Lapatinib ditosylate CAS NO.388082-78-8

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%