Item | Specification |
Appearance | White or off-white crystalline powder |
Identification | IR, HPLC |
Water | ≤1.5% |
Related Substances | TOFA 06 ≤0.15% |
Tofacitinib trans isomer ≤0.15% | |
Tofacitinib dehydrogenated ≤0.15% | |
Each unknown impurity ≤0.10% | |
Total Impurities: ≤1.0% | |
Residual Solvents | Ethanol ≤5000ppm |
Benzene ≤2ppm | |
Toluene ≤890ppm | |
Chlroroethane ≤1000ppm | |
N,N-Dimethylformamide ≤800ppm | |
Palladium ≤10ppm | |
Dichloromethane ≤600ppm | |
Sulphated ash | ≤0.1% |
Heavy Metal | ≤10ppm |
Chrial HPLC | 3S, 4S tofacitinib ≤0.15% |
Assay (on anhydrous basis) 98.0-102.0% |