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Specifications:
Sr.No. | Test | Specification |
1 | Description | Yellow, crystalline powder. Readily affected by exposure to light. |
2 | Solubility | Freely soluble in acetone, Sparingly soluble in ethanol. |
3 | Identification : By IR | The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained f with Nifedipine RS. |
4 | Heavy metals | Not more than 10 ppm |
5 | Sulphated ash | Not more than 0.1 % w/w |
6 | Loss on drying | Not more than 0.5 % w/w |
7 | Related substances (By HPLC) Nitrophenylpyridine analogue Nitrophenylpyridine analogue Total impurities | Not more than 0.20% Not more than 0.20% Not more than 0.50% |
8 | Assay By (Titrimetry) (on dried basis | Not less than 98.0 %w/w and not more than 102.0 %w/w |
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