Product Description:
Items | Standard | Test Result |
Appearance | White crystals or crystalline powder | White crystalline powder |
Identification | Infrared absorption | Conform |
Assay | 98.5%~101.5% | 99.3% |
Residue on ignition | ≤0.4% | <0.06% |
Sulfate (SO4) | ≤0.03% | <0.03% |
Iron (Fe) | ≤30ppm | <30ppm |
Heavy metals (Pb) | ≤15ppm | <15ppm |
Related compounds | Not more than 0.5% of any individual impurity is found; Not more than 2.0% of total impurities is found | Conform |
Specific rotation [α]D25 | +5.7°~+6.8° | +5.9° |
Loss on drying | 8.0~12.0% | 11.1% |
Conclusion | This batch is conforming with the standard of USP39. |