Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing admin@sinochem-nanjing.com 3389378665@qq.com
Follow us:

Eritoran

    • Product Name Eritoran
    • Alias E5564
    • Einecs NA
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry admin@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    787319

    Name Eritoran
    Chemical Class Lipid A analogue
    Molecular Formula C76H148N2O16P
    Cas Number 227084-58-2
    Mechanism Of Action Toll-like receptor 4 (TLR4) antagonist
    Indication Sepsis (investigational)
    Route Of Administration Intravenous
    Developer Eisai Co., Ltd.
    Clinical Trial Phase Phase III (failed primary endpoint)
    Molecular Weight 1360.98 g/mol
    Synonyms E5564
    Storage Conditions 2-8°C (refrigerated)
    Appearance White to off-white powder
    Solubility Soluble in water
    Target TLR4–MD-2 complex

    As an accredited Eritoran factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing Eritoran packaging: 50 mg vial, clear glass with a flip-off cap, labeled with batch number, storage instructions, and manufacturer details.
    Shipping Eritoran is shipped as a refrigerated, temperature-sensitive chemical. It is packaged in sealed containers to prevent contamination and degradation. Shipment is conducted according to international regulations for pharmaceutical and research materials, with cold chain logistics (typically 2–8°C), and accompanied by safety and handling documentation to ensure product integrity during transit.
    Storage Eritoran should be stored at -20°C, protected from light, and kept in a tightly sealed container to maintain its stability and prevent degradation. It should be handled in a dry environment, away from moisture and incompatible substances. When ready to use, erythoran solutions should be prepared freshly and stored at 4°C for short-term use, avoiding repeated freeze-thaw cycles.
    Application of Eritoran

    Applications of Eritoran in Industrial Manufacturing

    As a high-purity synthetic lipid A analog, Eritoran serves key functions in several pharmaceutical and biomedical manufacturing sectors. Our manufacturing expertise ensures reliable supply for leading industrial users specializing in immunomodulation and anti-infective product pipelines. The following sections outline established downstream application scenarios supported by industry compliance standards and solid process integration.

    1. Injectable Pharmaceutical Formulations for Sepsis Management

    Pharmaceutical manufacturers utilize Eritoran in the formulation of sterile intravenous medications indicated for the management of severe sepsis and septic shock. Its endotoxin antagonist properties are integrated into small molecule pipeline drugs following stringent containment and traceability practices. The production process involves aseptic compounding, sterilization filtration, and filling under GMP-controlled conditions to ensure clinical safety and batch uniformity for subsequent use in parenteral therapies.

    Industry compliance standards

    • ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients
    • EU GMP Annex 1 Sterile Medicinal Products
    • Ph. Eur. and USP Monographs for Injectable Dosage Forms
    • FDA 21 CFR Parts 210/211 – cGMP Regulations

    Typical usage ratio

    • Formulation use levels between 0.5 and 4 mg per dose, with concentration in drug products ranging from 0.05 to 0.4 mg/mL; final concentration adjusted based on target patient weight and clinical phase requirements.

    Downstream process integration

    • Eritoran is dissolved in sterile water for injection during early-stage buffer preparation, followed by sterile filtration and aseptic filling into vials or infusion bags under Class A cleanroom conditions.

    Final product types

    • Ready-to-use injectable solutions for clinical administration
    • Pre-filled oncology and critical care vials
    • Commercially licensed parenteral drugs for sepsis intervention

    2. Vaccine Adjuvant Systems for Human Immunotherapy

    Biomedical R&D and commercial vaccine production settings use Eritoran as a Toll-Like Receptor 4 (TLR4) antagonist component in injectable adjuvant systems. It fine-tunes innate immune responses, contributing to the development of advanced vaccine platforms for infectious diseases and cancer immunotherapy. Large-scale adjuvant blending and in-process controls ensure consistency and stability during vaccine bulk preparation and terminal filling stages.

    Industry compliance standards

    • WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants
    • Ph. Eur. 5.2.3 Adjuvants in Vaccines for Human Use
    • FDA Guidance on Development and Licensure of Vaccines
    • ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological Products

    Typical usage ratio

    • Adjuvant system formulations commonly contain Eritoran at 1 to 10 μg per human dose; the content is set according to preclinical immunogenicity data and batch release specifications.

    Downstream process integration

    • The compound is blended into vaccine antigen suspensions during the adjuvant combination step prior to final sterilizing filtration and bulk fill–finish operations.

