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Polymyxin B for Injection

BRIEFING

 Polymyxin B for Injection. This proposal is based on the version of the monograph official as of January 1, 2018. It is proposed to revise the monograph with the following changes:

  1. In Identification A, replace the TLC test with a more specific infrared spectroscopy test.

  2. Add Identification B based on the retention time agreement with the HPLC procedure in the Composition of Polymyxins test.

  3. Add an Organic Impurities test and Composition of Polymyxins test based on a validated liquid chromatographic procedure. The proposed procedure is based on analyses performed with the Symmetry Shield RP-18 brand of column with L1 packing. The typical retention time for polymyxin B1 is about 44.0 min.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (BIO4: Y. Han)

 Correspondence Number—C296667

USP REFERENCE STANDARDS FOR PURCHASE

USP Polymyxin B Sulfate RS
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