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Etodolac Methyl Ester

    • Product Name Etodolac Methyl Ester
    • Alias ETMD
    • Einecs 893620-89-8
    • 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
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    Specifications

    HS Code

    278962

    Chemical Name Etodolac Methyl Ester
    Molecular Formula C18H21NO3
    Molecular Weight 299.37 g/mol
    Cas Number 159744-42-2
    Appearance White to off-white solid
    Solubility Slightly soluble in water; soluble in organic solvents
    Storage Conditions Store at room temperature, away from moisture and light
    Purity Typically ≥98% (depending on supplier specification)
    Chemical Class Nonsteroidal anti-inflammatory drug (NSAID) derivative
    Iupac Name methyl 1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indole-1-acetate
    Application Primarily for research and chemical synthesis use

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

    Packing & Storage
    Packing Etodolac Methyl Ester, 10g, sealed in an amber glass bottle with tamper-evident cap, labeled with product details and safety information.
    Shipping Etodolac Methyl Ester is shipped in tightly sealed containers, protected from moisture, excessive heat, and direct sunlight. All packaging complies with chemical safety standards and includes clear labeling. Shipping is conducted via qualified carriers, following all transportation regulations for laboratory chemicals to ensure product integrity and safe delivery.
    Storage Etodolac Methyl Ester should be stored in a tightly sealed container, protected from light and moisture. Keep it in a cool, dry place, ideally at room temperature (20–25°C), away from sources of ignition and incompatible substances such as strong oxidizers. Ensure adequate ventilation in the storage area and restrict access to authorized personnel only. Proper labeling and safety precautions are essential.
    Application of Etodolac Methyl Ester

    Applications of Etodolac Methyl Ester in Industrial Manufacturing

    We supply Etodolac Methyl Ester directly to specialized pharmaceutical and chemical plants. This active ingredient serves as a critical intermediate for selective downstream markets, where precise formulation, process control, and regulatory compliance determine final product success. Below are recognized industrial application areas supported by clear process and quality requirements.

    1. API Intermediate Manufacturing for Analgesics

    Etodolac Methyl Ester is primarily used to synthesize etodolac, a non-steroidal anti-inflammatory drug (NSAID) frequently incorporated into finished prescription tablets and capsules. Bulk API manufacturers convert the ester via controlled hydrolysis followed by further transformation to the active acid form. This intermediate stage requires accurate stoichiometry and real-time QC monitoring for pharmaceutical-grade output. Process traceability and impurity control in this step are essential for meeting downstream API release specifications under global pharmaceutical market regulations.

    Industry compliance standards

    • ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
    • European Pharmacopoeia 11.0 monographs for API intermediates
    • 21 CFR Part 210/211 (FDA cGMP for APIs)
    • China Drug Administration Provisions on Drug Production

    Typical usage ratio

    • Etodolac Methyl Ester: 95-99% in synthesis batch; adjusted by process mass yield and downstream target purity
    • Hydrolysis agents and solvents: <5%, modulated based on batch scale and reactor capacity

    Downstream process integration

    • Direct input to API synthesis after methylation of precursor acid
    • Purification runs prior to ester hydrolysis and conversion to primary amine derivatives as needed
    • Continuous in-process monitoring for ester group content and residual solvents

    Final product types

    • Etodolac API (Active Pharmaceutical Ingredient, USP/Ph. Eur./JP grades)
    • Bulk pharmaceutical intermediates for licensed drug manufacturers

    2. Reference Standard Preparation for Analytical Laboratories

    Quality control and analytical laboratories within the pharma sector purchase high-purity Etodolac Methyl Ester to formulate internal reference standards. These standards enable validated calibration and impurity profiling for routine HPLC, GC-MS, and NMR analysis during regulatory testing. Consistent material properties and detailed CoA documentation are required for successful batch certification and regulatory submission support.

