产品展厅
产品展厅
Test Items | Specifications | Results |
Appearance | white to almost white crystalline powder | White crystalline powder |
Identification IR HPLC | Must conform to reference standard Must conform to reference standard | Conforms Conforms |
Absorbance | NMT0.02 | 0.008 |
Water | NMT 2.0% | 0.76% |
Residue on Ignition | NMT0.1% | 0.04% |
Heavy Metals | NMT 0.001% | ﹤0.001% |
Related compounds R-isomer Compound B Compound C Any other individual impurity Total impurities (excluding R-isomer) |
NMT 1.0% NMT 0.2% NMT 0.1% NMT 0.1% NMT 0.3% |
0.60% 0.03% Conforms 0.04% 0.15% |
Residual solvents Ethyl acetate Dichloromethane Methanol N,N-Dimethylformamidc |
NMT 0.5% NMT 0.06% NMT 0.3% NMT 0.088% |
0.20% Conforms Conforms 0.008% |
Assay (HPLC) | 98.0-102.0% | 99.4% |
Conclusion:It conforms to USP31. | ||
