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Irinotecan Hydrochloride

Type of Posting: Revision Bulletin

Posting Date: 30–Sep–2010; updated 15–Oct–2010*

Official Date: 01–Oct–2010

Expert Committee: Monographs—Small Molecules 3

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee (SM3) has revised the Irinotecan Hydrochloride monograph. Using a flexible monograph approach, an Organic Impurities Procedure 2 is added to the monograph, to accommodate the material produced by a semi-synthetic process. A note is added to specify that the currently official Organic Impurity procedure is now designated as Procedure 1, and should be used for material produced by a synthetic process.

This newly added liquid chromatographic procedure was previously published on the USP Pending Monographs website as a part of the Authorized Pending Monograph. It is based on analyses performed with the Waters Symmetry Shield brand of L1 column. The typical retention times for irinotecan and irinotecan related compound A are about 15.8 and 18.2 min, respectively.

To address the difficulties reported in meeting the system suitability requirements under the Limit of Irinotecan Hydrochloride Enantiomer, the relative standard deviation is revised from "NMT 2.0%" to "NMT 5.0%". This new system suitability precision criterion is suitable for a solution with a concentration of 1.5 µg/mL, which is 0.15% of the Sample solution concentration.

This Irinotecan Hydrochloride Revision Bulletin supersedes the currently official Irinotecan Hydrochloride monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 34–NF 29.

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

* Replaced Revision Bulletin file to remove editing artifact. No text was changed.