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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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 262
Phone Number : 1-301-816-8223