1 | Description | White crystalline powder. | A white or almost white, crystalline powder. |
2 | Solubility | Complies | Freely soluble in water and in ethanol |
3 | Identification A (By TLC test) | Complies | The principal spot in the chromatogram obtained with test solution (b) corresponds to that in the chromatogram obtained with reference solution (a). |
4 | Identification B (By Chemical test) | Complies | A violet-pink colour develops. |
5 | Appearance of solution | Complies | A 10.0% w/v solution is clear and not more intensely coloured than reference solutionYS7. |
6 | Fumaric acid | Less than 1.5% | NMT 1.5 % |
7 | Iron (Fe) | Less than 5ppm | NMT 5ppm |
8 | Heavy metals | Less than 10ppm | NMT 10ppm |
9 | Sulphated ash | 0.05% | NMT 0.1% |
10 | Water | 0.05% | NMT 2.0% |
11 | Assay | 99.7% | 99.0% - 101.0%(on anhydrous basis) |