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.
Saline phosphate buffer and Mercuric chloride solutionPrepare 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.
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USP32NF27 Page 1653