Specifications of Amlodipine Besylate [BP/EP]

Synonyms of Amlodipine Besylate : Amlodipine; amlodipine besylate; Norvasc; (RS)-3-ethyl-5-methyl-2-(2- aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate;
Formula of Amlodipine Besylate : C26H31ClN2O8S
CAS RN of Amlodipine Besylate : 88150-42-9 ; 111470-99-6
ACX No. of Amlodipine Besylate : X1004356-4
Uses of Amlodipine Besylate : Antianginal , Antihypertensive.
Specification of Amlodipine Besylate : As per BP/EP
Impurity Profile of Amlodipine Besylate :

By HPLC

Impurity D : -ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate. 0.3 %
Total of other impurities 0.3%

By TLC

Any impurities. In the chromatogram obtained with reference solution (a):- Any impurity : any spot ,apart from the principal 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%)