1 | Description | Faintly yellowish-white, odorless powder. | White to faintly yellowish-white, odorless crystals or powder. |
2 | Solubility | Complies | Freely soluble in water. |
3 | Identification (By Chemical test) | Complies | The mixture turns bright yellow and becomes clear. |
4 | Assay | 99.8% | 99.0% - 100.5% on the dries basis |
5 | Residue on ignition | 0.02% | NMT 0.1% |
6 | Absence of reducing substances | Complies | The color of the solution does not change. |
7 | Completeness and color of solution | 0.021 | Absorbance should NMT 0.030 |
8 | Loss on drying | 0.3% | NMT 1.0% |
9 | Melting range or Temperature | 128.8° - 129.5° | 128° - 132° |
10 | Optical Rotation | -16.5° | -15.7° to -17.3° |