Type of Posting: Notice of Intent to Revise
Posting Date: 20–Jul–2018
Targeted Official Date: 01–Aug–2018, Revision Bulletin
Expert Committee: Chemical Medicines Monographs 6
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 6 Expert Committee intends to revise the Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets monograph.
The Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets monograph was recently revised to add Dissolution Test 7 via a Revision Bulletin that was published on June 29, 2018 and became official on July 1, 2018. Two transcription errors were subsequently discovered in this Revision Bulletin under the Times subsection for Pseudoephedrine Hydrochloride and Standard stock solution A. The Times subsection for Pseudoephedrine Hydrochloride should be “45 min, 3, 5, and 12 h” as shown in Table 8. In addition, the amount of methanol in the Standard stock solution A should be NMT 5% rather than NMT 0.5%.
It is anticipated that a Revision Bulletin will be published on July 27, 2018 and become official on August 1, 2018, which will contain revisions to Dissolution Test 7, pursuant to section 7.02 of the Rules and Procedures.
Should you have any questions, please contact Richard Nguyen, Associate Scientific Liaison (301–816–8170 or firstname.lastname@example.org) or Tsion Bililign, Scientific Liaison (301-816-8286 or email@example.com).