Product:  Diltiazem hydrochloride   C₂₂H₂₅N₂O₄S, HCl 

Test

Limits

 Description

Solubility

Identification

Specific rotation

Related substances HPLC

Loss on drying

Heavy metals

 Residue on ignition

Organic volatile impurities

ASSAY

 A white or almost white, crystalline powder or small crystals.

 Freely soluble in chloroform, formic acid, methanol, and water, sparingly soluble in dehydrated alcohol, insoluble in ether. It melts at about 210°C with decomposition

A.       Infrared spectrophotometry, as same as Diltiazem hydrochloride RS.

B.       The retention time of the principal peak in the chromatogram obtained with test and standard are the same

C.       Chloride positive

+110° - +116°

The area of any peak apart from the principle peak is not grater than 0.5%, the sum of such area not grater than 1.0%.

Not more than 0.5 per cent,

Not more than 20 ppm.

Not more than 0.1 per cent.

Meets the requirements.

98.5 - 101.5 % w/w calculated with reference to the dried substance.

This material has been prepared following the good manufacturing practice (G.M.P.) and conforms above specification & requirements of BP2000