    Final product types

    • Multidose vaccine vials for clinical or research use
    • Investigational cancer immunotherapeutic injectables
    • Licensed vaccines incorporating synthetic TLR4 antagonists

    3. Cell Culture Media Supplementation for Endotoxin Control

    Advanced biotechnology processing lines, particularly those manufacturing recombinant therapeutic proteins and monoclonal antibodies, utilize Eritoran as a cell culture media supplement to mitigate endotoxin-induced cellular stress. The compound is added during preparation of basal or feed media, where its presence supports reduced cytokine activation, enabling higher yield and product consistency in mammalian cell bioreactors. Stringent raw material traceability and bioburden control are maintained throughout the media blending and storage steps.

    Industry compliance standards

    • USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
    • ISO 13485:2016 Quality Management for Medical Devices
    • Ph. Eur. 5.2.8 Raw Materials of Biological Origin
    • ICH Q9 Quality Risk Management

    Typical usage ratio

    • Eritoran levels range from 10 to 200 ng/mL in cell culture media, with the exact addition scaled to anticipated endotoxin load and specific cell line susceptibility determined by pre-manufacturing risk assessment.

    Downstream process integration

    • Manufacturers introduce Eritoran during media formulation or as an in-line supplement prior to large-scale cell inoculation, following filter sterilization and validated mixing procedures.

    Final product types

    • Recombinant therapeutic protein APIs
    • Monoclonal antibody drug substance batches
    • Cell-based diagnostic reagents

    4. Endotoxin Detection System Reference Standards

    Diagnostic reagent manufacturers and pharmaceutical QC labs incorporate Eritoran as a validated reference standard or assay inhibitor within Limulus Amebocyte Lysate (LAL) and recombinant Factor C (rFC) endotoxin detection kit development. Its function as a competitor ligand allows verification of assay specificity and controls for false positives, supporting compliant lot release and in-process monitoring of critical sterile drugs and medical devices.

    Industry compliance standards

    • USP <85> Bacterial Endotoxins Test
    • Ph. Eur. 2.6.14 Bacterial Endotoxins
    • ISO 11979-8:2017 Biocompatibility of Medical Devices
    • FDA Guidance for Industry—Pyrogen and Endotoxins Testing

    Typical usage ratio

    • Assay kit inhibitors and reference controls include Eritoran at concentrations from 0.05–2 μg/mL; levels calibrated through method validation per test type and matrix complexity.

    Downstream process integration

    • Reagent production teams blend Eritoran into lyophilized or liquid control vials during kit assembly, following mixing, aliquoting, and sealing operations under cleanroom conditions.

    Final product types

    • LAL endotoxin testing kits (quantitative/qualitative)
    • rFC reagent systems for drug and device release testing
    • Laboratory reference standards for regulatory submissions
    Free Quote

    Competitive Eritoran prices that fit your budget—flexible terms and customized quotes for every order.

    For samples, pricing, or more information, please call us at +8615371019725 or mail to admin@sinochem-nanjing.com.

    We will respond to you as soon as possible.

    Tel: +8615371019725

    Email: admin@sinochem-nanjing.com

    Get Free Quote of Sinochem Nanjing Corporation

    Flexible payment, competitive price, premium service - Inquire now!

    Certification & Compliance
    More Introduction

    Eritoran: Taking Endotoxin Inhibition to a New Level

    Direct From the Manufacturer: Bringing Science to Life

    We have spent years deep in the trenches of chemical synthesis, taking concepts from raw journals and transforming them into batches that offer reliability and performance. Eritoran stands as a testament to what careful design, solid control of process conditions, and first-hand production experience can deliver. Our entire operation is dedicated to producing this innovative endotoxin antagonist with the consistency and scale expected by hospitals, research institutes, and pharmaceutical companies worldwide.

    What Is Eritoran?

    Eritoran (E5564) blocks the toxic effects of bacterial lipopolysaccharide by directly binding to the MD-2/TLR4 complex. In plain terms, Eritoran acts as a decoy for the molecular patterns that trigger systemic inflammation, particularly sepsis. Manufactured to strict specifications, our batches must achieve tight purity and structural requirements, as deviations in this space directly affect both safety and performance outcomes.

    Our Approach to Synthesis

    Years of development have taught us that shortcuts in the lab compromise the final product. For Eritoran, slight variances in side chain assembly or purification steps tip the balance away from safety. We employ high-throughput chromatography and finely tuned solvent systems, and every run receives detailed spectroscopic analysis. This lets us offer Eritoran lots where the identity, purity, and absence of contaminants hold up even under international scrutiny.

