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Edrophonium Chloride

    • Product Name Edrophonium Chloride
    • Alias Tensilon
    • Einecs 200-189-6
    • 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

    384084

    Generic Name Edrophonium Chloride
    Chemical Formula C10H17ClN2O
    Molecular Weight 216.71 g/mol
    Appearance White crystalline powder
    Solubility Freely soluble in water
    Mechanism Of Action Acetylcholinesterase inhibitor
    Route Of Administration Intravenous, Intramuscular
    Indications Diagnosis of myasthenia gravis
    Half Life Approximately 60–75 minutes
    Storage Conditions Store at 20°C to 25°C (68°F to 77°F)
    Prescription Status Prescription only
    Cas Number 314-60-1

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

    Packing & Storage
    Packing A clear glass vial containing 10 mL Edrophonium Chloride injection, labeled with concentration, manufacturer, lot number, and expiration date.
    Shipping Edrophonium Chloride is shipped as a hazardous material under tightly controlled conditions. It should be packed in secure, clearly labeled containers compliant with local and international regulations. Transport must ensure protection from moisture, heat, and physical damage. All relevant safety documentation, including Material Safety Data Sheets (MSDS), must accompany each shipment.
    Storage Edrophonium Chloride should be stored in a tightly closed container at controlled room temperature, ideally between 20°C and 25°C (68°F–77°F). Protect it from moisture, heat, and light. Store in a dry, well-ventilated area away from incompatible substances, such as strong oxidizers. Ensure that it is kept out of reach of unauthorized personnel and properly labeled at all times.
    Application of Edrophonium Chloride

    Applications of Edrophonium Chloride in Industrial Manufacturing

    As a direct producer of Edrophonium Chloride, we supply this active pharmaceutical ingredient for specialized industrial applications across regulated sectors. Below, we present targeted downstream scenarios with process details and key compliance references, reflecting the actual commercial landscape.

    1. Injectable Diagnostic Agents for Clinical Neuromuscular Testing

    Edrophonium Chloride is a reference active compound for formulating injectable test agents used in the diagnostic assessment of neuromuscular disorders, particularly in myasthenia gravis evaluation. Manufacturers use it for sterile solution preparations due to its rapid cholinesterase inhibition, which aids in clinical testing at neurology clinics and hospitals. In these applications, the raw material undergoes solution compounding, sterile filtration, filling, and terminal sterilization steps, following validated pharmaceutical batch protocols. Downstream companies formulate single- and multi-dose vials for intravenous or intramuscular administration, ensuring precise dose accuracy and rapid patient response monitoring.

    Industry compliance standards

    • USP Monograph: Edrophonium Chloride Injection
    • WHO GMP guidelines for sterile APIs
    • 21 CFR Part 210/211 (US cGMPs for Finished Pharmaceuticals)
    • EU GMP Annex 1 (manufacture of sterile medicinal products)

    Typical usage ratio

    • Formulations typically require 10 mg/mL, with bulk solution concentrations adjusted for specific patient-use presentations; manufacturers optimize final buffer composition based on established pharmacopoeia monographs.

    Downstream process integration

    • The material is dissolved and adjusted in purified water with sterile excipients, filtered to 0.22 μm, filled into glass vials or ampoules, sealed, and terminally sterilized; manufacturers implement in-process controls for pH and assay before batch release.

    Final product types

    • Single-use diagnostic injection vials (10 mg/mL, 1 mL or 10 mL)
    • Multi-use ampoules (clinical diagnostic kits)
    • Combination trial kits for hospital neurology units

    2. Bulk Sterile API Supply for Pre-Filled Syringe Production

    Large-scale syringe manufacturers procure Edrophonium Chloride as a sterile active input for assembly-line filling of pre-filled diagnostic syringes. This production stream demands pharmaceutical-grade material with controlled particle size and low bioburden, supporting high-throughput, automated dosing lines in GMP-regulated facilities. The process integrates the material during solution compounding, monitored for trace impurities and endotoxins, followed by automated syringe assembly and rigorous quality batch testing. Manufacturers must validate aseptic processing, in-line monitoring, and labeling for traceability.

    Industry compliance standards

    • European Pharmacopoeia (Ph. Eur., Monograph 01/2011:1049)
    • FDA 21 CFR Part 211 for injectable devices
    • ISO 13485 and ISO 11607 for medical device packaging
    • ICH Q3A/B for impurity profiles

    Typical usage ratio

    • Concentrations from 10 mg/mL to 20 mg/mL, tailored to syringe volume (1–5 mL) and regional regulatory dosage limits; manufacturers adapt filling volumes per clinical protocol.

