Isotretinoin

Items

Standards

Results

Appearance

Yellow crystals

Yellow crystals

Soluble in trichloromethane, sparingly solube in ethanol, isopropanol and polyethylene glycol, practically insoluble in water

conforms

Identification

IR: the infrared absorbance spectrum is concordant with the reference standard spectrum

Conforms

UV:Absorptivities at 354nm do not differ by more than 3.0%(calculated on the dried basis)

0.5%

Loss on drying

NMT0.5%

0.13%

Residue on lgnition

NMT0.1%

0.05%

Heavy Metal

NMT0.002%

<0.002%

Limit of tretinoin

NMT1.0%

0.13%

Residual solvents

Ethanol ≤5000ppm

1349ppm

Purity(HPLC)

Calculated on the dried basis

99.3%