Name: Felodipine
Synonyms: 4-(2,3-Dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinecarboxylic acid ethyl methyl ester; Plendil
Molecular Formula: C18H19Cl2NO4
Molecular Weight: 384.26
CAS Registry Number:72509-76-3
Appearance
Light yellow to yellow, crystalline powder.
Freely soluble in acetone and in methanol;
very slightly soluble in heptane; insoluble in
water .
Loss on drying
Dry it at 105 ° C for 3 hours: it loses not more
than 0.5% of its weight .
Residue on ignition NMT 0.1%
Heavy metals NMT 0.002%
Chromatographic purity
Any individual impurity: NMT 1.0%;
Sum of all impurities: NMT 1.5%
Residual solvents
Ethanol: NMT 0.5%( LOD method )
Isopropyl ether: NMT 0.3%( LOD method )
Toluene: NMT 890ppm ( GC method )
Assay
Felodipine contains not less than 98.0 percent
and not more than 101.0 percent if
C 18 H 19 Cl 2 NO 4 , calculated on the dried basis .
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