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Test |
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Specification |
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Description |
: |
A White to off-white crystalline powder |
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Solubility |
: |
Sparingly soluble in dichloromethane, slightly soluble in methanol, practically insoluble in water |
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Identification
By infrared Absorption
|
: |
The infrared absorption spectrum of the sample should be is concordant with the spectrum obtained from Telmisartan working standard |
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Appearance of solution |
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A 5% solution in sodium hydroxide is not more intensly coloured than reference solution YS4 |
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Related Substances by HPLC
a) Highest Individual impurity
b) Total impurities |
: |
Not more than0.2% w/w
Not more than 1.0% w/w |
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Loss on Drying |
: |
Not more than 0. 50 % w/w |
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Sulphated Ash |
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Not more than 0.10 % w/w |
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Heavy Metals |
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Not more than 20 ppm |
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Assay (on dried basis) |
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Not less than 98.0% and Not more than 102.0% w/w |
