Donepezil Hydrochloride

Type of Posting: 
Revision Bulletin
Posting Date: 
29–Apr–2011
Official Date: 
01–May–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 monograph.

Using a flexible monograph approach, an Organic Impurities Procedure 2 is added 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.

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.

A different polymorphic form of the drug substance, namely monohydrate form, is added to the monograph. The test for Water Determination is revised by adding a limit of NMT 7.0% that applies to the monohydrate form. The IR identification test A is modified by including a procedure for polymorphic equalization.

This Donepezil Hydrochloride Revision Bulletin supersedes the currently official Donepezil Hydrochloride monograph and replaces the monograph in USP 34–NF 29, which was scheduled to become official on May 1, 2011. The Revision Bulletin will be incorporated in USP 35–NF 30.

Should you have any questions, please contact Hari Ramanathan (301-816-8313 or hr@usp.org).