Grade: Pharmaceutical Grade
Factory Location: Xiamen, Fujian
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
Product Information |
Product name |
Rivaroxaban |
CAS No. |
366789-02-8 |
Molecular Formula |
C19H18ClN3O5S |
Molecular Weight |
435.8813 |
Quality Standard |
98% up, Medicine Grade |
Appearance |
White powder |
COA of Rivaroxaban |
TEST |
SPECIFICATION |
RESULTS |
Appearance |
White to off-white powder |
White powder |
Identification |
A: The infrared absorption of rivaroxaban corresponds to reference standards |
Conforms |
|
B: The retention time of the main peak of the sample solution corresponds to that of the system suitability solution, as obtained in the enantiomeric purity |
Conforms |
ENANTIOMERIC PURITY |
RVX RC01: NMT 0.15% |
None detected |
WATER (KF) |
NMT 0.5% |
0.2% |
SULPHATED ASH |
NMT 0.1% |
0.02% |
ACETIC ACID |
NMT 5000 ppm |
774 ppm |
RELATED SUBSTANCES(HPLC) |
RVX RC02: NMT 0.15% |
None detected |
RVX RC03: NMT 0.15% |
None detected |
|
RVX RC04: NMT 0.15% |
None detected |
|
RVX RC05: NMT 0.15% |
0.04 % |
|
RVX RC06: NMT 0.15% |
< disregard limit (0.03%) |
|
RVX RC07: NMT 0.15% |
None detected |
|
RVX RC08: NMT 0.15% |
None detected |
|
Any other individual impurity: NMT 0.10% |
0.07% |
|
Total impurities: NMT 0.5% |
0.15% |
|
RESIDUAL SOLVENTS (GC) |
Ethanol: NMT 5000 ppm |
26 ppm |
Toluene: NMT 890 ppm |
None detected |
|
Triethylamine: NMT 320 ppm |
None detected |
|
ASSAY |
NLT 98.0% & NMT 102.0% (on anhydrous basis) |
100.1% |
STORAGE |
Preserved in tight and light resistant containerTemperature: ≤ 30。C |
|
CONCLUSION |
The product complies with the specification of In-house standard |
Usage |