    Downstream process integration

    • Sterile concentrated solutions are delivered in bulk, entering compounding tanks prior to in-line dilution, mixing, automated syringe filling, terminal or filter sterilization, and individual unit labeling.

    Final product types

    • Pre-filled syringes for hospital neurology assays
    • Diagnostic kits for rapid bedside testing
    • Ready-to-use clinical diagnostic packs

    3. Research-Grade Reference Material for Laboratory QC and Validation

    Chemical and biopharmaceutical labs utilize Edrophonium Chloride as a certified analytical reference standard for method development, system suitability testing, and in vitro functional assays. Manufacturers supply highly pure, batch-verified material with defined impurity limits, tailored for spectrometric calibration, quality control, and validation of diagnostic equipment. Laboratories require precise lot-to-lot consistency and full documentation for traceability within analytical validation protocols.

    Industry compliance standards

    • ISO/IEC 17025 for laboratory testing and calibration
    • USP General Chapter <11> Reference Standards
    • Analytical Quality by Design (AQbD) principles
    • Good Laboratory Practice (GLP) regulations (OECD, FDA)

    Typical usage ratio

    • Reference material use is application-dependent; typical working solutions range from 100 μg/mL to 1 mg/mL, adjusted per validated analytical protocol (HPLC, UV-Vis, enzymatic assays).

    Downstream process integration

    • The pure API is weighed and dissolved in analytical-grade solvents, aliquoted for calibration standards, spiked into control matrices, and used for instrument method setup and QC checks.

    Final product types

    • Certified reference standards for in-process QC
    • Lab test samples for instrument calibration
    • Validation batches for clinical diagnostic assay kits

    4. Intermediate Compound in Secondary API Synthesis and Impurity Profiling

    Certain pharmaceutical manufacturers use Edrophonium Chloride in secondary synthesis protocols for impurity profiling, metabolic pathway mapping, or as a reactive intermediate in closely related quaternary ammonium analog development. Its defined structure and quaternary ammonium group make it suitable for use as a synthetic handle in downstream R&D and pilot-scale preparation, requiring adherence to established material transfer and documentation procedures across multi-site syntheses.

    Industry compliance standards

    • ICH Q7 “Good Manufacturing Practice for Active Pharmaceutical Ingredients”
    • Ph. Eur. Section 5.10 for related substances
    • FDA DMF (Type II) requirements for intermediates
    • Internal SOPs under company QA/QC systems

    Typical usage ratio

    • Batch chemists employ concentrations from 0.1 to 2.5 molar equivalents depending on synthetic route; excess is minimized for downstream purification. Ratios are calculated precisely to limit formation of side products and trace residuals.

    Downstream process integration

    • Material enters at the defined synthetic step, is reacted with designated co-reactants under controlled temperature and pH, followed by workup, purification, and impurity isolation as required by research targets.

    Final product types

    • Characterized synthesized impurities for pharmaceutical reference
    • Metabolic pathway standards for toxicology studies
    • Intermediate compounds for downstream API development
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    Certification & Compliance
    More Introduction

    Introducing Edrophonium Chloride: Quality from the Manufacturer’s Perspective

    Our Journey with Edrophonium Chloride

    For over two decades, our facility has specialized in the production and refinement of Edrophonium Chloride, establishing a level of understanding that only comes from hands-on experience. Every step, from sourcing raw materials to overseeing the last stage of crystallization, reflects years of technical growth and direct industry feedback. We see Edrophonium Chloride as far more than a line item or technical specification; it represents the sum of deliberate choices, consistent quality control, and continuous improvement. Our team knows the demands placed on pharmaceutical-grade chemicals better than anyone whose only role is distribution. We can speak to the real challenges in achieving purity, maintaining stability, and supporting stringent industry expectations.

    Model and Specifications

    Within our catalog, Edrophonium Chloride appears under model EH2010, refined specifically for pharmaceutical, biochemical, and diagnostic applications. We produce this compound in crystalline powder form, always striving for the clear, white consistency that signals proper crystallization and minimal impurity. Every batch undergoes High-Performance Liquid Chromatography testing, and we maintain a consistent assay level upwards of 98.5%. Moisture levels typically remain under 1.0%, and we keep heavy metals well below the detection limits set by ICH guidelines.

