Penicillin G Procaine and Dihydrostreptomycin Sulfate Injectable Suspension
»Penicillin G Procaine and Dihydrostreptomycin Sulfate Injectable Suspension is a sterile suspension of Penicillin G Procaine in a solution of Dihydrostreptomycin Sulfate in Water for Injection,and contains one or more suitable buffers,preservatives,and dispersing or suspending agents.It may contain Procaine Hydrochloride in a concentration not exceeding 2.0percent,and it may contain one or more suitable stabilizers.It contains not less than 90.0percent and not more than 115.0percent of the labeled amounts of Penicillin G Units and of dihydrostreptomycin (C21H41N7O12).
Packaging and storage— Preserve in single-dose or multiple-dose,tight containers.
Labeling— Label it to indicate that it is intended for veterinary use only.
Identification— It responds to Identificationtests Aand Bunder Penicillin G Procaine,Dihydrostreptomycin Sulfate,Chlorpheniramine Maleate,and Dexamethasone Suspension.
Bacterial endotoxins á85ñ— It contains not more than 0.01USP Endotoxin Unit per 100Penicillin G Units.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,except to use a portion of specimen from each container equivalent to 300,000Penicillin G Units,instead of the minimum volume specified in the Table 2,Minimum Quantity to be Used for Each Mediumand to use Fluid Ato which has been added sufficient sterile penicillinase to inactivate the penicillin Gand to swirl the vessel until solution is complete before filtering.If the Injectable Suspension contains lecithin,use Fluid Dto which has been added sufficient penicillinase to inactivate the penicillin Gand to swirl the vessel until solution is complete before filtering.If it contains carboxymethylcellulose sodium,add also sufficient sterile carboxymethylcellulase to Fluid Aor Fluid Dto dissolve the carboxymethylcellulose sodium before filtering.If it does not dissolve completely,proceed as directed for Direct Inoculation of the Culture Medium under Test for Sterility of the Product to be Examined,except to use Fluid Thioglycollate Medium containing an amount of sterile penicillinase sufficient to inactivate the penicillin Gin each vessel.
pHá791ñ: between 5.0and 8.0.
Assay for penicillin G—
Standard preparation— Using USP Penicillin G Potassium RS,prepare as directed for Standard preparationunder Iodometric Assay—Antibiotics á425ñ.
Assay preparation— Dilute an accurately measured volume of Injectable Suspension quantitatively with Buffer No.1to obtain a solution containing about 2000Penicillin G Units per mL.Pipet 2mLof this solution into each of two glass-stoppered,125-mLconical flasks.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ,except in the Blank Determinationto add 0.1mLof 1.2Nhydrochloric acid immediately before the 10.0mLof 0.01Niodine VS.Calculate the quantity,in Penicillin G Units,in the portion of Injectable Suspension taken by the formula:
(L/2D)(F)(B-I),
in which Lis the labeled quantity,in Penicillin G Units,in the volume of Injectable Suspension taken,and Dis the concentration,in Penicillin G Units per mL,of the Assay preparation,on the basis of the labeled quantity in the portion of Injectable Suspension taken and the extent of dilution,and the other terms are as defined therein.
Assay for dihydrostreptomycin— Proceed as directed for the turbidimetric assay for dihydrostreptomycin under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Injectable Suspension diluted quantitatively with water to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1492
Phone Number:1-301-816-8178
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