Type of Posting: Notice of Intent to Revise
Posting Date: 10–Apr–2017
Targeted Official Date: 01–May–2017, Revision Bulletin
Expert Committee: Chemical Medicines Monographs 1
In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines Monographs 1 Expert Committee intends to revise the Doxycycline Hyclate Capsules and Doxycycline Hyclate Tablets monographs.
Based on comments received, the Expert Committee proposes to widen the limit for 4-epidoxycycline in the test for Organic Impurities from NMT 0.5% to 1.0% to accommodate a sponsor’s FDA-approved specification.
It is anticipated that a Revision Bulletin for Doxycycline Hyclate Capsules and Doxycycline Hyclate Tablets will be posted on April 28, 2017 and become official on May 1, 2017.
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