Sofosbuvir 1190307-88-0 PSI-7977
1. can supply in large quantity, 100-200/lot, 2000-3000kg/month
2. first company who commercialized it to ton lots
3. production in GMP factory
4. quality is steady, after we did several batch of formulations
5. quality is good, higher purity, lower impurity
6. service is good, we insure a fast shipping, both sample and commercial shipment.
7. we need to receive your order in advance if your order is commercialized.
Items |
Requirements |
|
Appearance |
white or almost white powder |
|
Solubility |
Freely soluble in methanol, ethanol, acetonitrile; Slightly soluble in ethyl acetate; sparing soluble in water; practically insoluble in n-heptane |
|
Specific optical rotation |
+37.0 ~+41.0 |
|
Identification |
IR |
The infrared absorption spectrum of the sample corresponds to that of the reference standard |
|
HPLC |
The retention time of the major peak of the sample solution corresponds to that of standard solution, as obtained in assay |
water |
≤0.5% |
|
Clarity of solution |
Solution should be clear |
|
Related substance |
Impurity A ≤0.3% |
|
|
Impurity B ≤0.15% |
|
|
Impurity C ≤0.20% |
|
|
Impurity D ≤0.15% |
|
|
Impurity F ≤0.15% |
|
|
Unspecified impurity ≤0.10% |
|
|
Total impurity ≤1.0% |
|
Residual solvents |
Isopropanol ≤0.50% |
|
|
N-heptane ≤0.50% |
|
|
Ethyl acetate ≤0.50% |
|
|
Dichloromethane ≤0.060% |
|
|
Tetrahydrofuran ≤0.072% |
|
|
N,N-Diisopropylethylamine ≤0.10% |
|
|
Methanol ≤0.30% |
|
Impurity element |
As ≤1.5ppm |
|
|
Cd ≤0.50ppm |
|
|
Hg ≤4.0ppm |
|
|
Pb ≤0.50ppm |
|
|
Co ≤5.0ppm |
|
|
Mo ≤18ppm |
|
|
Se ≤17ppm |
|
|
Vanadium ≤12ppm |
|
Assay |
Contains 98.0~102.0% of C22H29FN3O9P (anhydrous substance ) |
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