Benzylpenicilloyl Polylysine Injection
» Benzylpenicilloyl Polylysine Injection has a molar concentration of benzylpenicilloyl moiety (C16N2H19O5S) of not less than 5.4 × 105 M and not more than 7.0 × 105 M. It contains one or more suitable buffers.
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, in a refrigerator.
Bacterial endotoxins 85— It contains not more than 5833.0 USP Endotoxin Units per mL.
Sterility 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.
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 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.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161		 (MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1653