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As a new-generation siRNA cardiovascular API, Inclisiran Sodium API (CAS 1639324-62-1) delivers long-acting lipid regulation for atherosclerosis treatment and lipid management. Optimized from CAS 1639324-58-5, Inclisiran Sodium Powder shows better stability and druggability with specific PCSK9 targeting, long duration and high safety, ideal for hypercholesterolemia and high-risk cardiovascular patients. As a trusted China Inclisiran Sodium API manufacturer, we ensure stable supply.
Technical Specifications
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Product Name |
Inclisiran Sodium API |
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Synonyms |
Inclisiran Sodium Powder, Inclisiran Sodium Raw Material |
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Characteristics |
A white to off-white crystalline powder |
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CAS Number |
1639324-62-1 |
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Assay |
≥98.0% (HPLC) |
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Formula |
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Package |
Technical Package |
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Storage |
Shipping Temperature: 2-8 degrees Storage: -20 Degrees Celsius |
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Structure |
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Inclisiran Sodium API (CAS 1639324-62-1) is manufactured under stringent process and quality control, with all specifications meeting international pharmaceutical standards.Compared with CAS 1639324-58-5, it shows better water solubility and stability, featuring high purity, controllable impurities and excellent batch-to-batch consistency.
As a new-generation siRNA-based cardiovascular targeted raw material, it supports drug R&D, clinical validation and large-scale production, providing key support for innovative therapies targeting dyslipidemia and atherosclerosis.
Product Features
Produced through a proprietary salt-forming process, High Purity Inclisiran Sodium API features stable and uniform structure with strictly controlled key quality indicators, including high purity, low impurities, and consistent content, meeting high-quality standards for cardiovascular and cerebrovascular drug raw materials.
As a new-generation siRNA lipid-lowering API, it boasts a novel and distinctive mechanism of action, efficiently targeting and regulating PCSK9 expression with long-lasting and stable efficacy, offering significant clinical advantages over traditional lipid-lowering raw materials. Our Inclisiran Sodium API made in China is widely recognized for its stable performance.
The whole production process follows standardized quality control procedures with complete data traceability from raw material feeding to finished product release, ensuring excellent batch consistency and reproducibility to steadily support pharmaceutical R&D and commercial production.
With strong targeting, clear in vivo action, and favorable safety, the product is suitable for the development of drugs against hypercholesterolemia and atherosclerosis, serving as core raw material support for innovative preparations in the cardio-renal metabolic field.
Full-Cycle Quality Control & Consistent Quality
From raw material procurement and synthesis to refining and purification, Inclisiran Sodium API is manufactured under standardized quality control, with multiple inspection points set for key processes to ensure a controllable and traceable production process, guaranteeing stable and reliable product quality from the source.
Relying on a comprehensive analytical and testing system, we strictly control core indicators such as purity, impurity profile, and physicochemical properties. All indexes meet international regulatory requirements, with excellent batch-to-batch consistency, effectively reducing risks in pharmaceutical R&D and production. We are among the leading China Inclisiran Sodium API suppliers with rigorous QC systems.
A long-term stability monitoring system is established to continuously track quality changes under various storage conditions. Production and quality control schemes are continuously optimized through data accumulation, providing customers with long-term stable and reliable raw material products.
Application Scenarios
As a new-generation siRNA-based cardio-cerebrovascular API, Inclisiran Sodium API (CAS 1639324-62-1) features a unique long-acting mechanism and excellent druggability. It is widely used in lipid regulation and atherosclerosis-related fields, providing critical raw material support for multiple unmet clinical needs.
The product is mainly used in the R&D and production of drugs for hypercholesterolemia, serving as a core API for interventions in patients with primary hypercholesterolemia and mixed dyslipidemia, offering a stable and reliable raw material choice for long-term clinical lipid management. We provide Inclisiran Sodium API in stock for urgent R&D needs.
In the prevention and treatment of atherosclerotic cardiovascular diseases, the raw material supports the development of related innovative drugs to reduce cardiovascular event risks, meeting clinical demand for long-acting, safe, and convenient lipid-lowering pharmaceuticals.
For pharmaceutical R&D scenarios, the product supports preclinical research, clinical trials, and large-scale post-marketing production. With stable quality and compliant indicators, it adapts to the full process of global drug registration and commercial supply.
In the development of combination therapies for cardio-renal metabolism, the API can be formulated with drugs of other mechanisms, expanding treatment options for patients with dyslipidemia and complications, and supporting personalized medicine and new compound preparations.
Packaging and Transportation
Packaging and transportation of Inclisiran Sodium Powder strictly comply with API GMP standards, balancing product protection, storage safety, and logistics efficiency. The entire chain from packaging design to transportation control is standardized to ensure purity and stability throughout the process.
Customized Packaging Solutions
We offer multi-specification Customized Inclisiran Sodium API packaging, including aluminum foil bags and sealed drums, supporting small-batch trial packages and large-scale commercial packaging. The inner layer uses moisture-proof and oxygen-barrier materials to isolate moisture and air.
Professional Protective Packaging Design
The outer packaging is equipped with pressure-resistant buffers and anti-leakage structures, suitable for long-distance transportation and multiple transfers. Clear product information, batch numbers, and storage instructions are labeled to reduce logistics errors.
Precision-Controlled Cold-Chain Transportation
In response to low-temperature storage requirements, professional cold-chain transportation is provided with a constant -20°C environment and real-time temperature recorders to ensure product activity and quality during delivery.
Full-Chain Logistics Support System
A dedicated logistics coordination mechanism is established with optimized routes and shortened transit times. Real-time tracking and complete quality and shipping documents ensure full traceability from warehouse to customer.
Our Advantages
We possess mature and stable synthetic processes for Inclisiran Sodium API, enabling large-scale and consistent production to ensure continuous supply, meeting full-cycle raw material demands from R&D trials to commercial manufacturing. We are a professional China Inclisiran Sodium API factory with large production capacity.
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A full-process quality control system is implemented, with strict testing standards from starting materials to finished products. The product features high purity, excellent impurity control, and strong batch consistency, complying with global pharmacopoeial and registration requirements.
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Our professional R&D and technical support team provides one-stop services from parameter confirmation and process optimization to registration document support, efficiently assisting customers in pharmaceutical development and registration.
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Standard pharmaceutical-grade packaging and professional cold-chain transportation are adopted, with strict control over temperature, humidity, and cleanliness to maximize quality stability during storage and transportation, reducing customer application risks.
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With years of deep cultivation in cardio-renal metabolic APIs, we have profound insights into product properties and industry regulations, combining cost advantages and supply flexibility to be a long-term reliable partner for global pharmaceutical enterprises.
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FAQ
We adhere to international pharma quality standards and focus on producing high-purity Inclisiran Sodium API (CAS 1639324-62-1) with full-process control.
We support global lipid and cardiovascular drug R&D with stable supply from R&D to mass production. We cooperate with worldwide partners to build a win-win industrial ecosystem.
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