Benzylpenicilloyl Polylysine Injection
»Benzylpenicilloyl Polylysine Injection has a molar concentration of benzylpenicilloyl moiety (C16N2H19O5S)of not less than 5.4×10-5Mand not more than 7.0×10-5M.It contains one or more suitable buffers.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,in a refrigerator.
Bacterial endotoxins á85ñ— It contains not more than 5833.0USP Endotoxin Units per mL.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 6.5and 8.5.
Assay—
Saline phosphate buffer and Mercuric chloride solution—Prepare as directed in the Assayunder Benzylpenicilloyl Polylysine Concentrate.
Assay preparation— Combine the contents of a sufficient number of containers to obtain not less than 3mLof Injection.Transfer 3.0mLof Injection to a 10-mLvolumetric flask,dilute with Saline phosphate bufferto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Benzylpenicilloyl Polylysine Concentrate.Calculate the molar concentration of benzylpenicilloyl moiety in the Injection taken by the formula:
(10/3){[Am(3+0.02n)/3]-Ai}/22,325b,
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 240
Phone Number:1-301-816-8335