1 | Description | White crystalline powder. Is odorless, and stable in air. | Colorless or translucent crystals or white,fine to granular,crystalline powder. Is odorless, and stable in air. |
2 | Solubility | Passes | Very soluble in water; freely soluble in alcohol and freely soluble in ethanol (96%) |
3 | Identification (By chemical test) | Complies | Solution should be strongly acid. |
4 | Identification (Tartrates) | Complies | Should give reactions of tartrates. |
5 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
6 | Assay (Dried substance) | 99.8% | 99.7% - 100.5% |
7 | Appearance of solution | Passes | Solution should be clear and not more intensely coloured than reference solution Y6. |
8 | Sulfated ash /Residue on ignition | 0.05% | NMT 0.1% |
9 | Oxalic acid | Less than 360ppm | NMT 360ppm |
10 | Chlorides | Less than 100ppm | NMT 100ppm |
11 | Sulfates | Less than 150ppm | NMT 150ppm |
12 | Calcium (Ca) | Less than 200ppm | NMT 200ppm |
13 | Specific optical rotation | +12.5° | +12.0° to +12.8° |
14 | Loss on drying | 0.1% | NMT 0.2% |
15 | Limit of Oxalate | Passes | No turbidity should produce. |