BRIEFING
Argatroban in Sodium Chloride Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. On the basis of comments received, the proposal previously published in PF 46(6) [Nov.–Dec. 2020] has been canceled and is being replaced with this new proposal.
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The liquid chromatographic procedure in the Assay is based on analyses performed with the Kinetex C18 brand of column with L1 packing. The typical retention times for argatroban R-epimer and argatroban S-epimer are about 12.8 and 13.5 min, respectively.
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The liquid chromatographic procedure in the Organic Impurities test is based on analyses performed with the Zorbax SB-C18 brand of column with L1 packing. The typical retention times for argatroban R-epimer and argatroban S-epimer are about 19.2 and 20.3 min, respectively.
(SM2: W. Yang)
Correspondence Number—C256615