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Doxycycline Hyclate Delayed-Release Tablets

Type of Posting: Revision Bulletin

Posting Date: 31–May–2012

Official Date: 01–Jun–2012

Expert Committee: Monographs—Small Molecules 1

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 1 Expert Committee has revised the Doxycycline Hyclate Delayed-Release Tablets monograph. The purpose of the revision is to revise Dissolution Test 3 to accommodate a different strength and to incorporate style changes; and to add Dissolution Test 4 for a generic product approved by the FDA. The Standard solutions in the Assay and Organic Impurities test are revised for clarity.

The Doxycycline Hyclate Delayed-Release Tablets Revision Bulletin supersedes the currently official monograph and replaces the monograph in the Revision Bulletin posted on January 27, 2012, which became official on February 1 2012 and is being incorporated into the Second Supplement to USP 35-NF 30. The June 1 2012 Revision Bulletin will be incorporated in USP 36–NF 31.

Should you have any questions, please contact Ahalya Wise (301-816-8161 or aww@usp.org).