|
DILTIAZEM HYDROCHLORIDE |
| Product Name |
: |
Diltiazem Hydrochloride BP/EP/USP |
| Chemical Name |
: |
cis-(+)-[2-(2-dimethylaminoethyl)-5-(4-methoxyphenyl)-3-oxo-6-thia-2-azabicyclo[5.4.0]undeca-7,9,11-trien-4-yl]ethanoate |
| CAS Number |
: |
42399-41-7 |
| Chemical Formula |
: |
C22H26N2O4S |
| Molecular Mass |
: |
414.52 g/mol |
| Therapeutic Category |
: |
Antiemetic |
| Test |
Specification |
| Description |
White , odorless, crystalline powder or small crystals. It melts at about 210?C with decomposition. |
| Identification |
To be concordant with USP To comply with USP To comply with USP |
| Solubility |
Freely soluble in water, in formic acid, in methanol & in chloroform. sparingly soluble in dehydrated alcohol: insoluble in ether. |
| Heavy Metals |
NMT 20 ppm |
| Loss On Drying |
NMT 0.50% w/w |
| Assay on dried basis by HPLC |
NLT 98.50% NMT 101.50% w/w ofC22H26N2O4SHCI |
| Optical Rotation |
+110.0? to +116.0? |
| Related Substances by HPLC |
Unknown Individual Impurity NMT 0.10% Total impurities including desacetyl Diltiazem HCI. NMT 0.50% |
| Additional Tests |
A. Toluene NMT 750 ppm B. Methanol NMT 500 ppm C. Isopropyl Alcohol NMT 1000 ppm D. Ethyl Acetate NMT 500 ppm |
| Residue On Ignition |
NMT 0.10% w/w |
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