Complaint
| Testing terms | Specifications | Results |
| Appearance | White or almost white,crystalline powder or colourless crystals; Freely soluble in water,sparingly soluble in ethanol(96%) | White crystalline powder;Freely soluble in water,sparingly soluble in ethanol |
| Identification | Corresponds | Corresponds |
| Melting point | 190°C | 190°C |
| Specific optical rotation | +20.5°-+21.5° | +20.9° |
| Clarity and color solution | Solution S is clear and not more intensely coloured than reference solution BY7 | Up to standard |
| Assay | 99.0%-100.5% | 99.7% |
| Copper | ≤5ppm | 0.07ppm |
| Iron | ≤2ppm | 0.10ppm |
| Impurity E(Oxalic acid) | ≤0.2% | <0.2% |
| Sulphated ash | ≤0.1% | 0.03% |
| Related substances | Impurity C: ≤0.15% Impurity D: ≤0.15% Unspecified impurities: ≤0.10% Sum of impurities(other than C and D)≤0.20% | < 0.01% < 0.01% ND ND |
| Residual solvent | Methanol ≤3000 ppm | 64 ppm |
