USP/EP WC+DMF D90 ＜10um Rivaroxaban Form I 366789-02-8

Name: USP/EP WC+DMF D90 ＜10um Rivaroxaban Form I 366789-02-8
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Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:USP/EP WC+DMF D90 ＜10um Rivaroxaban Form I 366789-02-8
CAS No.:366789-02-8
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

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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).

1. Diosmin/Hesperidin 90：10      refer to EP10 GMP+DMF
2. Spironolactone        CEP/EP10 GMP+DMF/CEP
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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USP/EP WC+DMF D90 ＜10um Rivaroxaban Form I 366789-02-8

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

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.

Our advantages of Rivaroxaban (CAS:366789-02-8) :
1. Quality: Form I,assay 98% up ,conform to USP/EP standard ,

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