China Factory Outlets Amlodipine Besylate CAS No 111470-99-6, Find details about China Amlodipine Besylate, 111470-99-6 from Factory Outlets Amlodipine Besylate CAS No 111470-99-6
Items | Spectfication | Analytical results |
Characteristic | ||
Appearance | White or almost white powder | Almost white powder |
Identification | ||
A.Infrared absorption | The IR spectrum of the sample corresponds to the IR spectrum of the RS | 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 | The retention time of the assay preparation corresponds to the standard preparation |
Tests | ||
Optical rotation | -0.10°~+0.10° | -0.003° |
Water determination | Not more than 0.5% | 0.1% |
Residue on ignition | Not more than 0.2% | 0.05% |
Related substances(HPLC) | Related compound A NMT 0.3% | Less than 0.03% |
Other than benzenesulfonic and related compound A,the total of other impurities NMT 0.3% | Less than 0.03% | |
Related substances(TLC) | Any spot obtained from the test solution is not greater in size than the spot obtained from standard solution(0.3%) | ND |
At most two spots are more intense than the spot obtained from standard solution(0.1%) | ND | |
Residual solvents | Not more than 5000ppm of ethanol | ND |
Assay | Calculate on anhydrous,it contains not less than 97.0% and not more than 102.0% of C26H31ClN2O8S | 100.2% |
ACCORDING TO | USP 43 |