Lapatinib ditosylate 388082-77-7 388082-77-7
Test |
Specification |
conclusion |
Characteristics |
Pale yellow or yellow crystalline powder |
conforms
|
Identification a) IR b) HPLC |
a)IR chromatograph Conforms to the characteristic peak of R.S. b)The retention time of the major peak in the chromatogram Conforms to the characteristic peak of R.S. |
conforms
|
Residue on ignition |
Not more than 0.5% |
0.2% |
Loss on drying |
Not more than 1.0% |
0.5% |
Heavy Metals |
Not more than 20 ppm |
conforms |
Related substance Total impurities |
Not more than 1.0% |
0.80% |
Assay |
99.0%-101.5% |
99.1% |
Test |
Specification |
conclusion |
Characteristics |
Pale yellow or yellow crystalline powder |
conforms
|
Identification a) IR b) HPLC |
a)IR chromatograph Conforms to the characteristic peak of R.S. b)The retention time of the major peak in the chromatogram Conforms to the characteristic peak of R.S. |
conforms
|
Residue on ignition |
Not more than 0.5% |
0.2% |
Loss on drying |
Not more than 1.0% |
0.5% |
Heavy Metals |
Not more than 20 ppm |
conforms |
Related substance Total impurities |
Not more than 1.0% |
0.80% |
Assay |
99.0%-101.5% |
99.1% |
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