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Mesalamine Delayed-Release Tablets

Type of Posting: Notice of Intent to Revise
Posting Date: 30-Jul-2021
Targeted Official Date: 01-Jul-2022; Interim Revision Announcement
Expert Committee: Small Molecules 2

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Mesalamine Delayed-Release Tablets monograph.

Comments with supporting data were received that indicate the dissolution conditions in Dissolution Test 3 do not adequately maintain the target pH. The Expert Committee proposes to revise the Mesalamine Delayed-Release Tablets, Dissolution Test 3 to increase the buffer concentration of the Medium in Buffer stage 1 and Buffer stage 2 to adequately maintain the target pH. Additionally, the Times in Buffer stage 2 are proposed to be revised for consistency with what has been approved.

It is anticipated that the proposed revisions will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 48(1) [Jan. – Feb. 2022] pursuant to the Rules and Procedures. The comment period for this revision ends on March 31, 2022. In the absence of any significant adverse comments, the proposed IRA will become official on July 1, 2022.

Should you have any questions or comments, please contact Tsion Bililign, Senior Scientist II (