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Product Name |
Ritonavir |
CAS No |
155213-67-5 |
Molecular Formula |
|
Molecular Weight |
C37H48N6O5S2 |
Manufacturing date |
20191008 |
Batch No |
20191008 |
Index Name |
Specification |
Result |
Appearance |
White to off- white powder |
Conforms |
Identification by IR |
The infrared absorption spectrum of sample conforms with reference standard |
Conforms |
Identification by HPLC |
The retention time of the major peak of the Sample solution is within 2% of the retention time of the major peak of the standard solution,as obtained in the Assay |
Conforms |
Water content(by KF) |
Not more than 0.50% |
0.09% |
Residue on ignition |
Not more than 0.20% |
0.05% |
Heavy Metals |
Not more than 0.002% |
Conforms |
Related Substance
|
Impurity E(RRT=0.36):Not more than 0.30% |
ND |
Impurity O(RRT=1.11):Not more than 0.30% |
ND |
|
Impurity T(RRT=2.87):Not more than 0.20% |
ND |
|
Any other individual impurity : Not more than 0.10% |
0.09%
|
|
Total impurities: Not more than 1.0% |
0.24% |
|
Residue Solvents
|
MTBE:Not more than 5000ppm |
ND |
Methanol:Not more than 5000ppm |
ND |
|
Toluene:Not more than 890ppm |
ND |
|
Tetrahy drofuran:Not more than 720ppm |
ND |
|
Ethyl acetate:Not more than 5000ppm |
961ppm |
|
Heptanc:Not more than 5000ppm |
252ppm |
|
2-propanol:Not more than 5000ppm |
ND |
|
Ethanol:Not more than 5000ppm |
ND |
|
Assay by HPLC(On dry basis) |
98.0%~102.0% |
99.2% |
Conclusion |
Conforms to the standard of USP 38 |
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It also has hardware facilities and support teams that match the strength of R & D and production: With LCMS, HPLC and other perfect detection means, professional testing team and perfect quality control system; With a pilot base, a stable GMP standard production capacity, and a new GMP workshop is building; With regular financial, legal ERP system and professional sales and logistics team.
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