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維A酸原料粉末Tretinoin產品質量報告單2020質檢
CERTIFICATE OF ANALYSIS
|
Product Name |
Retinoic acid (tretinoin) |
Batch No. |
180820 |
|
MFG. Date |
2018.08.20 |
Exp. Date |
2018.08.20 |
|
QTY |
15kg |
Standard |
USP34 |
|
ITEMS |
SPECIFICATIONS |
RESULTS |
|
|
Description |
Yellow to light-orange crystalline powder |
Yellow crystalline powder |
|
|
Identification :A B |
UV IR |
Complies Complies |
|
|
Solubility |
Insoluble in water,slightly soluble inalcohol and in chloroform |
Complies |
|
|
Loss on drying |
Not more than 0.5% |
0.04% |
|
|
Residue on ignition |
Not more than 0.1% |
0.03% |
|
|
Heavy metals |
Not more than 0.002% |
＜0.002% |
|
|
Limit of isotretinoin |
Not more than 5.0% |
0.56% |
|
|
Particle size |
99% less than 20um |
Complies |
|
|
Organic volatile impurities |
Meet the requirements |
Complies |
|
|
Assay |
98.0～102%(Calculated on the dried basis) |
99.9% |
|
|
Conclusion |
Test results conform with USP34 |
||
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