AMLODIPINE BESILATE BP/EP
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SPECIFICATION OF AMLODIPINE BESILATE(BP, EP)
SR. NO TEST SPECIFICATION
1 Description White or almost White Powder.
2 Solubility Freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water, slightly soluble in 2- propanol.
3 Identification 1. Examine the chromatograms obtain in test A for related substances in U. V. light 366nm. Results. the principal spot in the chromatogram obtain with test solution (b) is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (b) 2. IR absorption spectophotometry(2.2.24) . comparision :amlodipine besilate CRS.3. 0.005% Solution of test in 1% v/v solution of 0.1%M HCL in methanol R. Examined between 300 nm to 400 nm. (2.2.25) The solution shows an absorption maximum at 360 nm. The specific absorbance at maximum is 113 to 121.
4 Optical Rotation -0.100 to +0.100
5 Sulphated Ash Not more then 0.2 % w/w
6 Related SubstancesA. by TLC B. by HPLC In the chromatogram obtained with reference solution (a) :-Any impurity : any spot , apart from the princilal spot, is not more intense than the spot in the chromatogram obtained with reference solution (c) (0,3%) and at most 2 spots are more intense than the spot in the chromatogram obtained with reference solution (d) (0.1%) Impurity D : Not more than 0.3%Total of other impurity : Not more than 0.3%
7 Water Not more than 0.5 % w/w
8. Assay Not less than 97.0 % w/w and not more than 102.0% w/w on anhydrous basis