1 | Appearance | Almost white crystalline powder. | White or almost white crystalline powder. |
2 | Solubility | Complies | Freely soluble in water and in alcohol and sparingly soluble in acetone. |
3 | Identification A (By Melting point) | 132.0°C | 128.0°C - 132.0°C |
4 | Identification B (By IR) | Complies | IR spectra of the sample should be concomittant with IR spectra of the standard. |
5 | Appearance of Solution | Complies | Clear and colourless solution |
6 | Optical Rotation | +0.01° | -0.10° to + 0.10° |
7 | Water insoluble substances | 0.002% | NMT 0.1% |
8 | Related substances: Impurity A (Fumaric acid) | 0.7% | NMT 1.0 % |
9 | Related substances: Impurity B (Maleic acid) | 0.014% | NMT 0.05% |
10 | Related substances: Any other impurity | Not detected | NMT 0.1% |
11 | Related substances: Total impurity | Not detected | NMT 0.5% |
12 | Water | 0.2% | NMT 2.0% |
13 | Sulphated ash | 0.04% | NMT 0.1% |
14 | Assay (anhydrous substance) | 99.8% | 99.0% to 101.0% |