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Home Active Pharmaceutical Ingredients 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.

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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