Revision Bulletin

Irinotecan Hydrochloride

In accordance with the Rules and Procedures of the 2005-2010 Council of Experts and the USP Pending Monographs Guideline, the Monograph Development—Ophthalmology, Oncology, and Dermatology (MDOOD) Expert Committee has approved the Irinotecan Hydrochloride monograph to move from an Authorized Pending Monograph to official USP-NF status. At the time of approval of the official monograph, the Expert Committee incorporated changes to the Authorized text in order to accommodate information provided by another FDA approved manufacturer: The following is a summary of the comments received:

Section: Specific rotation
Expert Committee-initiated Change: The Expert Committee initiated deletion of the test for Specific rotation because the monograph includes a quantitative chromatographic test for the Limit of irinotecan hydrochloride enantiomer and the Specific rotation test is redundant

Section: Related compounds/TEST #
Expert Committee-initiated Change: The Expert Committee decided that TEST # remain part of a Pending Monograph because the approval for the application incorporating the TEST # sponsor's DMF has not been granted by FDA.

Section: Related compounds/TEST ##
No. of Commenters: 3
Comment Summary #1: Commenter requested correction of the concentration of the Standard solution concentration from 1 mg/mL to 2.0 µg/mL.
Response: Comment incorporated.
Comment Summary #2: Commenter requested clarification of the System suitability solution preparation by adding a System suitability stock solution prepared in methanol and System suitability solution in Diluent.
Response: Comment incorporated.
Comment Summary #3: Commenter requested changing the chemical names for USP Irinotecan Related Compound C RS and USP Irinotecan Related Compound D RS to preferred IUPAC names.
Response: Comment incorporated.
Expert Committee-initiated Change: The Expert Committee requested the visibility of the irinotecan peak under the system suitability be replaced by the signal to noise ratio to be more specific.
Expert Committee-initiated Change: The Expert Committee changed the USP Irinotecan Related Compound C RS from a trihydrate form to anhydrous form because the Irinotecan Related Compound C reference material received by USP is in anhydrous form.

Entries for the new associated USP Reference Standards and a Description and Solubility entry for Irinotecan Hydrochloride and are approved and will have the same official date as the monograph.

This Revision Bulletin supersedes the Authorized Irinotecan Hydrochlorde Pending Monograph that was published on the USP Pending Monographs web site. The Revision Bulletin will be incorporated in the First Supplement to the USP 33-NF 28 Reissue and the monograph will be in the redesign format at that time. USP also will post the redesigned monograph upon availability of the First Supplement, as well as retain the original, non-redesigned version with this Revision Bulletin.

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

Download the Irinotecan Hydrochloride Revision Bulletin  (153KB)
Download the Irinotecan Hydrochloride Description and Solubility  (84KB)
Download the Irinotecan Hydrochloride Reference Standards   (86KB)