Pencin-LA Injection 100ml

(Penicillin G and Dihydrostreptomycin Injection)

Batch Analysis sheet
Status 01 Issue Date 26.04.2016
Document# STR/QC/BAS- V-139
Rev. Date 26.04.2019

Product Name: Pencin - LA Injection Date: _____________

Generic Name: Penicillin G and Dihydrostreptomycin Injection Suspension
Composition:
Each ml contains:
Benzathine penicillin G (BP)....................................................................................100,000 IU
Procaine penicillin G (BP)........................................................................................150,000 IU
Dihydrostreptomycin sulfate eq to Dihydrostreptomycin base (BP. Vet) ....................200mg

Batch No.: _____________ Batch Size: _____________ QC. No.: ______________

Mfg. Date: _____________ Exp. Date: ______________ DR. No.: 063626

STAGE I (Bulk)
Quantity of the Sample: ________________ Sample Taken By: ___________________

Ref: Star Specs

Sr.# Tests Specifications Results
1. White to off white injectable suspension, free
Description
from particulate matter.
2.
Identification All APIs should be identified
3.
pH 5.0 to 8.0
Assay 45.0 – 55.0 % of the stated amount
4.
(Contents of Total (Stated amount 0.2339gm Penicillin G Procaine +
Penicillin G) Penicillin G Benzathine/ml)
5.
Benzathine Penicillin G 90,000 to 110,000iu/ml
6.
Procaine Penicillin G 135,000 to 165000i.u/ml
Assay 90.0 – 110.0% of the stated amount
7.
(Contents of
Dihydrostreptomycin ) 180mg to 220mg/ml
1-Description:
White to off white injectable suspension, free from particulate matter.
2-Identification:
Complies as per method followed in assay preparation.
3-pH:
Measure the pH on calibrated PH meter, which should be in range 5.0 to 8.0
4-Assay
Reagents:
1. Mono basic potassium phosphate.
2. Methanol AR grade
3. Acetonitrile AR grade

Page 1 of 5
 Pencin-LA Injection 100ml
(Penicillin G and Dihydrostreptomycin Injection)
Batch Analysis sheet
Status 01 Issue Date 26.04.2016
Document# STR/QC/BAS- V-139
Rev. Date 26.04.2019

Buffer: 0.05M phosphate buffer pH 6.0 dissolver 6.8 g of monobasic potassium phosphate in 900ml of
water, adjusts with the 1M sodium hydroxide to a pH 6.0 dilute with water to 1000ml and mix.
Mobile Phase:
Prepare a mixture of 0.05M phosphate buffer pH: 6.0 and acetonitrile (800:200) pass through a
membrane filter having 0.45um or finer porosity and degas. Make adjustment if necessary.
Standard preparation:
Weigh accurately 84.52mg of benzathine penicillin equivalent to (100,000 iu/ml and 150.0 mg of
Procain penicillin G is (equivalent to 150,000 iu/mg into 250 ml Volumetric flask, add 25 ml of
Acetonitrile and 15 ml of methanol and swirl to dissolve without delay, dilute with 0.05 M phosphate
buffer pH: 6.0 to volume and mix after stirring for 60mints.
Sample Preparation
Measure Volume accurately 1.0 ml is equivalent to benzathine penicillin G 84.52 and procain Penicillin
G 150.0 iu/ 1500.0 mg into 250 ml volumetric flask, add 25 ml Acetonitrile and 15ml of methanol
shake well to dissolve, add 0.05 M phosphate buffer pH:6.0 without delay make up the volume upto
the mark with 6.0 phosphate buffer Solution Stirring the solution for 10 mints and filter through filter
paper whatman No. 4 and then 0.45 µm filter paper: final conc be. For benzathine penicillin:
0.338mg/ml and final conc. For Procain penicillin G 0.600 mg/ml.
Chromatographic Conditions;
Column length : 250x4.6,15 µm,
UV detector wave length : 225 nm
Flow rate : 1.0 ml/min
Column oven : Ambient
Procedure:
Separately inject equal Volumes about 20 ml of the Standard preparation and Sample preparation into
Chromatograph, record the Chromatogram and measure the response for major peaks. Peaks order
will be as first peak will be procaine penicillin G and 2nd major peak will be benzathine penicillin G.
Assay calculation avg.peak area of sample x conc of std. x 100 = %
age for procaine Penicilline G = avg. = peak area of std. x conc. of sample

avg.peak area of sample x conc of std. x 100 = %

age for Benzatheine Penicilline G = avg. peak area of std. x conc. of sample

5-Determined Quantity (of Benzathine Penicillin G)

x 100,000 i.u = i.u/ml

100
6-Determined Quantity (of Procaine Penicillin G)

