1 | Description | Almost white, crystalline powder. | A white or almost white, crystalline powder |
2 | Solubility | Complies | Freely soluble in water and in alcohol. |
3 | Identification A (By pH) | 1.12 | The pH of the solution should be less than 2. |
4 | Identification B (By TLC test) | Complies | The principal spot in the chromatogram obtained with test solution (b) should be 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 color should develop. |
6 | Appearance of solution | Complies | Solution should be clear and not more intensely colored than reference solution Y7. |
7 | Fumaric acid | Less than 1.5% | NMT 1.5% |
8 | Iron (Fe) | Less than 5 ppm | NMT 5ppm |
9 | Sulfated ash | 0.04% | NMT 0.1% |
10 | Water | 0.3% | NMT 2.0% |
11 | Assay (anhydrous basis) | 99.8% | 99.0% - 101.0% |