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喜樹堿 黃體酮 噻菌靈/噻苯咪唑 硫酸新霉素 紅霉素
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
Solubility
Practically insoluble in water,soluble in methylene chloride,slightly soluble in alcohol
Related Substances
Tretinoin ≤1.0%
0.35%
Organic volatile impurity
Loss on drying
≤0.5%
0.1%
Residue on ignition
≤0.1%
0.03%
Residual Solvents
Methanol≤3000ppm
Ethyl Acetate≤5000ppm
Hexane≤290ppm
Heavy metals
<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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