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% |
mode of transportation | ||
By Air | By Express | By Sea |
suitable for >50 | suitable for sampple order or <50 | suitable for >300 |
Fast:3-7 days | Fast:3-10 days | Fast: 7-45 days |
lower than the express cost | high shipping cost | lowest cost |