N-Decanoyl-l-tryptophyl-d-asparaginyl-l-aspartyl-l-threonylglycyl-l-ornithyl-l-aspartyl-d-alanyl-l-aspartylglycyl-d-seryl-threo-3-methyl-l-glutamyl-3-anthraniloyl-l-alanine ε1-lactone. [103060-53-3]
BRIEFING
Daptomycin. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The UHPLC procedures in the Assay and in the test for Organic Impurities, Procedure 1 were validated using two columns connected in series, both the Acquity UPLC CSH C18 brand of column with L1 packing. The typical retention time for daptomycin is about 23 min.
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The liquid chromatographic procedure in the test for Organic Impurities, Procedure 2 was validated using the IB-SIL C8 brand of column with L7 packing. The typical retention time for daptomycin is about 34 min.
Description and solubility information: Pale yellow to light brown powder. Freely soluble in water, slightly soluble in alcohol and practically insoluble in ether and chloroform.
(SM1: S. Shane)
Case ID—SUB-1254, SUB-1272, SUB-1273