Item
Specification
Test result
Description
Yellow
crystalline powder
Yellow crystalline
powder
Identification
The IR absorption
spectrum should correspond with reference spectrum
Complies
Should
exhibits maximum absorption at 352nm
Complies
Loss on drying
Not more than
0.5%
0.1%
Residue on
ignition
Not more than
0.1%
0.04%
Heavy metals
Not more than
0.002%
Less than
0.002%
Limit of
isotretinoin
Not more than
5.0%
0.1%
Assay
98.0%~102.0%( Calculated on the dried basis)
99.7%
Conclusion
It complies with all
the requirements of USP 40
