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Penicillin G Procaine, Dihydrostreptomycin Sulfate, and Prednisolone Injectable Suspension
» Penicillin G Procaine, Dihydrostreptomycin Sulfate, and Prednisolone Injectable Suspension is a sterile suspension of Penicillin G Procaine and Prednisolone in a solution of Dihydrostreptomycin Sulfate in Water for Injection. It contains one or more suitable buffers, dispersants, preservatives, and suspending agents. It may contain not more than 2.0 percent of procaine hydrochloride, and one or more suitable stabilizing agents. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled number of Penicillin G Units, not less than 90.0 percent and not more than 115.0 percent of the labeled amount of dihydrostreptomycin (C21H41N7O12), and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of prednisolone (C21H28O5).
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, and is not to be used in animals to be slaughtered for human consumption.
Identification— It responds to Identification tests A and B under Penicillin G Procaine, Dihydrostreptomycin Sulfate, Chlorpheniramine Maleate, and Dexamethasone Injectable Suspension.
Bacterial endotoxins 85— It contains not more than 0.01 Endotoxin Unit per 100 Penicillin G Units.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements of the test for Sterility, and for pH under Penicillin G Procaine and Dihydrostreptomycin Sulfate Injectable Suspension.
Assay for penicillin G—
Standard preparation— Using USP Penicillin G Potassium RS, prepare as directed for Standard preparation under Iodometric Assay—Antibiotics 425.
Assay preparation— Dilute an accurately measured volume of Injectable Suspension quantitatively with Buffer No. 1 to obtain a solution containing about 2000 Penicillin G Units per mL. Pipet 2 mL of this solution into each of two glass-stoppered, 125-mL conical flasks.
Procedure— Proceed as directed for Procedure under Iodometric Assay—Antibiotics 425, except in the Blank Determination to add 0.1 mL of 1.2 N hydrochloric acid immediately before the 10.0 mL of 0.01 N iodine 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 L is the labeled quantity, in Penicillin G Units, in the volume of Injectable Suspension taken, D is 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 as directed under Antibiotics—Microbial Assays 81, using an accurately measured volume of Injectable Suspension diluted quantitatively with water to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Assay for prednisolone—
Standard preparation— Prepare as directed for Standard Preparation under Single-steroid Assay 511, using USP Prednisolone RS.
Assay preparation— Transfer to a separator an accurately measured volume of Injectable Suspension, and add 15 mL of water. Extract with three 25-mL portions and finally with one 20-mL portion of chloroform, filtering each portion through chloroform-washed cotton into a 100-mL volumetric flask. Add chloroform to volume, and mix. Pipet 20 mL of this solution into a suitable glass-stoppered flask or tube, evaporate the chloroform on a steam bath just to dryness, cool, and dissolve the residue in 2.0 mL, accurately measured, of a mixture of equal volumes of chloroform and alcohol.
Procedure— Proceed as directed for Single-Steroid Assay 511, using Solvent A to develop the chromatogram. Calculate the quantity, in mg, of prednisolone (C21H28O5) in each mL of the Injectable Suspension taken by the formula:
0.01(C / V)(AU / AS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison : Ian DeVeau, Ph.D., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29–NF24 Page 1665
Phone Number : 1-301-816-8178