3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, 3-methyl 5-(2-methylpropyl) ester;
3-Isobutyl 5-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate [63675-72-9]
BRIEFING
Nisoldipine. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal for this drug substance which appeared in PF 43(6) [Nov.–Dec. 2017] has been canceled and is being replaced with a new proposal.
The liquid chromatographic procedures in the Assay and the test for Organic Impurities were validated using the Prodigy ODS 3 brand of column with L1 packing. The typical retention time for nisoldipine is about 15 min.
Description and solubility information: Nisoldipine is a yellow crystalline powder. It is soluble in ethanol and in methanol; practically insoluble in water.
(SM2: S. Ramakrishna)
Correspondence Number—C174748