    Industry compliance standards

    • ISO/IEC 17025:2017 Laboratory Competence
    • USP General Chapter <11> Reference Standards
    • European Pharmacopoeia General Notices on Analytical Reference Substances

    Typical usage ratio

    • Etodolac Methyl Ester: 0.1-10 mg per calibration solution
    • Matrix solvents (e.g., acetonitrile, methanol): 99%+ for standard solution preparation

    Downstream process integration

    • Direct dissolution in analytic-grade solvents as primary/secondary reference solution
    • QC system suitability testing for each analytical run per pharmacopoeial chapter

    Final product types

    • Certified analytical reference standards
    • Pharmacopeial working standards for in-house QC

    3. Process Development and Route Optimization in Pharmaceutical R&D

    Pharmaceutical R&D divisions use Etodolac Methyl Ester to investigate new synthetic routes, process optimization for etodolac and analogues, and scalable batch process transfer from lab to pilot plant. Accurate composition and reactivity facilitate kinetic studies, impurity pathway mapping, and cost optimization in early-stage development. Innovations at this stage may feed into patent applications and yield improvements for commercial API production.

    Industry compliance standards

    • Good Laboratory Practice (GLP, OECD Principles)
    • Patent documentation standards (WIPO, USPTO)
    • ISO 9001:2015 for Research & Development Management Systems

    Typical usage ratio

    • Trial batch scale: 1-10 g Etodolac Methyl Ester per experiment
    • Process optimization: 50-200 g for pilot-scale method validation

    Downstream process integration

    • Introduction at methyl esterification step or as isolated intermediate for route flexibility assays
    • Sampling for kinetic and impurity analysis during each step of experimental workflow

    Final product types

    • Pilot batch API samples
    • Patent and regulatory submission samples
    • Technical data packages for technology transfer

    4. Quality Control System Validation for Bulk API Producers

    Contract manufacturing organizations and major API producers rely on Etodolac Methyl Ester to maintain continuous quality control in ongoing production runs. Batches tested for identity, purity, and specific methyl ester content support GMP compliance and consistency for export to regulated markets. Each consignment must trace to a qualified supplier with full batch audit trails and controlled release protocols for regulatory acceptance.

    Industry compliance standards

    • ICH Q6A Specifications for New Drug Substances & Products
    • GMP Certificate of Suitability to the Eu. Pharmacopoeia Monographs
    • FDA DMF (Drug Master File) reference for supply chain traceability

    Typical usage ratio

    • QC reference use: 10-100 mg per in-process quality control check
    • Batch release testing: Use based on frequency and scope of ongoing API production scale

    Downstream process integration

    • Usage in validated analytical HPLC/GC systems for batch testing
    • Stability indicating assays per ICH stability protocols

    Final product types

    • QC-certified etodolac APIs for regulated market supply
    • Batch release documentation for regulatory filings

    5. Fine Chemical Synthesis for Advanced Intermediates

    Chemical manufacturers synthesize advanced etodolac derivatives using methyl ester intermediates as building blocks, such as for custom contract synthesis orders in the pharmaceutical fine chemicals sector. Precise control of reactivity and purity facilitates subsequent coupling, reduction, and chiral separation processes supporting custom molecular architecture by downstream customers. Traceability links each batch to upstream raw material compliance for client audit compatibility.

    Industry compliance standards

    • ISO 9001:2015 Quality Management Systems
    • REACH Registration for chemical intermediates
    • Hazardous Chemical Control Law (PRC) for fine chemicals handling

    Typical usage ratio

    • Synthesis input: 60-98% of stepwise reaction batch depending on target derivative and process design
    • Adjustments based on the stoichiometry for specific substitution or reduction operations

    Downstream process integration

    • Entry as a reactant or protected intermediate for selective synthetic steps
    • Use in batch or continuous flow reactors in fine chemicals manufacturing lines

    Final product types

    • Custom etodolac analogues for pharma discovery
    • Chemical intermediates for further transformation by CDMO partners
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    Certification & Compliance
    More Introduction