X 150,000 i.u = i.u/ml

100

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 Pencin-LA Injection 100ml
(Penicillin G and Dihydrostreptomycin Injection)
Batch Analysis sheet
Status 01 Issue Date 26.04.2016
Document# STR/QC/BAS- V-139
Rev. Date 26.04.2019

7- Contents of Dihydrostreptomycin:
Standard Preparation:
Weigh accurately DihydroStreptomycin Sulphate, (ref std/w std) eq. to 100 mg of Dihydrostreptomycin
in volumetric flask, and make the volume up to 50 ml with Distilled water (2mg/ml) Take 1.0 ml in 25ml
volumetric flask; add 1 ml of Nitroprusside reagent (equal volume of 10 % NaOH, 10 % potassium
ferricyanide and 1.0 % sodium Nitroprusside solutions) and stay for 10 minutes at room temperature.
Sample Preparation:
Take 1ml of injectable suspension ( eq. to 200 mg of Dihydrostreptomycin) in 100 ml volumetric flask,
and make up the volume with Distilled water (2mg/ml) Take 1.0 ml in 25ml volumetric flask; add 1 ml of
Nitroprusside reagent (equal volume of 10 % NaOH, 10 % potassium ferricyanide and 1.0 % sodium
Nitroprusside solutions) and stay for 10 minutes at room temperature.
Measure the absorption of sample and standard preparations at 490 nm on U.V Spectrophotometer and
calculate the contents of Dihydrostreptomycin.

Abs of sample x 100 = % of the stated amount

Abs of standard

Determined quantity (of Dihydrostreptomycin)

x 200 = mg/ml
100
Remarks:

Analyst: ___________________ Q.C. Manager__________________

STAGE II (Filled Vials)

Quantity of the Sample: ________________ Sample Taken By: _____________________

Ref: Star Specs

Sr.# Tests Specifications Results
White to off white injectable suspension, free
1. from particulate matter.filled in amber glass
Description
vial, closed with rubber closure, sealed with
tear off seal.
2.
Identification All APIs should be identified
3.
pH 5.0 to 8.0
4.
Average Volume Filled/Vial 100ml to 102ml

STAGE III (Finished product)

Quantity of the Sample: ______________ Sample Taken By: ____________________

Page 3 of 5
 Pencin-LA Injection 100ml
(Penicillin G and Dihydrostreptomycin Injection)
Batch Analysis sheet
Status 01 Issue Date 26.04.2016
Document# STR/QC/BAS- V-139
Rev. Date 26.04.2019

5-Assay (Contents of Total Penicillin G)

x x 0.003344 x 100 = % of the stated amount

0.00232

8-Determined Quantity (of Benzathine Penicillin G)

x 100,000 i.u = i.u/ml

50.0

9-Determined quantity (of Procaine Penicillin G)

x 150,000 i.u = i.u/ml

50.0

10- Contents of Dihydrostreptomycin:

Abs of sample x 100 = % of the stated amount

Abs of standard

Determined quantity (of Dihydrostreptomycin)

x 200 = mg/ml
100

(Finished COA)
Ref: Star Specs
Sr.# Tests Specifications Results

Page 4 of 5
 Pencin-LA Injection 100ml
(Penicillin G and Dihydrostreptomycin Injection)
Batch Analysis sheet
Status 01 Issue Date 26.04.2016
Document# STR/QC/BAS- V-139
Rev. Date 26.04.2019

White to off white injectable suspension,

free from particulate matter. Filled in
1.
Description amber glass vial, closed with rubber
closure, sealed with tear off seal, neatly
labeled and packed in a unit carton.
2.
Identification All APIs should be identified
3.
pH 5.0 to 8.0
4.
Average Volume Filled/vial 100ml to 102ml
Assay 45.0 – 55.0 % of the stated amount
5.
(Contents of Total (Stated amount 0.2339gm Penicillin G
Penicillin G) Procaine + Penicillin G Benzathine/ml)
6.
Endotoxin Test NMT 83.3 E.U/ml
7.
Sterility Tests Should be Sterile
8.
Benzathine Penicillin G 90,000 to 110,000iu/ml
9.
Procaine Penicillin G 135,000 to 165000i.u/ml
Assay 90.0 – 110.0% of the stated amount
10.
(Contents of
Dihydrostreptomycin ) 180mg to 220mg/ml

Remarks:

Analyst: ___________________ Q.C. Manager__________________

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