U.S. PHARMACOPEIA

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Penicillin G Benzathine Injectable Suspension
» Penicillin G Benzathine Injectable Suspension is a sterile suspension of Penicillin G Benzathine in Water for Injection with one or more suitable buffers, dispersants, preservatives, and suspending agents. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of penicillin.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I or Type II glass, in a refrigerator.
Identification— It responds to the Identification test under Penicillin G Benzathine Oral Suspension.
Bacterial endotoxins 85— It contains not more than 0.01 Endotoxin Unit per 100 Penicillin G Units.
Sterility 71— It meets the requirements when tested 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 and Soybean–Casein Digest Medium containing polysorbate 80 solution (1 in 200) and an amount of sterile penicillinase sufficient to inactivate the penicillin G in each vessel, and to shake the vessels once daily.
pH 791: between 5.0 and 7.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Standard preparation— Using USP Penicillin G Potassium RS, prepare as directed for Standard preparation under Iodometric Assay—Antibiotics 425.
Assay preparation— Using a suitable hypodermic needle and syringe, withdraw an accurately measured volume of Injectable Suspension, equivalent to about 300,000 Penicillin G Units, and dilute quantitatively with 1.0 N sodium hydroxide to obtain an Assay preparation containing about 2000 Penicillin G Units per mL. Pipet 2.0 mL of this solution into a glass-stoppered, 125-mL conical flask.
Blank preparation— Using a suitable hypodermic needle and syringe, withdraw an accurately measured volume of Injectable Suspension, equivalent to about 300,000 Penicillin G Units, and quantitatively dilute with Buffer No. 1 to obtain a suspension containing about 2000 Penicillin G Units per mL. Pipet 2 mL of this solution into a glass-stoppered, 125-mL conical flask.
Procedure— Proceed as directed for Procedure under Iodometric Assay—Antibiotics 425, except in performing the Inactivation and Titration to omit the addition of 1.0 N sodium hydroxide to the Assay preparation, and in performing the Blank Determination to use the Blank preparation in place of the Assay preparation. Calculate the quantity, in Penicillin G Units, in each mL of the Injectable Suspension taken by the formula:
(L / 2D)(F)(B I),
in which L is the labeled quantity, in Penicillin G Units per mL, in the Injectable Suspension taken, and D is the concentration, in Penicillin G Units per mL, in the Assay preparation on the basis of the labeled quantity in the Injectable Suspension and the extent of dilution, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1654
Phone Number : 1-301-816-8223