    Particle size can influence some end-user outcomes, so we work with customers to match their functional requirements, using fine mesh screens and regular sample analysis. The pH of a standard 1% solution stands reliably between 4.0 and 5.5. These aren’t just numbers to us—they reflect a history of methodical adjustments, technical consultation, and persistent laboratory assessment.

    Applications and Industry Relevance

    Our customers in the clinical diagnostics field depend on Edrophonium Chloride for its role as a short-acting cholinesterase inhibitor. Its primary use revolves around diagnosis of myasthenia gravis and related neuromuscular disorders. This compound’s rapid onset and specific mechanism make it suitable for procedures such as the Tensilon test, where immediate results drive crucial patient decisions.

    In our experience, even modest fluctuations in impurity profiles or moisture content can undermine the predictability and interpretability of these tests. That’s why we devote significant resources to real-time moisture analysis, rapid batch release, and ongoing training in analytical chemistry. We’ve worked directly with hospital purchasing teams, QA managers, and laboratory staff who report the practical downstream impact of a consistent source—reduced troubleshooting, fewer invalid tests, and smoother integration with automated instruments.

    Some projects demand Edrophonium Chloride for research into neurophysiology or as a tool in drug screening platforms. Here, the purity and traceability of the starting material play just as important a role as explicit regulatory compliance. We document every raw material source, analytical result, and storage condition, prioritizing transparency so our customers never need to guess at the provenance or composition of what they receive.

    What Sets Us Apart from Resellers and Distributors

    Makers of Edrophonium Chloride hold a perspective that outside channels rarely afford—one born from the day-to-day nuances of batch-to-batch variation, synthesis scale-up, and tight regulatory controls. Because we oversee synthesis from precursor selection through to final purification and drying, we know the drivers of product integrity.

    Resellers and intermediaries often advertise compliance or attractive price points, but these stop short of the knowledge that comes with troubleshooting an unexpected minor impurity or solving yield inconsistencies during larger campaigns. We can anticipate lot-to-lot behavior, quickly identify off-spec trends, and adapt our manufacturing process before problems reach the finished vial or hospital shelf.

    Our in-house network of analytical chemists and process engineers documents every anomaly and improvement, feeding small refinements back into daily routine. Beyond batch release certificates and technical data sheets, our long-term customers appreciate the access to real-time technical support—if a question arises mid-project, someone from our team can dig into the original production records and pinpoint root cause. We never outsource oversight because we know each step’s significance firsthand.

    Differences from Other Products and Why They Matter

    Within the universe of cholinesterase inhibitors and neuromuscular diagnostic agents, Edrophonium Chloride distinguishes itself through its rapid onset and short action. Unlike analogs such as Physostigmine or Neostigmine, edrophonium’s pharmacokinetics minimize lingering systemic effects. This makes it the preferred choice in urgent diagnostic protocols where clear, reversible inhibition is needed. Our facility pays particular attention to lot uniformity, minimizing the batch-to-batch drift in physical traits—such as grain size or flow behavior—that so often complicate automated dispensing or dosing precision.

    Users sometimes ask about the difference between product grades marketed as “pharmaceutical” versus “analytical” or “laboratory” grade. We see these distinctions as more than regulatory language. Pharmaceutical grade at our plant comes only after additional purification steps, expanded impurity testing (not just for known by-products, but for contaminants introduced through equipment or packaging), and comprehensive microbiological monitoring. Rigorous environmental monitoring keeps both airborne and surface contamination out of the workflow. This approach increases operational complexity but delivers product that stands up to regulatory inspection anywhere in the world.

    Other companies might offer an Edrophonium Chloride variant with similar chemical purity numbers, but overlook secondary characteristics that influence real-world use—such as stability under humidity, compatibility with automated liquid handlers, or resistance to clumping under warehouse conditions. We run forced degradation studies, simulate storage and shipping environments, then adjust drying protocols or packaging formats as needed. Through countless feedback loops and QA reviews, our material remains stable, easy to handle, and robust to variable storage conditions.

    Regulatory Commitment and Quality Assurance

    Modern pharmaceutical supply chains demand transparency, traceability, and agile responsiveness. Our history in Edrophonium Chloride manufacturing means we design our processes to exceed global pharmacopeia standards—United States Pharmacopeia, European Pharmacopoeia, Japanese Pharmacopeia—and numerous country-specific requirements. This isn’t a paper chase; it’s daily practice. Our validation team audits every protocol update, records every deviation, and ensures any corrective or preventive action gets tracked from root cause to final implementation.

