Check item | Standard Regulation | Test Result | ||
Appearance | Appearance | White to light yellow poeder | Almost white powder | |
Solubility | Freely soluble in ethyl acetate or DMF | Freely soluble in ethyl acetate or DMF | ||
Identification | HPLC | The retention time of the sanple solution corresponds to that of the standard solution,as obtained in the Assay | Complies | |
Analysis | Water | NMT. 1.0% | 0.089% | |
Organic impurities | Individual unspecified impurity NMT.0.20% | 0.044% | ||
Total impurities NMT1.0% | 0.083% | |||
Residual solven | Dichloromethane NMT.0.060% | 0.0094% | ||
Ethyl acetate NMT.0.50% | 0.0045% | |||
Terahydrofuran NMT.0.072% | Not detected | |||
Triethylamine NMT.0.50% | Not detected | |||
N-hexane NMT.0.029% | 0.00073% | |||
Toluene NMT.0.089% | 0.00045% | |||
DMF NMT.0.088% | Not detected | |||
Residue on ignition | NMT.0.20% | 0.085% | ||
Heavy | NMT.20ppm | Complies | ||
Assay | NLT98.0%and NMT102.0%of C22H17Cl2F6N3O3,calculated on the anhydrous basis | 99.7% |
1:Can I get some samples before bulk order?