Item | Specification |
Appearance | White to off white powder |
Identification | IR, HPLC |
Water content | NMT 0.5% |
Residue on ignition | NMT 0.1% |
Heavy metal | NMT 20ppm |
Palladium content | NMT 20ppm |
Optical isomer | NTM 0.5% |
Related substance | Z-168*: NMT 0.15% |
SC03610*: NMT 0.15% | |
Any other unknown impurity: NMT 0.10% | |
Total impurity: NMT 0.5% | |
2-(2-aminothianzol-4-yl) acetic acid | NMT 0.1% |
Residual solvent | Methanol: NMT 0.3% |
Ethyl acetate: NMT 0.5% | |
THF: NMT 0.072% | |
Benzene: NMT 0.0002% | |
Toluene: NMT 0.089% | |
Assay | 98.0% - 102.0% |
PSD | D (0.5): 10μm - 30μm |
D (0.9): 20μm - 80μm |