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1 Gram |
Negotiable |
Regorafenib Monohydrate Regorafenib monohydrate (BAY 73-4506) Regorafenib API
Items |
Specifications |
Results |
Appearance |
White to off-white powder |
Conforms |
Identification |
The retention time of the main peak obtained from the sample is within 5% of the reference sample. |
Conforms |
Solubility |
Solubility in DMSO and THF sligtly soluble in MeOH,insoluble in H2O |
Solubility in DMSO and THF sligtly soluble in MeOH,insoluble in H2O |
Loss on drying |
NMT 0.5% |
0.16% |
Residue on Ignition |
NMT 0.1% |
0.01% |
Heavy metal |
NMT20ppm |
Conforms |
Rapid moisture |
NMT 1.0% |
0.42% |
Related Substance |
Any Single impurity: NMT 0.5% |
0.20% |
|
Total Impurity: NMT 1.0% |
0.24% |
Purity |
NLT 99.0% |
99.76% |
Assay |
98.5%~102.5% |
99.37% |
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