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Enflurane

    • Product Name Enflurane
    • Alias Ethrane
    • Einecs 204-826-4
    • 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
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    Specifications

    HS Code

    288074

    Generic Name Enflurane
    Drug Class Inhalational anesthetic
    Chemical Formula C3H2ClF5O
    Molecular Weight 184.5 g/mol
    Boiling Point 56.5°C
    Appearance Clear, colorless liquid
    Route Of Administration Inhalation
    Mechanism Of Action Enhances inhibitory neurotransmission via GABA receptors
    Minimum Alveolar Concentration 1.68% in adults
    Metabolism Primarily hepatic, with some renal excretion
    Brand Name Ethrane
    Storage Conditions Store at controlled room temperature, away from light

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

    Packing & Storage
    Packing Enflurane is typically packaged in a 250 mL amber glass bottle with a tamper-evident seal, labeled for anesthetic use.
    Shipping Enflurane is shipped in tightly sealed, corrosion-resistant cylinders or containers, designed to prevent leaks and exposure. It is classified as a hazardous material and must be labeled according to regulatory guidelines. Transport requires temperature control, secure packaging, and adherence to safety and legal standards for volatile anesthetic gases.
    Storage Enflurane should be stored in tightly closed containers, protected from light, at controlled room temperature (15-30°C or 59-86°F). It should be kept away from heat sources, open flames, and incompatible materials such as oxidizing agents. Proper ventilation is necessary to prevent vapor accumulation. Store in a secure area, accessible only to trained personnel, and follow all regulatory guidelines for hazardous chemicals.
    Application of Enflurane

    Applications of Enflurane in Industrial Manufacturing

    As a specialized producer of enflurane, we supply this high-purity inhalational anesthetic for industrial and pharmaceutical downstream applications requiring tightly controlled quality, consistent physical characteristics, and reliable traceability throughout the supply chain. Our manufacturing process ensures compliance with stringent international standards, supporting large-scale customers operating in advanced healthcare supply production environments. Below, we outline several focused industrial application scenarios where enflurane serves as an essential raw material, with attention to specific compliance frameworks, dosing ranges, integration stages, and representative end products.

    1. Bulk Inhalation Anesthetic Formulation for Human Surgical Use

    Large-scale anesthesia manufacturing facilities incorporate enflurane as a principal active ingredient in the formulation of volatile anesthetic products for clinical settings. These facilities uphold regulatory specifications across multiple geographies, maintain validated processes to ensure contamination prevention, and perform full batch traceability from raw material reception through finished vial or bottle packaging. Enflurane’s introduction occurs in tightly controlled mixing tanks, where temperature, humidity, and nitrogen blanketing are strictly monitored to preserve chemical purity and minimize degradation. Downstream, the formulated product is filled into glass ampoules or aluminum bottles under aseptic conditions and subjected to extensive quality release, including gas chromatography and moisture content analysis.

    Industry compliance standards

    • United States Pharmacopeia (USP)
    • European Pharmacopoeia (Ph. Eur.)
    • Japanese Pharmacopoeia (JP)
    • Good Manufacturing Practice (GMP, ICH Q7)

    Typical usage ratio

    • 99.5–100% (neat), filled directly with minor stabilization additives as required by pharmacopoeia monographs

    Downstream process integration

    • Bulk transfer to formulation tanks → sterile filtration → filling into primary packaging under inert atmosphere → crimp sealing

    Final product types

    • Volatile anesthetic liquid bottles for operating room vaporizers
    • Glass ampoules for clinical anesthesia delivery systems

    2. Veterinary Surgical Anesthetic Preparation

    Veterinary pharmaceutical producers employ enflurane to formulate inhalation anesthetic agents for use in the surgical treatment of companion animals, livestock, and laboratory research species. These downstream manufacturers must adhere to veterinary drug regulations that differ from human medicines and may tailor enflurane-based solutions for species-specific delivery systems. Handling takes place in dedicated lines to prevent cross-contamination with other veterinary active substances, and rigorous documentation accompanies each stage. For veterinary gases, formulated products undergo serial filtration before packaging in tamper-evident, animal-health-labeled containers.

