|
Testing items |
Specifications |
Results |
|
Description |
Yellow crystalline powder |
Complies |
|
Identification |
The IR absorption spectrum should correspond with reference spectrum |
Complies |
|
Should exhibits maximum absorption |
Complies |
|
|
Organic volatile impurity |
Complies |
Complies |
|
Heavy metals |
≤20ppm |
<20ppm |
|
Loss on drying |
≤0.50% |
0.01% |
|
Residue on ignition |
≤0.10% |
0.03% |
|
Related substances |
≤0.50% |
0.23% |
|
Limit of isotretinoin |
≤1.00% |
0.10% |
|
Assay (HPLC) |
98.0~102.0% |
99.0% |
|
Conclusion: The Product Conforms to USP.
|
||