    Each batch leaves our premises with a complete Certificate of Analysis, and we invite regular customer audits to see how production aligns with regulatory expectations. Our environmental monitoring, equipment calibration, and operator training all match standards set by health authorities worldwide. In-house batch records extend years back, providing evidence-based confidence during any regulatory review or customer inquiry. Our feedback system identifies not only direct complaints but subtle process improvement opportunities—a faulty shipment, reported during inspection, gets logged and analyzed, adjusting documentation or process parameters to prevent future recurrence.

    Supporting Customers Beyond the Order

    Those of us who work in chemical manufacturing understand how easily a purchasing decision can cascade into daily lab complications if the source material introduces variables. From the outset, we commit not just to shipping a certified product but to understanding every context where it matters. For customers switching from a different supplier, we support method bridging, comparative analysis, and side-by-side studies. Our scientists share reference material, trial lots, and interpretation of analytical results, closing the gap between our documentation and your operational needs.

    Because we monitor our supply chain closely, sudden disruptions—raw material shortages, logistic complexities, new compliance mandates—get assessed for risk and communicated quickly. During the pandemic, our production scale and inventory strategy shielded key customers from major delays. We prioritized batch allocation for ongoing therapeutic programs, clinical trials, and hospital contracts over speculative trading. Open communication established trust, and our documentation simplified customs clearance and importer requirements even under shifting regulatory environments.

    Challenges We’ve Faced—And Solutions

    Chemical production never operates in a bubble, and no campaign is free from difficulty. Over time, facility upgrades, raw material shortages, and regulatory updates have all threatened to disrupt supply. To address these, we sought upstream raw material partnerships well before supply chains became a topical industry discussion. Multiple qualified vendors and local supply agreements help keep key precursors on hand, reducing risk from single-source dependency.

    In 2017, a routine audit revealed a trace solvent impurity trending slightly above our established action limit. Immediate cross-functional meetings led to a process tweak, and new on-line gas chromatographs now inspect every lot in real time. Problems like this remind us that proactive investment in equipment, training, and documentation pays dividends for years. We regularly schedule process simulation runs under worst-case temperature, humidity, and operator variation to validate real-world product resilience.

    Packaging isn’t an afterthought either, as poorly chosen desiccants or vial materials can drive subtle shifts in material quality over long distribution times. By adjusting the blend of barrier films and moisture scavengers, we cut reported clumping cases by over 90% during high summer months. We invite feedback from customers experiencing difficulties—trace powder loss during dispensing, for example—and invest in pilot-scale packaging trials to address every reported concern.

    Continuous Improvement and Looking Forward

    The production of critical pharmaceutical building blocks like Edrophonium Chloride rarely rewards complacency. Each year brings new analytical techniques, regulatory trends, and shifting customer applications. We invest in partnerships with university labs, regulatory consultants, and instrument manufacturers to identify best practices before they filter through the broader industry. This spirit of continuous improvement shapes our hiring, incentivizes technical training, and keeps us in conversation with our peers, clients, and vendors alike.

    We participate in regional and international chemical safety initiatives, sharing process control learnings and responding to emergent standards on impurity management, traceability, and supply chain security. Our facility’s energy usage, waste management, and solvent recovery protocols now reflect commitments to sustainability and resource conservation, directly linking product stewardship with long-term customer trust.

    Customers sometimes ask about planned advances—upgraded product grades, cleaner packaging, tighter specifications. We see every product review, customer audit, or regulatory challenge as insight into where to invest next. Current projects include reducing environmental impact through optimized synthesis and advancing continuous monitoring systems to shrink the gap between observed and reported material performance.

    Direct Engagement Means Real Answers

    As the manufacturer, our responsibility extends beyond the bulk shipment of Edrophonium Chloride. We stake our reputation on consistent quality, reliable documentation, and deep understanding of use case realities. We’ve seen firsthand that minor compromises at the production stage—whether in reagent grade, environmental control, or operator training—echo through the clinical, research, and manufacturing environments.

    Technical teams within our organization routinely field nuanced queries from hospital directors, R&D chemists, and procurement specialists. We don’t just read out a product spec—we walk partners through onsite audits, demonstrate analytical equipment, and discuss historical process changes that transformed our outcomes. We have confidence in what we ship because we know each lot, each day, each challenge behind it.

    Our story with Edrophonium Chloride is ongoing, a process of knowledge and detail, and we welcome opportunities to share that insight with any user whose work depends on trustworthy supply and proven performance. If confidence in material quality matters for your application, direct conversation with the manufacturer makes the difference. We put that belief into every shipment, every consultation, and every step of our evolving process.