PENCIN - LA INJECTION 100ml

(penicillin G and Dihydrostreptomycin injection)

Bulk Analysis Report
Status 01 Issue date 26.4.16
Doc.# STR/QC/BAR- V-139c
Page1of 1 rev. date April.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: _____________Q.C. No.: ______________

Mfg. Date: _____________Exp. Date: ______________ D.R. No.: ____063626______

Ref: Star specs
Sr.# TESTS SPECIFICATIONS RESULTS
White to off white injectable suspension,
1. Description
free from particulate matter.
Penicillin G should be identified
2. Identification Dihydrostreptomycin Sulphate should be
identified
3 pH 5.0 to 8.0
45.0 – 55.0 % of the stated amount
4
Contents of Total Penicillin G (Stated amount 0.2339gm Penicillin G
Procaine + Penicillin G Benzathine/ml )
Contents of Benzathine
5 90,000 i.u to 110,000 iu/ml
Penicillin G
6 Procaine Penicillin G 135,000 i.u to 165000 i.u /ml
Contents of 180mg to 220mg / ml
7
Dihydrostreptomycin 90.0 – 110.0% of the stated amount
Remarks:

Analyst: ______________ Deputy QCM / Q.C. Manager______________

 PENCIN - LA INJECTION 50ml
(penicillin G and Dihydrostreptomycin injection)
Certificate of Analysis
Status 01 Issue date 26.4.16
Doc.# STR/QC/COA- VF-139a
Page1of 1 rev. date April.2019
Finished product D.R. No.: 063626
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: _____________Q.C. No.: _________________

Mfg. Date: _____________Exp. Date: ______________ Released on:______________

Ref: Star specs
Sr.# TESTS SPECIFICATIONS RESULTS
1. White to off white injectable suspension, free
from particulate matter. filled in amber glass
Description vial, closed with rubber closure, sealed with
tear off seal, neatly labeled and packed in a
unit carton.
2. Penicillin G Should be identified
Identification Dihydrostreptomycin Sulphate Should be
identified
3 PH 5.0 to 8.0
4 Average volume filled per vial 50ml to 51.0ml
5 Bacterial Endotoxin Test NMT 83.3 E.U/ml
6
Sterility Test Should be Sterile

7 Benzathine Penicillin G 90,000 i.u / ml to 110,000 iu / ml

8 Procaine Penicillin G 135,000 i.u / ml to 165000 i.u / ml
9 180mg to 220mg / ml
Assay
(Contents of Dihydrostreptomycin )
90.0 – 110.0% of the stated amount
Remarks:
Analyst: Microbiologist Deputy QCM Q.C. Manager