    Industry compliance standards

    • United States Code of Federal Regulations (CFR) Title 21, Part 514 (Veterinary Drugs)
    • European Medicines Agency (EMA) Veterinary Medicinal Products Regulation (EU) 2019/6
    • Australian Pesticides and Veterinary Medicines Authority (APVMA) Standards
    • ISO 9001 for Quality Management Systems in Animal Health

    Typical usage ratio

    • 98.0–100% (as main active), adjusted based on species-specific formulation and national registration guidelines

    Downstream process integration

    • Measured dispensing into veterinary formulation vessels → blending with propellants or stabilizers if indicated → sterile packaging → veterinary labeling line

    Final product types

    • Inhalational anesthesia vials for companion animal use
    • Large-volume veterinary anesthesia bottles for livestock clinics
    • Research-grade anesthesia supplies for laboratory animal facilities

    3. Calibration Standards Production for Medical Gas Analyzers

    Specialty gas manufacturers utilize enflurane as a reference substance in the preparation of calibration standard mixtures for hospital and laboratory anesthesia monitors. Producing these standards requires weighing and blending pure enflurane in precisely metered concentrations with certified carrier gases such as nitrogen or medical air, using gravimetric or volumetric blending under cleanroom conditions. Batches undergo traceable certification against NIST and EU reference materials, and every cylinder is individually pressure-checked, labeled, and delivered with analysis documentation for use in recalibration protocols by original equipment manufacturers (OEMs) and clinical engineers.

    Industry compliance standards

    • ISO 6141:2015 (Requirements for reference materials – Gases)
    • National Institute of Standards and Technology (NIST) traceability for calibration gas standards
    • EN ISO 13485:2016 (Medical Devices – Quality Management Systems)
    • Transport regulations: ADR/RID, IATA DGR for packaged gases

    Typical usage ratio

    • 0.5–7% (by volume), depending on analyzer calibration range; higher concentrations supplied for OEM reference; blends tailored to end user specification

    Downstream process integration

    • Gravimetric or dynamic blending of enflurane with carrier gas → quality control via gas chromatography → sterilized bottling in specialty cylinders → certification documentation

    Final product types

    • Medical gas calibration cylinders for anesthesia monitoring systems
    • Certified reference gas kits for medical device OEMs

    4. Analytical Reagent Formulation for QC Laboratories

    Producers of laboratory reagents and chemical standards rely on enflurane as a component in the manufacture of verification solutions, proficiency testing standards, and method validation samples. Delivered in sealed vials or ampoules, reagent-grade enflurane supports internal and external quality controls for analytical device calibration, regulatory compliance testing, and cross-laboratory proficiency assessments. Downstream manufacturers document every lot against reverse traceability to our production schedule and maintain detailed chain-of-custody records for regulated environments.

    Industry compliance standards

    • ISO 17025:2017 (General requirements for the competence of testing and calibration laboratories)
    • ISO Guide 34 (Reference Material Producers)
    • OECD Good Laboratory Practice (GLP) principles
    • Relevant country-specific accreditation bodies (e.g., CNAS in China, A2LA in USA)

    Typical usage ratio

    • 0.1–5% (in standard solution formulation), set according to instrument sensitivity and intended test method; precision batching ensures repeatability

    Downstream process integration

    • Direct addition to solvent matrix in fume hood → homogenization under controlled temperature → aliquoting into pre-cleaned analytical vials → batch labeling and COA generation

    Final product types

    • Laboratory calibration standards for chromatographic equipment
    • Proficiency testing ampoules for regulatory and interlaboratory comparison
    • Analytical verification kits used in pharmaceutical QC
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    Certification & Compliance
    More Introduction

    Enflurane: Quality Inhalation Anesthetic Direct from the Manufacturer

    Decades of Experience with Inhalation Anesthetics

    We have seen the field of inhalational anesthesia grow from basic ether and chloroform to today's modern, safer agents. Through regular improvements and direct, hands-on involvement in our facilities, Enflurane has become a key part of what we offer healthcare and veterinary providers. Having worked closely with suppliers, hospitals, and researchers for years, we have learned that purity, clarity, and reliability aren't just words—they are daily requirements.

    The Enflurane We Produce

    Our Enflurane carries the chemical name 2-chloro-1,1,2-trifluoroethyl-difluoromethyl ether. In our plants, we focus on absolute purity and consistency, maintaining a minimum assay of 99.9% verified batch-by-batch through multiple analytical techniques such as gas chromatography and infrared spectroscopy. We review all raw materials and process conditions ourselves, not relying on upstream suppliers to verify quality.

    We supply Enflurane in liquid form, clear and colorless, with a faint, sweet odor. Every batch is packed under inert atmosphere using only stainless steel or coated containers, eliminating risk of contamination or product breakdown. We use steel tanks, glass bottles, and PTFE-lined seals to avoid leaching and offgassing. Any deviation from our specifications leads to rejection—not rework.

