Amlodipin Besylate

Amlodipin Besylate

Specification	For : Amlodipine Besilate BP
Test	Specification
Description	White or almost white powder
Identification	A) Infrared Absorption spectrophotometry B) TLC C) Specific Absorbance Max 360 nm 113-121
Solubility	Slightly soluble in water, freely soluble in Methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol.
Optical Rotation	- 0.10 0 to + 0. 10 0
Related Substance by 1) TLC 2) Liquid chromatography a. Impurity D b. Other Impurities	It should complies as prescribed test a. Max. 0.3% b. Max. 0.3%
Water	Limit: Max. 0.5%
Sulphated Ash	Limit : Max. 0.2%
Assay (Anhydrous basis)	Limit: 97% to 102%