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DESCRIPTION
Product Name	Amlodipine Base/Besylate BP/EP/USP
CAS Number	88150-42-9
Chemical Formula	C20H25ClN2O5
Molecular Mass	408.88 g/mol

Specification of Amlodipine Base/Besylate
abc	A white or almost white powder
Solubility	Slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol
Identification	The IR spectrum of sample is concordant with working standard spectrum. The solution shows absorption maximum at 360 nm.
Optical Rotation	-0.1° to +0.1°

Test
Water content by KF	NMT 0.5 % w/w
Sulphated Ash	NMT 0.2 % w/w
Related substances (by HPLC)	Impurities D NMT 0.3 % All impurities other than impurity D NMT 0.3 %
Related substances (by TLC )	Total Impurities NMT 0.3 % Individual impurity NMT 0.1 %