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Eplontersen API (CAS 1637600-16-8) is a new-generation liver-targeted antisense oligonucleotide raw material that selectively inhibits transthyretin (TTR) synthesis. It provides an innovative therapy for hereditary ATTR amyloidotic polyneuropathy with high precision and favorable safety. By reducing TTR levels and preventing amyloid fibril deposition, it effectively delays disease progression and improves neurological function, serving as a key pharmaceutical ingredient for ATTR amyloidosis treatment.
Technical Specifications
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Product Name |
Eplontersen API |
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Synonyms |
Eplontersen Powder, Eplontersen Raw Material |
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Characteristics |
A off-white to light yellow solid powder |
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CAS Number |
1637600-16-8 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
GalNAc3-conjugated 20-mer ASO |
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Package |
Technical Package |
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Storage |
Store at -20°C for 3 years or 4°C for 2 years, tightly sealed, dry, protected from light; storage under nitrogen is recommended. Solutions: stable for 6 months at -80°C or 1 month at -20°C; avoid repeated freeze-thaw cycles. |
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Structure |
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Eplontersen Powder is a highly targeted antisense oligonucleotide API focused on hereditary transthyretin amyloidosis, with important value in precision rare disease therapy. It silences pathogenic gene expression to block abnormal protein formation, delivering reliable raw material support for clinical applications.
Product Features
Eplontersen API (CAS 1637600-16-8) features GalNAc₃ conjugation for precise hepatocyte targeting, enhancing delivery efficiency, lowering systemic exposure, and improving safety and tolerability.
As a 20-mer antisense oligonucleotide, Eplontersen Raw Material specifically degrades TTR mRNA to inhibit pathogenic protein synthesis with minimal disruption to normal physiological pathways.
With HPLC-tested purity ≥99.0%, the product meets pharmaceutical-grade API standards. It is a white lyophilized powder with excellent stability at -20°C, suitable for formulation development and large-scale production.
Full-Cycle Quality Control & Consistent Quality
Source Control & Compliant Raw Materials
Eplontersen API is fully traceable from starting materials to intermediates, all complying with pharmacopoeial requirements to ensure batch consistency and reliable quality.
Process Control & Precise Management
The whole production process uses real-time monitoring and strict parameter control to maintain stable manufacturing, reduce impurities, and guarantee product purity and activity.
Finished Product Testing & Strict Standards
Finished products are validated by HPLC, LC-MS and other methods. Purity ≥99.0%, with all indicators meeting ICH and pharmaceutical-grade API specifications.
Continuous Optimization & Stable Assurance
A full-lifecycle quality traceability system is implemented with regular process verification and stability studies to ensure consistent quality in long-term storage and mass supply.
Application Scenarios
With high targeting performance and reliable quality, Eplontersen API is widely used in innovative drug R&D, clinical production and scientific research for rare disease therapies.
It is mainly applied in the development and manufacture of drugs for hereditary transthyretin amyloidosis, supporting clinical formulation development and therapeutic supply.
It serves pharmaceutical companies worldwide for drug registration, clinical trials and commercial production, providing stable upstream support for liver-targeted oligonucleotide medicines.
It also supports advanced research in precision rare disease treatment, supplying high-quality materials for mechanism studies and new therapy development.
Compatible with the global pharmaceutical supply chain, it is available to R&D institutions, manufacturers and CDMOs for R&D, pilot and large-scale production.
Packaging and Transportation
To preserve the quality and activity of Eplontersen API, we apply pharmaceutical-grade standards for packaging, transportation and full-process traceability to ensure safe delivery.
The product is packaged in pharmaceutical-grade sealed containers with light and moisture protection and inert gas blanketing. Multiple specifications are available, and customized Eplontersen API packaging is supported.
Transportation is carried out via low-temperature cold chain with insulated containers and dry ice to avoid high temperatures and repeated freeze-thaw cycles.
All packages are clearly labeled with traceable codes, complying with international logistics regulations and enabling reliable cross-border delivery.
Our Advantages
Core Technology
With rich experience in oligonucleotide APIs, we possess proprietary synthetic processes enabling stable mass production of Eplontersen API with consistent quality.
Quality Control
We implement a full-process quality management system. Each batch is comprehensively tested, with purity and impurity control exceeding industry standards.
Supply & Service
We offer flexible supply from small R&D samples to large industrial orders, with prompt delivery to support drug development and registration.
Technical Support
Our professional technical and regulatory team provides complete documentation and personalized support to facilitate compliant project development.
FAQ
As a professional China Eplontersen API manufacturer, we produce Eplontersen API made in China under strict global quality systems with full traceability. As a key raw material for ATTR amyloidosis therapy, Eplontersen Raw Material supports drug R&D and commercial production in the rare disease field. With stable supply and professional services, we cooperate closely with global partners to promote progress in rare disease treatment.
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