Type of Posting: Notice of Intent to Revise
Posting Date: 27–May–2020
Targeted Official Date: To be determined, In Process Revision
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 Amantadine Hydrochloride monograph.
Comments were received indicating that the specifications for Related Compound A and Related Compound B in the test for Organic impurities may pose safety concerns. The Expert Committee proposes to revise the acceptance criteria for Related Compound A and Related Compound B from NMT 0.3% to NMT 0.15%.
It is anticipated that the proposed revision will be published in the future as an In-process Revision in Pharmacopeial Forum (PF) pursuant to Section 7.02 of the Rules and Procedures.
Should you have any questions, please contact Shankari Shivaprasad, Senior Scientific Liaison to the Chemical Medicines Monographs 1 Expert Committee (301–230–7426 or email@example.com).