|
Testing items |
Specifications |
Results |
|
Description |
Yellow or light orange crystalline powder |
Conforms |
|
Identification |
The IR absorption spectrum should correspond with reference spectrum |
Conforms |
|
Should exhibits maximum absorption at 352nm |
Conforms |
|
|
Heavy metals |
≤20ppm |
<20ppm |
|
Loss on drying |
≤0.50% |
0.1% |
|
Residue on ignition |
≤0.10% |
0.04% |
|
Limit of isotretinoin |
≤5.00% |
0.06% |
|
Assay (HPLC) |
97.0~103.0% |
99.9% |
|
Conclusion: The Product Conforms to USP/CP.
|
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