Item | Specification |
Appearance | White or almost white powder |
Identification | IR, HPLC |
Voriconazole related compound C&D | Impurity C ≤0.2% |
Impurity D ≤0.1% | |
Any unknown impurity ≤0.1% | |
Total impurities ≤0.5% | |
Voriconazole related compound B | Impurity B ≤0.2% |
Voriconazole related compound F | Impurity F ≤0.1% |
Water (by K.F) | ≤0.4% |
Residue on ignition | ≤0.1% |
Assay (on the anhydrous and solvent-free basis, by HPLC) | 97.5%~102.0% |