Amlodipine Besilate

CAS number: 111470-99-6

Molecular formula:

molecular weight:

Chemical structure:

Sr No.TestSpecificationResult
1DescriptionWhite or almost White powder.Almost white Powder
2SolubiltySlightly soluble in water , Freely soluble in methanol, sparingly   soluble in alcohol , slightly soluble in 2-propanolComplies
3Identification
i) IRi) The infrared absorption spectrum of the   substances being examined in mulls should be concordant with the spectrum   Obtained form Amlodipine Besilate Working standardComplies
Ii) By HPLCii) The retention of major peak in the chromatogram of the assay   preparation corresponds to that in the chromatogram of the standard   preparation as Obtained in the Assay.Complies
4Optical Rotation-0.100   to +0.1000.000
5WaterNot more than 0.50 % w/w0.19%
6Residue on ignitionNot more than 0.20 % w/w0.03%

Related Substances By TLCAny spot obtained from the test solution Except for the principal   spot is not greater than the spot obtained from Standard solution 1 (0.3 %)   and at most two spots are more intense than the spot Obtained from standard   solution 2(0.1%)Complies
7Related Substances By HPLC
Amlodipine Impurity ANot more than 0.30 %0.02%
Total of other ImpuritiesNot more than 0.30 %0.18%
8Assay By HPLC On anhydrous basisNot less than 97.0 % w/w and Not more than 102.0 % w/w on   anhydrous basis99.69%
9Microbial test (CFU/g)
a. Aerobic MicroorganismNot more than 1000 cfu/gmLess than 10 cfu/gm
b. Mold & YeastsNot more than 100 cfu/gmLess than 10 cfu/gm
Pathogens

i) E.coliAbsentAbsent
ii) SalmonellaAbsentAbsent
iii) S.aureusAbsentAbsent
iv) Pesudomonas aeruginosaAbsentAbsent
10Heavy metalsNot more than 0.002 %Less than 0.002 %
11Residual Solvents By HSGC
MethanolNot more than 3000 ppm803.66 ppm
Ethyl acetateNot more than 5000 ppm374.19 ppm
TolueneNot more than 890 ppmNot detected