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 percent), 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 percent 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, percent (determined on 0.5 g) |
BP |
Not more than 5.0 |
7 |
Assay by HPLC (as C10H11NaO3), percent |
BP |
94 - 102 (OAB) |
8 |
Impurity A: Impurities, percent (HPLC) |
BP |
Not more than 4.0 |
9 |
Unspecified impurities, percent (HPLC) |
BP |
Not more than 0.5 |
10 |
Sum of impurities other than A, percent (HPLC) |
BP |
Not more than 1.0 |
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