    Etodolac Methyl Ester: A Practical Approach from the Manufacturer’s Bench

    Working with Etodolac Methyl Ester in Modern Production

    Every batch of Etodolac Methyl Ester passes through rigorous hands-on monitoring in our facility. This product, developed through a refined methylation pathway, embodies our guiding philosophy: results in the lab translate directly to real-world benefits for our partners. Pharmaceutical intermediates demand both consistency and clarity in their behavior, especially under scale-up. Our own teams go through the full cycle—from raw input checks, through synthesis, to purification. Each stage gets documented, not for bureaucracy’s sake, but for relentless troubleshooting and process improvement.

    Our Etodolac Methyl Ester carries a model code unique to each batch, which lets us track every necessary parameter: reagent lot, reaction profile, purification conditions, and in-process analytical checks. We rely on established spectroscopic and chromatographic methods—NMR, HPLC, IR. The fingerprint is always retained for future reference and cross-validation. This hands-on data forms the basis for batch release, not simply what the paperwork says. Synthetic routes get tweaked as needed, because we’ve seen how slight differences in methylation conditions affect the downstream purity and conversion yields. Consistency isn’t achieved by accident; it’s the result of habit and attention to detail day in and day out.

    Model and Specifications Rooted in Experience

    Our specifications for Etodolac Methyl Ester reflect lessons learned on the factory floor as much as the literature. Over the years, we’ve pushed down residual solvents, handled challenging exothermic points, and reworked purification stages to avoid trace contaminants—like methyl chloride residues or unreacted acid. Purity checks rest at no less than 99%, because any lower risks fouling downstream reactions or producing variable quality in final APIs. Moisture and heavy metal content targets sit comfortably within ICH guidelines, not because they sound impressive on a sales sheet, but because our QC team knows how even microgram quantities can disrupt subsequent chemistry in pharmaceutical plants. The viscosity, color, and solubility profiles get checked against process needs, not just because regulators ask, but because our downstream users get product that runs right through their lines without unexpected downtime.

    Our teams document every challenge encountered: scale artifacts, unexpected side products, tricky batch startups. When we optimize, we focus on robustness. More stable intermediates mean real savings in solvent consumption, fewer filtration headaches, and less rework for everyone down the pipeline—from our reactors, to your process, to the pill on the pharmacy shelf.

    Practical Usage in Pharmaceutical Synthesis

    Etodolac Methyl Ester isn’t a commodity chemical you can just swap for any methylating agent or generic ester. In our facility, each stage leading to the ester gets controlled for temperature ramp, mixing rate, molar ratios, and especially product isolation. We supply this intermediate mostly to pharmaceutical manufacturers engaged in synthesis of non-steroidal anti-inflammatory drugs—often in automated plants running hundreds of kilograms at a time. Their engineering teams demand a product that won’t cause column fouling, emit off-spec volatile organics, or suddenly react differently after a plant shutdown or maintenance.

    Over the past decade, we’ve seen partners move away from less pure or less stable etodolac derivatives. We know firsthand the headaches that ambiguous intermediates create during scale-up, from erratic crystallization to issues with residual methylating byproducts. Such issues don’t just raise compliance flags; they eat into margins by requiring extra waste treatment, more analytical controls, and more batch downtime. Our approach produces methyl esters with predictable profiles every run, saving money and reducing risk not just for the regulatory managers, but also for the chemists and engineers who run the plant floor day in and day out.

    Differences from Other Products: Ground Truth from Production

    Contrasting our Etodolac Methyl Ester with other intermediates isn’t just about quoting finer metrics. The product’s physical consistency, shelf-life stability, and reactivity are the results of repeated direct feedback from process engineers and quality managers who’ve struggled with uncontrolled side reactions and unexpected residue from cruder grades. We’ve invested in tailored equipment—specifically for methyl ester synthesis and purification—so we get clean isolation with minimal side products. In several instances, we’ve run parallel syntheses between our own and competing samples. We adjust for things like solvent grade, drying step sequence, or post-synthesis stabilization. The superior flow through subsequent synthesis steps, reduced need for rework, and fewer customer complaints come from these technical choices—not sales claims.

