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Telmisartan and Amlodipine Tablets

Type of Posting: Notice of Intent to Revise
Posting Date: 28–Feb-2020
Targeted Official Date: 01–Nov–2020, IRA 
Expert Committee: Chemical Medicines Monographs 2

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 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. 

It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 46(3) [May – Jun. 2020] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on July 31, 2020. In the absence of any adverse comments the proposed IRA will become official on November 1, 2020. 

Should you have any questions, please contact Donald Min, Senior Scientific Liaison (301–230–7457 or