    Why We Continue to Make Enflurane

    Critical care environments require inhalation anesthetics with predictable pharmacokinetic profiles. Enflurane delivers the level of reliability anesthetists depend on for precise depth control and smooth recovery in both human and animal procedures. We receive feedback directly from teaching hospitals and large veterinary centers—some specialties prefer Enflurane for its slower uptake compared with Isoflurane, which gives them more flexibility in tailored procedures. Despite new products, there are still procedures where Enflurane’s properties are preferred.

    A textbook property of Enflurane is its relatively low blood-gas partition coefficient (about 1.8), which enables manageable induction and emergence times without sudden spikes in anesthetic depth. Compared to agents like Methoxyflurane, users report more predictable control over levels. The slightly higher solubility than Isoflurane or Sevoflurane provides seasoned clinicians the ability to pace anesthetic delivery, which can be helpful in longer surgeries or in research settings where stability outweighs speed.

    Pharmaceutical-Grade Consistency

    We rarely discuss our batch records outside regulatory audits, but consistency is an obsession for us. Throughout synthesis, we monitor not just purity but trace residue of related ethers, halogenated byproducts, and residual solvents. Any spike above set limits means the batch stays in quarantine. The result: clinicians and procurement staff know what to expect with each order. No two production runs are left to chance.

    Our containers undergo periodic residue checks and pressure testing. We use tamperproof seals that we developed based on years of shipping experience worldwide. Most defects—micro-leaks, improper seals—get caught in our in-house inspection line long before any product leaves our plant. This hands-on process minimizes confusion and returns, reducing headaches for end users.

    Direct Insights from Manufacturing Experience

    Having been involved in the sourcing, handling, and transport of sensitive chemicals, we understand that stability doesn't come from specifications alone—it comes from careful attention as liquids move from reactors to fillers, and as filled drums travel by road, air, or sea. Temperature swings and improper handling can break down even the most robust anesthetic. Based on lessons learned over decades, we maintain strict controls on storage conditions, and we train logistics partners accordingly. Any container showing signs of condensation or off-odor never moves forward. We have invested in data loggers and real-time tracking to keep shipments labelled and secured.

    Comparison with Other Anesthetics

    Clinicians sometimes ask us, "Why continue to offer Enflurane with so many alternatives on the market?" Having observed its use across operating rooms and research centers, we see real-world reasons. Compared to Isoflurane (the primary alternative in many markets), Enflurane’s lower volatility allows for gentler titration, which suits complex cases involving geriatric or cardiac patients. While some facilities favor Sevoflurane for pediatric or ambulatory use due to faster elimination, others rely on Enflurane for consistency and cost control in longer, routine surgeries.

    Methoxyflurane, long withdrawn in many regions, is considerably more nephrotoxic, whereas Halothane—once dominant—has fallen out of favor due to risks of hepatotoxicity. Enflurane stands out for its safety profile, provided users follow protocols regarding CO2 absorption and avoid contraindicated patient populations. Our technical support teams have worked alongside hospital pharmacy staff to minimize risk in high-use settings. This day-to-day problem-solving has shaped every design change at our site, from drum size to labeling.

    Addressing Safety and User Needs

    Over years manufacturing and supplying Enflurane, we’ve heard the same story from end users: safety comes down to predictability. That's why our lot release program covers more than a COA printout. During QA, our technicians pull containers off the line to run extra checks for impurities such as difluoromethoxy- or trichloromethoxy-containing side products. We participate in regular cross-lab verification with independent reference labs, and we keep reference standards in our plant for spot-checks.

    As a direct manufacturer, we stand behind every liter. Whenever users have raised concerns about minor container flaws or batch differences, our technical and sales engineers have made onsite visits to trace the cause. We do not ship from distributors or untraceable depots; our shipments leave only from our licensed facilities, using vehicles trained in handling volatile liquids. These habits have helped us catch rare problems early and avoid supply chain surprises.

    Supporting Users Beyond Supply

    Some of the most telling moments we’ve witnessed came during global shortages, when customers asked for partial orders or off-schedule deliveries to keep operating rooms running. Because we run our own production calendar, we have flexibility to adapt run times, scale up shifts, or allocate stocks as needed. During the early days of epidemic events, our sites stayed online, working in shifts to keep supply commitments.

    We keep stocks of empty bottles, labels, closures, and shipping materials on hand to avoid bottlenecks. Our logistics managers work with port agents to prioritize urgent cargo. These measures have given us a reputation as a dependable source, even in unstable markets.

