Items | Standards | Results |
Appearance | White crystals or crystalline powder | Conform |
Solubility | Freely soluble in acetic acid and water, Slightly soluble in methanol, very slightly soluble in ethanol, it dissolves in 0.1mol/L hydrochloric acid | Conform |
Melting point | 163~168°C | 164.9~165.4°C |
Specific rotation | +45~48° | +45.1° |
Identification | 1) The IR absorption spectrum of the sample is concordant with that of Voglibose reference standard AWS codes 2) NMR | Conform |
Acidity | 9.8 ~10.4 | 9.91 |
Total impurity | ≤0.2% | 0.08% |
Residual solvent Methanol Ethanol Dichloromethane | ≤0.3% ≤0.5% ≤0.06% | ND 0.1% ND |
Water | ≤0.2% | 0.11% |
Residue on ignition | ≤0.1% | 0.08% |
Heavy metals | ≤10ppm | ≤10ppm |
Assay (on dried basis) | ≥99.0% asme standards downloads | 99.9% free download codes |