Type of Posting: Notice of Intent to Revise
Posting Date: 28–Feb-2020, updated 28–Aug–2020*
Targeted Official Date: 01–Dec–2020, IRA
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 Telmisartan and Amlodipine Tablets monograph.
Comments were received that the impurity eluting at the relative retention time of 0.59 is incorrectly identified as Amlodipine Related Compound D (3-Ethyl 5-methyl 4-(2-chlorophenyl)-2-{[2-(1,3-dioxoisoindolin-2-yl)ethoxy]methyl}-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate). The purpose of the revision is to correct name of this impurity to Amlodipine Related Compound A (3-Ethyl 5-methyl [2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylate] fumarate). The relative response factor and acceptance criteria of the impurity eluting at the relative retention time of 0.59 remain unchanged.
The proposed revision was published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 46(3) [May – Jun. 2020] pursuant to the Rules and Procedures. The proposed IRA will become official on December 1, 2020 to allow this revision to align with the revisions published in Second Supplement to USP 43–NF 38.
Should you have any questions, please contact Donald Min, Senior Scientific Liaison (301–230–7457 or ddm@usp.org).
CN-20-036-01
*This Notice was updated on August 28, 2020 to revise the official date of the revision.