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 Injection monograph. The purpose of the revision is to make the following changes in the Organic impurities procedure:
- Widen the limit of 4-epidocetaxel from NMT 0.5% to NMT 1.0% to reflect the FDA-approved specification. The limit of total impurities remains unchanged.
- In footnote b of Table 2, add clarification that 2-debenzoxyl 2-pentenoyl docetaxel is a process impurity and it is controlled in the drug substance. It is not reported for the drug product and should not be included in the Total impurities.
- Revise the alternative chemical names in footnotes b, c, d and e of Table 2 to be consistent with the updated impurity chemical names in Docetaxel monograph in European Pharmacopoeia 7.5.
The Docetaxel Injection Revision Bulletin replaces the monograph in USP35–NF30, which is scheduled to become official on May 1, 2012. The Revision Bulletin will be incorporated in the USP36–NF31.
Should you have any questions, please contact Feiwen Mao (301-816-8320 or email@example.com).