Sunitinib malate 341031-54-7 99%
TEST ITEM |
SPECIFICATION |
RESULTS |
|
Appearance |
Yellow to brown crystalline powder |
Yellow crystalline powder |
|
Identification |
FT-IR、HPLC、NMR、Mass |
Confirm |
|
Melting Point |
187ºC-192ºC |
189.6ºC |
|
Water |
≦3.0% |
0.3% |
|
Residual Solvent (Meets the requirements of ICH) |
|
||
Ethyl Acetate |
≦5000ppm |
28ppm |
|
Acetone |
≦5000ppm |
1120ppm |
|
N,N-Dimethylformamide |
≦880ppm |
218ppm |
|
Methanol |
≦3000ppm |
1021ppm |
|
Residue on Ignition |
≦0.2% |
0.08% |
|
Heavy Metals |
≦20 ppm |
9ppm |
|
IMPURITIES: |
|
||
single impurity |
≦0.5% |
0.24%max |
|
Total Impurities |
≦1.0% |
0.34% |
|
Assay (HPLC) |
98.0%-102.0% |
99.7% |
|
TEST ITEM |
SPECIFICATION |
RESULTS |
|
Appearance |
Yellow to brown crystalline powder |
Yellow crystalline powder |
|
Identification |
FT-IR、HPLC、NMR、Mass |
Confirm |
|
Melting Point |
187ºC-192ºC |
189.6ºC |
|
Water |
≦3.0% |
0.3% |
|
Residual Solvent (Meets the requirements of ICH) |
|
||
Ethyl Acetate |
≦5000ppm |
28ppm |
|
Acetone |
≦5000ppm |
1120ppm |
|
N,N-Dimethylformamide |
≦880ppm |
218ppm |
|
Methanol |
≦3000ppm |
1021ppm |
|
Residue on Ignition |
≦0.2% |
0.08% |
|
Heavy Metals |
≦20 ppm |
9ppm |
|
IMPURITIES: |
|
||
single impurity |
≦0.5% |
0.24%max |
|
Total Impurities |
≦1.0% |
0.34% |
|
Assay (HPLC) |
98.0%-102.0% |
99.7% |
|
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