Quick Detail:
| Product name | Diltiazem hydrochlorid |
| Other name | Dilzem |
| CAS register number | 33286-22-5 |
| EINECS | 251-443-3 |
| Molecular formula | C22H27ClN2O4S |
| Molecular weight | 450.98 |
| Molecular structure |
 |
| Appearance | White crystalline powder |
| Melting point | 212-214 °C |
| Assay | 99% |
COA:
| Test | Analysis Standard | Results |
| Appearance | White to light yellow crystalline powder | White crystalline powder |
| Assay | ≥98.5%(Calculated on the dried basic) | 99.5% |
| Clarity of solution | The solution is clear | Complies |
| Optical rotation | +115-+120 | +116 |
| Identification | The light absorption exhibits a max uv236 | Complies |
| A blue colour is produced in the Chloroform layre | Complies | |
| The infrared absorption sprctrum is consistent with tthe reference spectrum | Complies | |
| The aqueous solution yields the reaction characteristic of chlorides | Complies | |
|
Residual Solvents, ppm |
Toluene≤800 | 330 |
| Acetone≤5000 | 3000 | |
| Ethanol≤5000 | 3300 | |
| Isopropanol≤5000 | Not detected | |
| Residue on ignition,% | ≤0.1 | 0.07 |
| Loss on drying ,% | ≤0.5 | 0.2 |
| Acidity pH | 4.3-4.6 | 4.4 |
| Heavy metal,ppm | ≤10 | Complies |
| Sulfate,% | ≤0.024 | 0.021 |
| Arsenic,% | ≤0.0002 | Complies |
| Related substances | The total impurities is not more than 0.5% | 0.41% |
| Conclusion | Comply with CP2010 | |
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