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 2.0 percent, and it may contain one or more suitable stabilizers. It contains not less than 90.0 percent and not more than 115.0 percent 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.
USP Reference standards 11
USP Dihydrostreptomycin Sulfate RS.
USP Endotoxin RS.
USP Penicillin G Potassium RS.
Identification It responds to Identification tests A and B under Penicillin G Procaine, Dihydrostreptomycin Sulfate, Chlorpheniramine Maleate, and Dexamethasone Suspension.
Bacterial endotoxins 85 It contains not more than 0.01 USP Endotoxin Unit per 100 Penicillin G Units.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, except to use a portion of specimen from each container equivalent to 300,000 Penicillin G Units, instead of the minimum volume specified in the Table 2, Minimum Quantity to be Used for Each Medium and to use Fluid A to which has been added sufficient sterile penicillinase to inactivate the penicillin G and to swirl the vessel until solution is complete before filtering. If the Injectable Suspension contains lecithin, use Fluid D to which has been added sufficient penicillinase to inactivate the penicillin G and to swirl the vessel until solution is complete before filtering. If it contains carboxymethylcellulose sodium, add also sufficient sterile carboxymethylcellulase to Fluid A or Fluid D to 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 G in each vessel.
pH 791: between 5.0 and 8.0.
Assay for penicillin G
Standard preparation Using USP Penicillin G Potassium RS, prepare as directed for Standard preparation under Iodometric AssayAntibiotics 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 AssayAntibiotics 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, and 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 under AntibioticsMicrobial 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.
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USP32NF27 Page 3234