    Solutions for Clinical and Research Use

    Universities and preclinical labs need assurance that the agent in their vaporizer matches published reference standards. We include documentation of source, batch, and analysis with every shipment. For long-term studies, we keep retains for sample comparison. Custom fill sizes or packaging types can be arranged, based on feedback from veterinary and research teams needing to minimize wastage or fit specific device ports.

    For clinical settings, we work closely with pharmacy compounding teams to ensure compatibility with current devices and absorbers. We offer detailed guidance on shelf life and storage—based on measured stability data rather than extrapolated estimates. If a facility experiences unfamiliar instrument readings or has vaporizer calibration concerns, our technical support lines connect them straight to our on-site chemists or QC officers, not through a call center.

    Regulatory Assurance at the Source

    Our regulatory compliance is based on direct, regular inspections and independent audits, not just paperwork. We've participated in regional and international pharmacopoeia reviews, adapting labeling, documentation, and handling procedures as standards evolve. During country-specific approvals, we stay engaged until licensing authorities complete their review—not pushing responsibility onto shippers or customs brokers. Our documentation packages reflect every stage, from chemical synthesis to filling and shipment, making traceability end-to-end.

    Storage and Handling Insights from Daily Experience

    Enflurane requires careful handling to maintain potency and purity. Over the years, we've seen most shipping issues resolve through well-trained staff and straightforward storage policies. We recommend cool, dry, well-ventilated storage away from heat or acids. Keeping track of opening dates and minimizing exposure to air reduces peroxide formation. Many problems traced in hospital settings came down to leaving uncapped bottles on carts or using old absorbers. By documenting and sharing these real-world practices, we help facilities get consistent results and cut down on waste.

    Ongoing Innovation and Feedback Loop

    Our R&D group pursues ongoing improvements—not to chase trends but to address feedback from end users. For example, one recent upgrade in our facility replaced standard gaskets with chemically inert PTFE linings, eliminating subtle odor changes in shipped material. After a series of requests for improved anti-tamper measures, we commissioned a local machine shop to build new sealing equipment, rolling it out within months across all sizes.

    Our engineers take part in routine meetings with anesthesiology groups, hospital pharmacists, and animal care specialists, gathering direct input. Changes to product configuration, packaging, or documentation are often based on real-world needs, not just regulatory mandates. We also share anonymized stability data and key findings in annual user workshops to keep customers informed of best practices and product evolution.

    Environmental Considerations in Manufacturing and Use

    Producing halogenated ethers responsibly requires investment in pollution control and waste management. We capture and neutralize process emissions, using activated carbon, high-efficiency scrubbers, and multi-stage separation lines. Waste streams containing even trace Enflurane residues receive batch-specific destruction, with every drum tracked from production through to final neutralization or incineration.

    We maintain voluntary partnerships with environmental consultants to monitor local impacts and participate in community feedback sessions. While Enflurane’s ODP (ozone depletion potential) remains very low compared to legacy anesthetics, we keep working with our raw material suppliers and logistics partners to further cut down transport emissions. As regulatory requirements change, our commitment to responsible chemistry ensures our processes adapt without sacrificing supply reliability or product integrity.

    Why Direct Source Matters

    Purchasing directly from us—the actual manufacturer—means real-time information on product status, batch availability, and technical support. We've witnessed confusion and risk arise when users unknowingly buy from unapproved intermediaries or relabeled stocks. Direct channels keep supply chains transparent and ensure accountability. If a problem arises, our customers reach experienced technical staff who worked on the batch, not distant resellers.

    We remain committed to maintaining open dialogue. Our facility doors remain open, not just to auditors, but to clinicians, technical buyers, and academics. We regularly organize site visits for client teams, allowing them to see first-hand our process controls, storage protocols, and QA workflow.

    Continuous Learning, Consistent Results

    Decades of experience producing Enflurane have taught us that quality results from involvement at every stage. Each improvement in synthesis or packaging comes from understanding how real people use, store, and handle the product. By keeping feedback loops open, empowering staff to intervene at all steps, and holding to our longstanding standards, we keep Enflurane reliable for healthcare professionals worldwide.

    With every shipment, we share not just a product but the benefit of years of accumulated know-how from our chemists, operators, and supply staff. We encourage users—whether hospital, research center, or veterinary practice—to connect with our technical team. Real discussions drive better products and better outcomes, and we remain ready to support every request with the direct expertise only a manufacturer can provide.