Docetaxel

Type of Posting: Revision Bulletin

Posting Date: 30–Mar–2012

Official Date: 01–May–2012

Expert Committee: Monographs—Small Molecules 3

Reason for Revision: Compliance/Correction to test

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Docetaxel monograph.

This revision accommodates the sponsors’ FDA-approved specifications as follows:

  • Using a flexible monograph approach, add Organic Impurities Procedure 2 to the monograph to accommodate the material produced by a different synthetic process. A note is added to specify that the currently official Organic Impurities procedure is now designated as Procedure 1. The newly added liquid chromatographic procedure is based on analyses performed with a Waters SunFire C18 brand of L1 column. The typical retention time for docetaxel is about 19 min.
  • Add docetaxel alcohol as a specified impurity with acceptance criterion of “NMT 0.15%” to the Table 2 under Organic Impurities Procedure 1.
  • Add an anhydrous form of docetaxel to the monograph. Delete the term “trihydrate” from the chemical names and delete “3H2O” from the structure, and add the CAS number for anhydrous form in the chemical information section.
  • Revise the test for Water Determination to add a limit of “NMT 1.5%” which applies to the anhydrous form of docetaxel.
  • Revise the test for Specific Rotation to add an acceptance range of “-35° to -45° on the as-is basis” which applies to the anhydrous form of docetaxel.
  • Widen the acceptance criterion under Bacterial Endotoxins from “NMT 0.3 USP Endotoxin Units/mg” to “NMT 0.4 USP Endotoxin Units/mg”.

This revision also includes an addition of a detailed procedure to the test for Heavy Metals, previously presented for public comments in PF 37(6) [Nov-Dec 2011] as a Proposed Interim Revision Announcement. No comments were received.

This Docetaxel Revision Bulletin supersedes the currently official monograph, and will be incorporated in the USP 36–NF 31.

Should you have any questions, please contact Feiwen Mao, M.S. (301-816-8320 or fm@usp.org).