Item | Specification |
Appearance | White to off white crystalline powder |
Identification | UV, IR, HPLC |
Loss on drying | ≤0.5% |
Residue on ignition | ≤0.1% |
Heavy metals | ≤10ppm |
Related substances | P0Z1 ≤0.5% |
M1Z1 ≤0.5% | |
P0Z6 ≤0.5% | |
P0Z7 ≤0.5% | |
M2Z4 ≤0.5% | |
Any other impurity ≤0.2% | |
Total impurities ≤2.0% | |
Residual solvents | Ethanol ≤5000ppm |
Ethyl acetate ≤5000ppm | |
Triethylamine ≤5000ppm | |
Acetonitrile ≤410ppm | |
Dichloromethane ≤600ppm | |
Assay | 98.0%~102.0% (calculated on dried basis) |