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.
USP Reference standards 11
USP Endotoxin RS. USP Penicillin G Potassium RS. USP Procaine Hydrochloride RS.
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%.
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 AssayAntibiotics 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 AssayAntibiotics 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
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USP32NF27 Page 3233
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