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Sinoway Industrial Co. Ltd
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Product name
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Rivaroxaban
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CAS No.
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366789-02-8
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Molecular Formula
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C19H18ClN3O5S
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Molecular Weight
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435.8813
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Quality Standard
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98% up, Medicine Grade
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Appearance
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White powder
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TEST
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SPECIFICATION
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RESULTS
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Appearance
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White to off-white powder
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White powder
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Identification
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A: The infrared absorption of rivaroxaban corresponds to reference standards
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Conforms
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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
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Conforms
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ENANTIOMERIC PURITY
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RVX RC01: NMT 0.15%
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None detected
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WATER (KF)
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NMT 0.5%
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0.2%
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SULPHATED ASH
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NMT 0.1%
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0.02%
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ACETIC ACID
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NMT 5000 ppm
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774 ppm
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RELATED SUBSTANCES(HPLC)
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RVX RC02: NMT 0.15%
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None detected
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RVX RC03: NMT 0.15%
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None detected
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RVX RC04: NMT 0.15%
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None detected
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RVX RC05: NMT 0.15%
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0.04 %
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RVX RC06: NMT 0.15%
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< disregard limit (0.03%)
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RVX RC07: NMT 0.15%
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None detected
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RVX RC08: NMT 0.15%
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None detected
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Any other individual impurity: NMT 0.10%
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0.07%
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Total impurities: NMT 0.5%
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0.15%
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RESIDUAL SOLVENTS (GC)
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Ethanol: NMT 5000 ppm
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26 ppm
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Toluene: NMT 890 ppm
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None detected
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Triethylamine: NMT 320 ppm
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None detected
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ASSAY
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NLT 98.0% & NMT 102.0% (on anhydrous basis)
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100.1%
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STORAGE
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Preserved in tight and light resistant container
Temperature: ≤ 30。C
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CONCLUSION
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The product complies with the specification of In-house standard
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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).
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ZHEJIANG SACHEM PHARMACEUTICAL TECHNOLOGY CO., LTD
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Since its establishment, Zhejiang Saikai Pharmaceutical Technology Co., Ltd. has continuously enhanced its resource integration ability around the pharmaceutical industry chain, built an enterprise-oriented and market-oriented business system, actively identified the key links of the upstream and downstream of the industrial chain, and promoted the overall improvement of the supply chain.
The company has always been committed to opening the international market for small and medium-sized production enterprises. Through the efforts of professional international business team, the company has helped steroid hormone apis and intermediates gain a certain market voice in India. Based on the existing achievements, the company insists on expanding the product line, and has established cooperative relations with many manufacturers in Zhejiang, Hunan, Jiangsu and other provinces. In addition to India, the products are exported to Europe, South America and other overseas regions, and a broad sales market has been established.
Since 2023, relying on the head office to carry out API import, registration and agent procurement business. Under the cooperation of the total company registration team, the company successfully completed the introduction and registration of a number of high-quality apis, and established product cooperation with foreign first-line enterprises, and successfully helped the parent company and domestic pharmaceutical customers related review.
In the future, Sikai Pharmaceutical will forge ahead, do not slack, focus on improving the level of business, to create an excellent corporate brand image. We will make full use of our own advantages, continue to integrate domestic and foreign resources, through strategic cooperation to reach a strong alliance between enterprises, to achieve mutual benefit, mutual assistance and win-win. |
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Pharma Sources Insight January 2025
