1 | Description | White crystalline powder | White crystalline powder. |
2 | Solubility | Passes | Freely soluble in water and in alcohol. |
3 | Identification A (By pH) | Complies | The pH of the solution is less than 2. |
4 | Identification B (By TLC test) | Complies | The principal spot in the chromatogram obtained with test solution (b) is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a). |
5 | Identification C (By Chemical test) | Complies | A violet-pink colour develops. |
6 | Appearance of solution | Complies | Solution S is clear and not more intensely coloured than reference solution Y7. |
7 | Fumaric acid | NMT 1.5% | NMT 1.5% |
8 | Iron (Fe) | NMT 5ppm | NMT 5ppm |
9 | Heavy metals | NMT 10ppm | NMT 10ppm |
10 | Sulphated ash | 0.06% | NMT 0.1% |
11 | Water | 0.21% | NMT 2.0% |
12 | Assay | 99.43% | 99.0% - 101.0% on anhydrous basis |