No. | Test | Specification | Observations |
1. | Appearance | White or almost white, hygroscopic crystalline Powder | White, hygroscopic crystalline powder |
2. | Solubility | Freely Soluble in water, sparingly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. | Freely soluble in water, sparingly soluble insoluble in methylene chloride. |
3. | Identification | ||
B) IR | The infrared absorption spectrum of the sample should be concordant with the spectrum of methyl parahydroxybenzoate CRS. | Passes | |
D) Reaction of Solution | Passes the test | Passes | |
4. | Appearance of Solution | A 10 % w/v Solution in carbon dioxide-free water clear and not more intensely coloured than BY 6. (Determined on 5.0 gm) | Complies. |
5. | PH | 9.5 to 10.5 | 9.63 |
6. | Related substances by HPLC | Impurity A: Impurities: Not more than 3.0% | 1.79% |
Unspecified impurities: Not more than 0.5 % | Not Detected. | ||
Sum of impurities Other than A: not more than 1.0 % | No Detected. | ||
7. | Chloride | Maximum 350 ppm. | Less than 350 ppm |
8. | Sulphate | Maximum 300 ppm. | Less than 300 ppm |
9. | Heavy metals | Maximum 10 ppm. | Less than 10 ppm |
10. | Water | Maximum 5.0 % Determined on 0.500 gm. | 1.12 % |
11. | Assay by HPLC (as C8H7NaO3) | 95.0 % to 102.0 % | 97.17 % |
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