| Function: | Anti Hypertension, Angina Pectoris |
|---|---|
| Certification: | / |
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
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Audited Supplier | 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 |
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