    Lower-purity versions available in the wider market may seem attractive on paper for low-cost projects, but they end up demanding heavier investments in downstream cleanup and quality troubleshooting. We’ve reviewed competitors’ samples in our own QC lab: GC-FID, LC-MS, and DSC results almost always reveal issues with unknown peaks, repeat batch-to-batch drifting, or color instability upon storage. By locking down our process validation and raw material sourcing, we avoid these pitfalls from the start. The stability profile is so robust that our partners rarely report issues with shipping or extended storage—something not all competitors can say, as temperature shifts can trigger precipitation or decomposition in off-the-shelf material.

    We have avoided certain “shortcut” production methods that can introduce hazardous byproducts or leave behind process-sensitive residues. Running a plant means living with every molecule produced or leftover, so we have engineered our synthesis to minimize exposure and waste. Operators and QC technicians work side-by-side to monitor for any drift, spiking, or purity issues in real time. We don’t just test samples; we live with our product every shift. This knowledge gets baked into every batch released, allowing downstream users room to focus on their own process optimization rather than remediation.

    Supporting Consistent Quality: Reports from Our Plant Teams

    Operators talk about Etodolac Methyl Ester in terms other than numbers. They see the difference in how it moves through the lines, how easy it is to filter, and how it holds up during hot days or power interruptions. No formula or sales brochure stands in for the relief of knowing that today’s batch will behave like last month’s—or last year’s. Plant managers send in feedback after routine audits and after extraordinary events—like transport delays or power failures. The methyl ester holds steady, neither gumming up the machinery nor auto-degrading under moderate thermal exposure.

    These stories underscore our approach: putting knowledge and investment into every step, not just the final check. We’ve walked away from some synthesis routes that produced “good enough” etodolac esters but caused endless problems in filtration, isolation, or later hydrogenation steps. Each small logbook note—‘sticky’, ‘cloudiness’, ‘extra wash needed’—gets addressed in our process reviews. Mistakes and mishaps from years ago hang on the wall as reference, reminding us what not to repeat.

    Handling and Storage: What Years of Practice Teach

    The handling of Etodolac Methyl Ester starts before a drum or drum liner gets filled. Forklift operators, storage managers, and shipping coordinators in our plant work from actual field experience: non-reactive containers, climate-moderated storage, segregated areas for incoming and outgoing materials. We have adopted this method after seeing what happens when batches sit too long, or when packaging choices seem right on paper but fail under real logistics pressures. Every year, we review product stability data not because it’s a compliance box to tick, but because the results translate directly into fewer headaches—for us and our customers.

    Staff in our packaging hall understand that small changes—gasket composition, drum liner thickness, closure torque—impact product protection. They report in real time if an issue comes up: a shipment delayed, a container dented, humidity spike in the warehouse. Problems get logged and acted on, not buried by paperwork. We’ve rolled out training sessions based on actual incidents, which sometimes means scrapping a whole batch to avoid a silent quality drift. Investing the time upfront prevents far bigger losses later on.

    Environmental Impacts and Plant Realities

    Every chemical manufacturer faces growing pressure for sustainable practices. We answer this by attacking waste at every process step and by constantly improving solvent recovery and energy efficiency. Rather than waiting for external pressure, we cut down process effluents, implement chemical recycling, and invest in local wastewater treatment—not for marketing claims, but because we live next to our community and because compliant operations mean fewer unplanned shutdowns and audits. Regular maintenance reduces solvent leaks and accidental releases, saving costs and company reputation in the long run.

    We work directly with our EHS officers to improve cycle efficiency and reduce risk at loading, unloading, and cleaning steps. Each MSS (management of safe systems) review leads to tweaks in batch recipe or equipment cleaning schedules. Chemical waste gets tracked from the reactor to final disposal or recycling. It’s not an afterthought. Production managers and shift leaders vet every tweak: a slight change in quenching or washing procedure ripples through energy use, emissions, and waste management for months afterwards.

