Benzylpenicilloyl Polylysine Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Benzylpenicilloyl Polylysine Injection has a molar concentration of benzylpenicilloyl moiety (C16N2H19O5S) of not less than 5.4 × 10−5M and not more than 7.0 × 10−5M. It contains one or more suitable buffers
1 Packaging and storage
Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, in a refrigerator.
BACTERIAL ENDOTOXINS TEST (85). It contains not more than 5833.0 USP Endotoxin Units per mL.
STERILITY TESTS (71). -It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
PH (791): between 6.5 and 8.5.
2 Assay
Saline phosphate buffer and Mercuric chloride solution-Prepare as directed in the Assay, under Benzylpenicilloyl Polylysine Concentrate.
Assay preparation-Combine the contents of a sufficient number of containers to obtain not less than 3 mL of Injection. Transfer 3.0 mL of Injection to a 10-ml volumetric flask, dilute with Saline phosphate buffer to volume, and mix.
Procedure-Proceed as directed for Procedure in the Assay under Benzylpenicilloyi 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.
