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 90.0percent and not more than 115.0percent of the labeled amount of penicillin.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Ior Type IIglass,in a refrigerator.
Identification— It responds to the Identificationtest under Penicillin G Benzathine Oral Suspension.
Bacterial endotoxins á85ñ— It contains not more than 0.01Endotoxin Unit per 100Penicillin G Units.
Sterility á71ñ— 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 80solution (1in 200)and an amount of sterile penicillinase sufficient to inactivate the penicillin Gin each vessel,and to shake the vessels once daily.
pHá791ñ: between 5.0and 7.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard preparation— Using USP Penicillin G Potassium RS,prepare as directed for Standard preparationunderIodometric Assay—Antibiotics á425ñ.
Assay preparation— Using a suitable hypodermic needle and syringe,withdraw an accurately measured volume of Injectable Suspension,equivalent to about 300,000Penicillin G Units,and dilute quantitatively with 1.0Nsodium hydroxide to obtain an Assay preparationcontaining about 2000Penicillin G Units per mL.Pipet 2.0mLof this solution into a glass-stoppered,125-mLconical flask.
Blank preparation— Using a suitable hypodermic needle and syringe,withdraw an accurately measured volume of Injectable Suspension,equivalent to about 300,000Penicillin G Units,and quantitatively dilute with Buffer No.1to obtain a suspension containing about 2000Penicillin G Units per mL.Pipet 2mLof this solution into a glass-stoppered,125-mLconical flask.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ,except in performing the Inactivation and Titrationto omit the addition of 1.0Nsodium hydroxide to the Assay preparation,and in performing the Blank Determinationto use the Blank preparationin place of the Assay preparation.Calculate the quantity,in Penicillin G Units,in each mLof the Injectable Suspension taken by the formula:
(L/2D)(F)(B-I),
in which Lis the labeled quantity,in Penicillin G Units per mL,in the Injectable Suspension taken,and Dis the concentration,in Penicillin G Units per mL,in the Assay preparationon 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:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1484
Phone Number:1-301-816-8335