    We’ve learned that robust process control does more than safeguard the environment: it builds trust among regulatory agencies and community organizations that share our region. Public scrutiny leads to sharper audits, better partnerships, and—importantly—less staff turnover, because everyone in the plant knows their work matters beyond the factory gate.

    The Value of Technical Partnerships and Communication

    Every improvement and adaptation in our Etodolac Methyl Ester line comes from open communications with tech teams at partner companies. We lend direct support—sometimes dispatching our own process chemists to their sites, sometimes reviewing synthesis logs late at night, always in search of better outcomes for both sides. The back-and-forth with users leads to new purification tricks, improved filtration equipment, or simple storage tips that eliminate contamination risks. By investing in joint problem-solving, we’ve kept customers loyal not out of inertia, but because they know our doors are open when process glitches or spec drift threaten a product deadline.

    We regularly update our partners, not only with certificates or analytical reports, but with context notes: should a process window tighten, does an appearance shift hint at some slight batch perturbation? Open technical lines prevent confusion and delays, especially during plant upgrades or regulatory re-inspections. There is no substitute for a technical contact who actually understands how this ester behaves season to season, apparatus to apparatus.

    When process changes come—be it an equipment overhaul, a change in raw material source, or an enforced regulatory update—we let partners know ahead of time. Advance notice means recipes get validated before anything hits the production floor. This way, unexpected downtime or product recalls are less likely. Our habit is to err on the side of technical over-communication, because ambiguity costs more in the long run.

    Continuous Improvement as a Core Value

    Running a chemical manufacturing plant is an exercise in humility. Even with the best analytical equipment, deviations crop up—a missed solvent spec, a pump running off-speed, a sudden blip in impurity ratios. Each incident feeds our internal review cycles. The laboratory doubles as a learning center, where product improvement fights with cost controls and production speed. There are times when incremental tweaks yield major gains: an extra wash step, a narrower temperature band during synthesis, improved vacuum integrity during distillation. Data from each production run builds a repository—accessible not just to senior chemists, but to every technician who needs lessons learned translated into clear process instructions.

    No major change comes without a small army: QA and QC staff, plant operators, maintenance techs, process engineers, and logistics coordinators all raise flags and ask hard questions. Etodolac Methyl Ester, as a finished product, stands on the shoulders of all this practical intelligence. When a customer’s process fails, we analyze our own house before blaming upstream or downstream partners. A phone call to a chemist or operator usually surfaces root causes—without someone needing to write a report nobody will read.

    Staff turnover, equipment wear, supply chain shocks—these realities have shaped our production culture. Over time, humility gave way to pride in our ability to respond. An operator flags a batch as “off color”; a process engineer catches a divergence in HPLC trace. Immediate investigation follows, leading to stronger controls and sharper teams. Our partners benefit as much as our bottom line from this self-correcting ecosystem.

    View from the Ground: The Path Forward

    Delivering a high-quality Etodolac Methyl Ester means facing new challenges without falling back on hollow guarantees. Today’s regulatory expectations grow tighter, supply chain snags pull more attention, and customers expect both traceability and technical support on demand. We have learned that direct engagement, plain talk, and responsiveness matter more in the long run than glossy specs or abstract claims. If we miss a run rate, or face a yield drop, the solution lies in spending more time at the bench and on the plant floor, not in spinning the story.

    Our commitment isn’t transactional: we see the people who use our product every day, and we understand what delays, off-spec shipments, and process failures mean for them. By focusing on hard-won experience, technical partnership, and honest communication, we keep raising the standard for Etodolac Methyl Ester—not because regulators or clients demand it, but because our own integrity demands it. The real history of every batch leaves a trail from our process logs to the final formulation, and that’s a source of pride for every technician, operator, QA specialist, and process chemist in our plant.