    Quality That Impacts Real-World Outcomes

    Endotoxin antagonists like Eritoran never get used in trivial settings. End-organ damage and high-risk infections demand a product that doesn’t introduce new problems. Through continuous review of impurity profiles and robust cleaning protocols, we avoid cross-contamination and ensure that each milligram meets therapeutic expectations. The manufacturing line posts data that passes regulatory audits and serves as fit-for-purpose reference material in clinical settings.

    Specifications: More Than Numbers on a Sheet

    A physical sample tells more than paperwork. Consistent molecular weight, color, and solubility are all basic markers, yet small details—a genuine lack of pyrogenicity, for example—matter most. Our Eritoran typically appears as a lyophilized, off-white powder, provided in vials that support accurate dispensing. Polymorphic consistency, verified by XRPD and FTIR, secures batch-to-batch reliability. Residual solvent analysis repeatedly benchmarks well below regulatory thresholds, since our purification steps lean on in-house fractional distillation and exhaustive vacuum drying.

    Supporting Clinicians and Researchers

    Daily, we field questions from physicians and scientists about reproducibility, shelf stability, and adaptability for research protocols. Our years on the production line answering these questions have improved how we store, ship, and label Eritoran. Real experience tells us that storage at -20°C, in the original sealed vial, preserves potency for extended timelines without the need for repeated re-certification. Our packaging withstands temperature cycling, a major concern during international logistics.

    How Eritoran Differs From Other Products

    A manufacturer’s view reveals what rarely shows up in brand comparisons. The production of Eritoran involves synthesis and purification challenges that generic LPS blockers simply can’t address. Poorly characterized alternatives sometimes reach the market with residual by-products or incomplete saponification, undermining intended pharmacological effects. By contrast, we control every aspect from raw input to final vial, ensuring chemical identity through high-resolution analytical methods. The result: reproducible LPS antagonistic activity at low nanomolar concentrations, and minimized off-target effects.

    Standard TLR4 antagonists may act through less specific mechanisms or with incomplete inhibition. Eritoran’s strong selectivity for the MD-2/TLR4 site makes off-target immune suppression less likely. Some analogs or unapproved imports come with minor differences in fatty acid composition that upend function, or with careless purification that leaves behind irritants. Here, picking the right synthetic route and following it batch after batch creates confidence in each milligram delivered.

    Facing Real Manufacturing Challenges

    Large-scale synthesis of Eritoran forced us to upgrade safety and process monitoring. Accidents can result from miscalculating the scale-up of reactive intermediates, and so we have invested in everything from advanced exhaust filtration to automated thermal sensors. Real-time in-process analytics catch off-specifications before impurities have a chance to accumulate. We have walked through countless root-cause analyses, where overlooked factors would have otherwise compromised quality.

    Getting the fatty acid tail right calls for special attention. The purity of starting phospholipid matters for downstream performance, and side reactions during activation leave troublesome byproducts. Our process uses high-quality input, paying the extra cost up front to avoid contamination. Each large batch undergoes both small-scale pilot trials and stress testing before release, letting us address stability, solubility, and dispersibility long before the product ends up beyond our walls.

    Supporting Reliable Research and Global Health Needs

    Clinicians and industry partners count on a supply chain where tomorrow’s dose is the same as today’s. Supply interruptions can cost lives, especially in critical care. That insight comes from direct conversations with clinicians frustrated by shortages elsewhere. Our production calendar works backward from customer demand, never the pursuit of surplus volume at the cost of traceability. We coordinate with specialty transport partners who appreciate the consequence of a late or ruined shipment.

    Academic partners return to us because our certifications and real performance match. The same analytical data sheet we deliver with each order comes from equipment monitored daily, and from analysts who sign off on every batch with their own names and reputations. This level of accountability survives audits and supports long-term publication of reproducible research.

    Tracing the Raw Materials

    Traceability starts with reliable sourcing. We have rejected suppliers unable to meet documentation standards—no paperwork, no shipment. Our suppliers undergo annual audits, and we requalify key reagents with full documentation. Critical solvents and acids come from established vendors who understand the downstream impact in pharmaceutical synthesis. Every kilogram entering our plant gets a barcode, undergoes identification by NMR or GCMS, and ends up tracked through each stage of Eritoran production.

    Minimizing Environmental Impact

    Chemical manufacturing carries a burden of responsibility. We spent years developing waste treatment steps that despise shortcuts. Our facilities run closed-process solvents wherever feasible, and intensive operator training reduces accidental releases. All effluents undergo multi-stage filtration and monitored pH adjustment. Spent solvent is collected, distilled, and reused when purity allows. Solid by-products are tested for hazardous content before leaving our premises via certified disposal providers.

