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Notice of Intent to Revise: Benztropine Mesylate

Type of Posting: Notice of Intent to Revise
Posting Date: 30-Apr-2021
Targeted Official Date: 01-Jul-2021; Revision Bulletin
Expert Committee: Small Molecules 4

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the Benztropine Mesylate monograph.

Comments with supporting data were received that indicate the acceptance criteria in the test for Organic Impurities to be official on May 1, 2021 may not be applicable to all approved products. The Expert Committee proposes to widen the acceptance criteria for benztropine related compound A from NMT 0.10% to NMT 0.3% in the test for Organic Impurities to accommodate FDA approved specifications.

It is anticipated that the proposed revision will be published as a Revision Bulletin on June 25, 2021 pursuant to the Rules and Procedures. 

Should you have any questions, please contact Claire Chisolm, Senior Scientist II (