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Test |
Limits |
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Description
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A white or almost white, crystalline powder or small crystals.
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Solubility
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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
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Identification
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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
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Specific rotation
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+110° - +116°
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Related substances HPLC
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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%.
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Loss on drying
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Not more than 0.5 per cent,
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Heavy metals
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Not more than 20 ppm.
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Residue on ignition
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Not more than 0.1 per cent.
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Organic volatile impurities
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Meets the requirements.
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ASSAY
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98.5 - 101.5 % w/w calculated with reference to the dried substance.
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