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Rivaroxaban Form I 366789-02-8

Rivaroxaban Form I 366789-02-8

USP/EP WC+DMF D90 <10um
  • Product Details

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: 30C

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).


Related products:

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3. Gliclazide      EP10/BP2017                                              GMP+DMF/CEP
4. Telmisartan      USP/EP/BP                                               GMP+DMF/CEP
5. Hydrocortisone Base/Acetate      EP/USP                           GMP+DMF/CEP
6. Esomeprazole Magnesium Dihydrate   EP10/ CEP               GMP+DMF/CEP
7. Prednisolone  EP/USP                                                      GMP+DMF/CEP
8. Ropivacaine HCL USP                                                      GMP+DMF
9. Olmesartan Medoxomil CEP/EP                                         GMP+DMF/CEP
10. Azithromycin             EP/USP                                          GMP+DMF/CEP
11. Pemetrexed Disodium                98% up                         WC+DMF/CEP
12. Pregabalin   EP9                                                              WC+DMF/CEP
13. Tenofovir Alafenamide fumarate  99% by HPLC                 DMF 
14. Rivaroxaban     99% by HPLC                                          WC+DMF
15. Rosuvastatin Calcium     EP/USP                                      WC+DMF
16. Irbesartan DC                                                                   60% DC



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