Business Type:Trading Company
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Country: China (Mainland)
Business Type:Trading Company
CAS NO.143491-57-0
A(1-2)Kilogram
ASSAY ITEMS | SPECIFICATION | TEST RESULTS |
Description |
White to almost white crystalline powder |
white crystalline powder |
Solubility |
Freely soluble in Methanol and Water, Practically insoluble in Dichloromethane |
Complies |
Identification | The infrared absorption spectrum of test sample is concordant with the spectrum obtained from Emtricitabine Reference Standard. | Complies |
Specific optical rotation in 2.5mg/ml water solution is -105.0° to -115.0° |
-109.3° |
|
Limit of Emtricitabine Enantiomer |
NMT 0.3% |
Not detected |
Loss on Drying |
NMT 0.5% |
0.16% |
Heavy Metals |
NMT 20ppm |
Complies |
Residue on Ignition |
NMT 0.1% |
Complies |
Related Substance |
Any impurity before the principal peak NMT 0.5% |
Complies |
NMT 2 impurities over 0.1% before the principal peak | Complies | |
Any impurity after the principal peak NMT 0.7% |
Complies |
|
NMT 2 impurities over 0.1% after the principal peak |
Complies |
|
Total impurities NMT 1.0% (Disregarding impurity less than 0.05%) | 0.14% | |
Residual Solvents |
Ethanol NMT 0.50% |
0.04% |
Dichloromethane NMT 0.06% |
Not detected |
|
DMF NMT 0.088% |
Not detected |
|
Triethylamine NMT 0.032% |
Not detected |
|
Toluene NMT 0.089% |
Not detected |
|
Assay(dry basis) |
99.0% - 101.0% |
100.8% |
Conclusion |
Qualified |