TYPICAL PROPERTIES:
CHARACTERS:
Sr. no. | Characteristic | Test Method | Specification |
1 | Appearance | Visual | White or almost white hygroscopic crystalline powder |
2 | Solubility | BP | Freely Soluble in water, sparingly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. |
IDENTIFICATION (as per BP / Ph. Eur.):
Ref. alphabet | Identification | Test Method | Specification |
B | Infrared absorption | BP | Matches with standard |
D | Reaction of sodium salt | BP | To comply with the monograph |
TESTS:
Sr. no. | Test | Test Method | Specification |
1 | Appearance of solution | BP | A 10 % w/v solution in carbon dioxide-free water clear and not more intensely coloured than BY 6. (Determined on 5.0 gm) |
2 | pH | BP | 9.5 10.5 |
3 | Chloride, ppm | BP | Not more than 350 |
4 | Sulphate, ppm | BP | Not more than 300 |
5 | Heavy metals, ppm | BP | Not more than 10 |
6 | Water, % (determined on 0.5 g) | BP | Not more than 5.0 |
7 | Assay by HPLC (as C10H11NaO3), % | BP | 94 102 (OAB) |
8 | Impurity A: Impurities, % (HPLC) | BP | Not more than 4.0 |
9 | Unspecified impurities, % (HPLC) | BP | Not more than 0.5 |
10 | Sum of impurities other than A, % (HPLC) | BP | Not more than 1.0 |
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