ITEMS

SPECIFICATION

RESULTS

Appearance

Yellow to light-orange powder

Yellow powder

Identification

The IR absorption spectrum should correspond

with reference spectrum

Correspond

with reference spectrum

Should exhibits maximum absorption at 352nm

Exhibits maximum absorption

at 352nm

Loss on drying

Not more than 0.5%

0.18%

Residue on ignition

Not more than 0.1%

0.02%

Heavy metals

Not more than 0.002%

Less than 0.002%

Limit of Isotretinoin

Not more than 5.0%

0.08%

Related Substances

Not more than 0.5%

0.17%

Assay

97.0%~103.0 %( Calculated on the dried basis)

99.70%

Organic volatile impurity

Methanol ≤ 3000ppm

20ppm

Ethyl Acetate ≤5000ppm

650ppm

Isopropanol ≤5000ppm

35ppm

Conclusion: The drug superscript meets standards of USP40 STANDARD