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异维A酸Isotretinoin/COA
|
Product Name |
Isotretinoin |
Batch No. |
20190723 |
|
MFG. Date |
2019.07.23 |
Exp Date |
2021.07.22 |
|
Quantity |
50 g |
Accord to |
USP38 |
|
ITEMS |
SPECIFICATIONS |
RESULTS |
|
|
Description |
Yellow or light orange,crystalline powder |
Complies |
|
|
Identification |
A:Infrared Absorption B:Ultraviolet Absorption |
Complies Complies |
|
|
Solubility |
Practically insoluble in water,soluble in methylene chloride,slightly soluble in alcohol |
Complies |
|
|
Related Substances |
Tretinoin ≤1.0% |
0.35% |
|
|
Organic volatile impurity |
Complies |
Complies |
|
|
Loss on drying |
≤0.5% |
0.1% |
|
|
Residue on ignition |
≤0.1% |
0.03% |
|
|
Residual Solvents |
Methanol≤3000ppm Ethyl Acetate≤5000ppm Hexane≤290ppm |
Complies Complies Complies |
|
|
Heavy metals |
＜0.002% |
＜0.002% |
|
|
Limit of Tretinoin |
≤1.0% |
0.15% |
|
|
Assay |
98.0%-102.0% |
99.69% |
|
|
Conclusion |
The product complies with USP38 |
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