DocetaxelInjection（多西他赛注射液）.pdfVIP

Accessed from 10.6.1.1 by halifax7 on Mon Aug 22 19:52:33 EDT 2016 USP 39 Official Monographs / Docetaxel 3567 • PACKAGING AND STORAGE: Preserve in well-closed, light- TLC tank: Lined with filter paper resistant containers, and store at room temperature. Analysis: After removing the plate from the tank, allow • USP REFERENCE STANDARDS 〈11〉 to dry in a fume hood, and view under UV light at 254 USP Docetaxel RS nm. USP Docetaxel Identification RS Acceptance criteria: Meets the requirements It contains docetaxel and small amounts of the • B. The retention time of the major peak of the Sample following: solution corresponds to that of the Standard solution, as 2-Debenzoxyl 2-pentenoyl docetaxel: (2aR,4S,4aS,6R,9S, obtained in the Assay. 11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b- Dodecahydro-4,6,9,11,12,12b-hexahydroxy-4a,8,13, ASSAY 13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz • PROCEDURE [1,2-b]oxet-5-one 12b-acetate, 12-[(E)-2-methylbut- Solution A: Water 2-enoate], 9-ester with (2R,3S)-N-tert-butoxycarbonyl- Solution B: Acetonitrile 3-phenylisoserine. Mobile phase: See Table 1. C41 H55 NO14 785.87 6-Oxodocetaxel: (2aR,4S,4aS,9S,11S,12S,12aR,12bS)- Table 1 1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4