml

Assay— Proceed with Capsules as directed under Antibiotics—Microbial Assays

http://127.0.0.1:29241/uspnf/pub/data/v29241/usp29nf24s1_c81.xml#usp29nf24s1_c81

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


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


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)



USP 29

↓ 1 ml



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%)


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


(eq. wt. of 50,000 µg) ↓ (eq. wt. of 10,00,000 µg) ↓ 5 ml ↓ 1 ml

↓ ↓ ↓ 1 ml

↓



USP 29

81


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)


, 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



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