HANGZHOU CLAKE BIOTECH CO.,LTD
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CAS NO.366789-02-8
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
Micro powder / Crude powder can be made to order
EP/USP both ok
|
ITEMS |
SPECIFICATION |
RESULTS |
|
Appearance |
White or almost 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% |
0.1% |
|
Sulphated ash |
NMT 0.1% |
0.05% |
|
Acetic Acid |
NMT 5000ppm |
783ppm |
|
Related substances (HPLC) |
RVX RC02: NMT0.15% |
None detected |
|
RVX RC03: NMT0.15% |
None detected |
|
|
RVX RC04: NMT0.15% |
None detected |
|
|
RVX RC05: NMT0.15% |
0.06% |
|
|
RVX RC06: NMT0.15% |
0.03% |
|
|
RVX RC07: NMT0.15% |
0.03% |
|
|
RVX RC08: NMT0.15% |
None detected |
|
|
Any other individual impurity : NMT 0.10% |
None detected |
|
|
Total impurities: NMT 0.5% |
0.12% |
|
|
Residual Solvents (GC) |
Ethanol : NMT 5000ppm |
None detected |
|
Toluene: NMT 890ppm |
None detected |
|
|
Triethylamine : NMT 320ppm |
None detected |
|
|
Assay |
NLT 98.0% & NMT102.0% (on anhydrous basis) |
100.8% |
|
Storage |
Preserved in tight and light resistant container. Temperature : ≤30℃ |
|
|
Conclusion: The test results are conformed to the in-house specification |
||