U.S. PHARMACOPEIA

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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 90.0 percent and not more than 115.0 percent of the labeled amount of penicillin G, the labeled amount being not less than 300,000 Penicillin G Units per container or per mL of constituted Suspension.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I or Type III glass.
Identification— It responds to the Identification test under Penicillin G Procaine.
pH 791: between 5.0 and 7.5, when constituted as directed in the labeling.
Water, Method I 921: between 2.8% and 4.2%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Bacterial endotoxins and Sterility under Penicillin G Procaine Injectable Suspension. It meets also the requirements under Injections 1 and Uniformity of Dosage Units 905.
Assay—
Standard preparation— Using USP Penicillin G Potassium RS, prepare as directed for Standard preparation under Iodometric Assay—Antibiotics 425.
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. 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.
Assay preparation 2 (where the label states the quantity of penicillin G procaine 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. 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. 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 L is the labeled quantity, in Penicillin G Units, in the container, or in the volume of constituted injectable suspension taken, and D is the concentration, in Penicillin G Units per mL, of Assay preparation 1 or of Assay preparation 2 on 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 : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1662
Phone Number : 1-301-816-8223