Appearance
|
Yellow or light orange, crystalline powder
|
Conforms
|
Identification A
|
Infrared Absorption
|
Conforms
|
Identification B
|
Ultraviolet Absorption
|
Conforms
|
Loss on Drying
|
≤0.5%
|
0.1%
|
Residue on Ignition
|
≤0.1%
|
0.03% |
Heavy Metals
|
≤0.002%
|
Conforms
|
Limit of Isotretinoine
|
≤5.0%
|
0.05%
|
Assay
|
97.0%~103.0% (Calculated on dried basis)
|
99.9%
|