Short Description:
Diltiazem hydrochloride
CAS Number: 33286-22-5
Molecular Formula: C22H27ClN2O4S
Standard: USP32
Package: 25kg/drum
Description:
Diltiazem hydrochloride
CAS Number: 33286-22-5
Molecular Formula: C22H27ClN2O4S
Standard: USP32
Package: 25kg/drum
| ITEMS | LIMIT |
| Appearance | A White Crystalline powder |
| Identification | A: Infrared Absorption |
| B: The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, obtained as directed in the Assay | |
| C: It responds to the test for Chloride | |
| Specific rotation | +1100～～ +1160 |
| Loss on drying | ≤0.5% |
| Residue on ignition | ≤0.1% |
| Heavy Metals | ≤20ppm |
| Organic Volatile impurities | Should meet the requirements |
| (Method IV ) | |
| Related compounds | DESACETYL DILTIAZEM HCL ≤0.5% |
| Other single impurity ≤0.5% | |
| Total impurities ≤1.0% | |
| Assay | C22H26N2O4S.HCL: 98.5%-101.5% (On the dried basis) |
