Penicillin G Procaine for Injectable Suspension
»Penicillin G Procaine for Injectable Suspension is a sterile mixture of Penicillin G Procaine and one or more suitable buffers,dispersants,or suspending agents,and preservatives.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of penicillin G,the labeled amount being not less than 300,000Penicillin G Units per container or per mLof constituted Suspension.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Ior Type IIIglass.
Identification— It responds to the Identificationtest under Penicillin G Procaine.
pHá791ñ: between 5.0and 7.5,when constituted as directed in the labeling.
Water,Method Iá921ñ: between 2.8%and 4.2%.
Other requirements— It meets the requirements for Bacterial endotoxinsand Sterilityunder Penicillin G Procaine Injectable Suspension.It meets also the requirements under Injections á1ñand Uniformity of Dosage Units á905ñ.
Assay—
Standard preparation— Using USP Penicillin G Potassium RS,prepare as directed for Standard preparationunder Iodometric Assay—Antibiotics á425ñ.
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Penicillin G Procaine for Injectable Suspension as directed in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute 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.
Assay preparation 2 (where the label states the quantity of penicillin Gprocaine in a given volume of constituted suspension)—Constitute Penicillin G Procaine for Injectable Suspension as directed in the labeling.Dilute an accurately measured volume of the constituted 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.Calculate the quantity,in Penicillin G Units,in the container,or in the portion of constituted injectable suspension taken by the formula:
(L/2D)(F)(B-I),
in which Lis the labeled quantity,in Penicillin G Units,in the container,or in the volume of constituted injectable suspension taken,and Dis the concentration,in Penicillin G Units per mL,of Assay preparation 1or of Assay preparation 2on the basis of the labeled quantity in the container or in the portion of constituted injectable suspension taken,respectively,and the extent of dilution.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1491
Phone Number:1-301-816-8335