Posting Date: 29–Jul–2011
Official Date: 01–Aug–2011
Expert Committee: Monographs—Small Molecules 4
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Donepezil Hydrochloride Tablets monograph. The purpose of the revision is to accommodate the sponsor’s FDA approved specifications as follows:
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Widen the Assay acceptance criteria from 93.0%–107.0% to 90.0%–110.0% and clarify sample solution preparation.
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Using a flexible monograph approach, add an Organic Impurities Procedure 2 to the monograph to capture potential impurities from a different synthetic route. A note is added to specify that the currently official Organic Impurity procedure is now designated as Procedure 1 and Organic impurities, Procedure 2 is recommended if any of the impurities included in Table 3 are potential related compounds.
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This newly added liquid chromatographic procedure was previously published on the USP Pending Monographs Web site as a part of the Authorized Pending Monograph. It is based on analyses performed with the Kromasil C-18 brand of L1 column. The typical retention time of donepezil peak is between 12.5 min and 15.5 min, depending on the gradient delay time.
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- Designate the current analytical procedure under Dissolution as a chromatographic method. Add an alternate spectrometric procedure to calculate the percentage of the labeled amount of donepezil hydrochloride dissolved.
- Add Labeling section to state with which Organic impurities procedure the article complies.
This Donepezil Hydrochloride Tablets Revision Bulletin supersedes the currently official Donepezil Hydrochloride Tablets monograph and replaces the monograph in USP 34–NF 29, First Supplement, which was scheduled to become official on August 1, 2011. The Revision Bulletin will be incorporated in USP 35–NF 30, First Supplement.
Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330 or rr@usp.org).