AMLODIPINE BESYLATE
CAS NO.111470-99-6
M.F:C20H25ClN2O5·C6H6O3S
Shelf life:4 years
The detailed specifications are as below:
| Items | Standard |
| Appearance | White or almost white powder |
| Identification | A. Infrared Absorption:The IR spectrum of the sample corresponds to the IR spectrum of the RS |
| B. Identity Test:The retention time of the Assay preparation corresponds to the Standard preparation | |
| Optical rotation | -0.10°~+0.10° |
| Water Determination | Not more than 0.5% |
| Residue on ignition | Not more than 0.2% |
| Related substances(HPLC) | Related compound A NMT 0.3% |
| Other than benzenesulfonic and related compound A ,the total of other impurities NMT 0.3% | |
| Related substances(TLC) | Any spot obtained from the test solution is not greater in size than the spot obtained from standard solution(0.3%) |
| At most two spots are more intense than the spot obtained from standard solution(0.1 %) | |
| Residual Solvents | Not more than 5000ppm of Ethanol |
| Assay | Calculate on anhydrous, it contains not less than 97.0% and not more than 102.0% of C26H31ClN2O8S |