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Email ：PharmaSources@imsinoexpo.com
Whatsapp ：+86-13621645194
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 container
Temperature: ≤ 30。C
CONCLUSION
The product complies with the specification of In-house standard
Usage
Function of Rivaroxaban
Rivaroxaban is an oral, bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require cofactors (such as antithrombin III) to exert its activity. Factor X is activated by endogenous and exogenous pathways as factor Xa (FXa), which plays an important role in the coagulation cascade.
1. Rivaroxaban is for adult patients with elective hip or knee replacement surgery to prevent venous thrombosis (VTE).
2. Rivaroxaban is used to treat adult venous thrombosis (DVT) and reduce the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT.
3. Rivaroxaban is for adult patients with non-valvular atrial fibrillation with one or more risk factors (for example: congestive heart failure, hypertension, age ≥75 years, history of diabetes, stroke or transient ischemic attack), to Reduce the risk of stroke and systemic embolism.
In the condition of well-controlled treatment with warfarin, there are limited data on the relative effectiveness of rivaroxaban in reducing the risk of stroke and systemic embolism compared with warfarin.
Our advantages of Rivaroxaban (CAS:366789-02-8) :
1. Quality: Form I,assay 98% up ,conform to USP/EP standard ,
2. Normal PSD D90＜100um & Micron PSD D90 ＜10um.
3. Documents: local GMP,WC and DMF. CEP is under applying. The price with documents is higher than without.
4. Large capacity & stock : 120~180kg per month with 800kg in stock for prompt shipment
5. Better payment terms : We can make use of Export Credit Insurance after confirming yr credit report accepted by Sinosure, accept Alibaba Trade Assurance
6. Various shipping ways for your choice : by air./ by sea / by courier (DHL/FedEx).
Twenty years of qualification
Audited Supplier
Pharma Sources Insight JANUARY 2024