    The water system supporting Eritoran manufacture is monitored for trace contaminants daily, and we submit quarterly samples for third-party analysis. This is the only way our customers and regulators can feel confident that the product they inject reflects uncompromised commitment from molecule to vial.

    Packaging and Labeling Integrity

    Our technical team holds a strong opinion about clear, informative labeling. Labels show batch number, fill weight, and storage instruction, encoded with tamper-evidence that can’t be easily duplicated. Each shipping container includes a detailed manifest and a temperature monitor that records transit conditions from our docks to your facility. These extra steps stem from years of hearing about ruined product or ambiguous chain-of-custody in the field.

    Meeting Regulatory Standards Head On

    Managing Eritoran production for pharmaceutical and research customers draws us into direct contact with regulatory inspectors from multiple regions. Our documentation process responds not just to local rules, but to the expectations of international partners and health authorities. We keep training logs, test method validations, and deviation investigations easily accessible for auditors. The learning curve is steep, but we have built a habit of transparency that lets us resolve questions before they stall production or shipment.

    Real-World Applications and Outcomes

    In clinical research, Eritoran helps interrogate the molecular bases of sepsis and other acute inflammatory disorders. Hospitals reach for Eritoran during times of critical care, where every hour of delayed treatment counts. In our industrial partnerships, Eritoran serves as a gold-standard comparator for new TLR4 antagonists, setting a high bar for biological and chemical stability. These applications go beyond bench-top curiosity—they play a pivotal role in modern medicine, reshaping the approach to infections that resist traditional therapies.

    Direct Customer Feedback Shapes Our Approach

    Customer feedback isn’t a formality for us. Every complaint, suggestion, or shared experience drives us to double-check our own systems and protocols. We have incorporated suggested design changes in packaging, response times, and data sharing based on direct reports from clinical partners. It might take longer to roll out a new batch or improve a process, but that time pays off when product reliability is on the line.

    Solving Shortages and Key Supply Chain Gaps

    The global supply chain has become unpredictable, especially for specialty chemicals like Eritoran. We have faced shortages of critical precursors before, and our approach included carrying ample safety stocks, qualifying second sources, and planning production campaigns well in advance. Real shortages demand direct action, not finger-pointing or delay. Our team works overtime to troubleshoot, reorganize raw material priorities, and reallocate plant time if key customers face a shortage. Never letting stockouts dictate patient care stands as a core value since day one.

    Focus on Continuous Improvement and Training

    Progress in chemical manufacturing never stops. Our team undergoes regular training on the newest analytical methods, data integrity expectations, and safe handling protocols. Every member, from junior technician to plant supervisor, must know not only the steps in Eritoran production but also the ‘why’ behind each control. We sponsor technical workshops to bridge production and laboratory staff, avoiding misunderstandings or overlooked trends. Lessons learned from near-misses and audit findings feed into our next production cycle, closing the gap between good practice and world-class performance.

    Working Toward Greater Access Worldwide

    Not every hospital or research center operates with deep pockets or flawless supply lines. We are developing new strategies to package and distribute Eritoran to regions with unreliable refrigeration or tough customs environments. Multipack options, cold-chain independent ampoules, and regulatory pre-clearance form a part of our upcoming solutions. By collaborating with humanitarian organizations and public health authorities, we hope to broaden access to Eritoran for those on the front lines of infection management—regardless of geography or income.

    Challenges and Future Directions

    Even after years manufacturing Eritoran, we still see hurdles on the horizon. New regulatory standards call for even tighter impurity controls and enhanced traceability. Emerging applications in immunotherapy research test our limits for batch size and documentation. As combinations with biologics and cell therapies take off, our next challenge will be to scale up without compromising the tight controls that define our product. Adaptation means investing in both new equipment and fresh expertise—a path we embrace as essential for ongoing leadership in the field.

    What Sets Manufacturer Experience Apart

    As we look ahead, it’s the blend of scientific rigor and practical production experience that builds trust in what we do. Eritoran is more than a synthetic challenge; it is an ongoing responsibility. Every decision—from the quality of glass in a vial to the choice of anionic reagents in our reactors—shapes the safety and reliability experienced by thousands around the world. No glossy brochure or neutral descriptor makes up for this lived knowledge, the results of years on the production floor, hands-on troubleshooting, and transparent data sharing with our customers.

    Your Next Steps

    We welcome conversations with those who demand substance over speculation, and value the insight of manufacturers who spend their days with the science and sweat behind each batch. Eritoran reflects every hour invested in making it what it is—a stable, well-characterized, and trusted TLR4 antagonist for both clinical and research use. From sourcing to synthesis, packaging to partnership, we invite you to measure us by the strength of our commitment and the rigor of our results.