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Butanilicaine

    • Product Name Butanilicaine
    • Alias Butanilcaine
    • Einecs 210-279-6
    • 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

    183904

    name Butanilicaine
    synonyms Butanylcaine, Hostacaine
    chemical_formula C16H24N2O2
    molecular_weight 276.375 g/mol
    CAS_number 137-32-6
    ATC_code N01BB05
    drug_class Local anesthetic
    route_of_administration Topical
    appearance White crystalline powder
    solubility Soluble in water and alcohol
    melting_point 102-104°C
    mechanism_of_action Blocks sodium channels, inhibiting nerve impulse conduction

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

    Packing & Storage
    Packing Butanilicaine, 25g: Supplied in a sealed, amber glass bottle with tamper-evident cap, labeled with hazard information and batch details.
    Shipping Butanilicaine is shipped in accordance with applicable chemical safety regulations. It is packaged in tightly sealed containers to prevent leakage, labeled with appropriate hazard symbols, and accompanied by safety data sheets. During transit, temperature and handling guidelines are strictly followed to ensure safe delivery and compliance with transportation laws.
    Storage Butanilicaine should be stored in a tightly closed container, kept in a cool, dry, and well-ventilated area, away from incompatible substances such as strong oxidizers. Protect the chemical from moisture and light. Store at room temperature or as specified by the manufacturer’s instructions. Ensure proper labeling and restrict access to qualified personnel to maintain safe and secure storage conditions.
    Application of Butanilicaine

    Applications of Butanilicaine in Industrial Manufacturing

    As a manufacturer specializing in chemical raw materials, we supply Butanilicaine with stringent control at every stage, focusing only on proven industrial applications. On this page, we highlight recognized downstream usage scenarios where our product supports high-value manufacturing processes, meets demanding compliance frameworks, and integrates precisely into established formulations. Each sector below outlines the specific role of Butanilicaine within regulated, process-driven industries.

    1. Local Anesthetic Formulations for Injectable Pharmaceutical Manufacturing

    Pharmaceutical producers incorporate our Butanilicaine primarily as an active anesthetic ingredient in the formulation of injectable local anesthetics, offering rapid onset and moderate duration of effect during minor surgical procedures and dental applications. Manufacturers depend on consistent raw material purity to guarantee compliance with global pharmacopoeias, while in-process quality assurance verifies pharmacological performance in every batch.

    Industry compliance standards

    • United States Pharmacopeia (USP) Monographs for Anesthetics
    • European Pharmacopoeia (Ph. Eur.) Specifications
    • Good Manufacturing Practice (GMP) under ICH Q7 & EudraLex Vol 4
    • Chinese Pharmacopoeia for Injectable Drug APIs

    Typical usage ratio

    • 0.5%–4% w/v in parenteral solutions, adjusted based on procedure type, patient profile, and regulatory maximum allowable dose.

    Downstream process integration

    • Active ingredient dissolved during the aqueous phase compounding step, followed by sterile filtration, aseptic filling, and terminal sterilization within GMP-certified cleanroom facilities.

    Final product types

    • Sterile local anesthetic injectable ampoules and vials
    • Dental anesthesia pre-filled cartridges
    • Preloaded syringes for minor outpatient procedures

    2. Topical Analgesic Creams and Gels

    Personal care, hospital, and OTC pharmaceutical manufacturers use Butanilicaine as a fast-acting analgesic in dermal cream, ointment, or gel bases for relief of localized pain and itching. Product development centers on achieving stable dispersion and skin absorption rates, respecting nation-specific over-the-counter regulations for local anesthetic concentration in non-injectable forms.

    Industry compliance standards

    • US FDA 21 CFR Section 348 (External Analgesic Drug Products for OTC Human Use)
    • EU Cosmetics Regulation (EC) No 1223/2009 (where applicable)
    • GMP for finished topical pharmaceuticals (ICH Q10 or equivalent)
    • TGA Australia 'Schedules of the Standard for the Uniform Scheduling of Medicines and Poisons' (SUSMP)

    Typical usage ratio

    • 0.1%–5% w/w, chosen according to product type (prescription/OTC), age group indication, and target pain severity, not exceeding local regulatory limits.

    Downstream process integration

    • Incorporation during the emulsification or homogenization stage, where Butanilicaine is mixed with other active agents, emollients, and stabilizers prior to filling into tubes or jars.

    Final product types

    • Topical anesthetic creams for minor burns, insect stings, or dermatitis
    • Gel formulations for muscle and joint topical pain relief
    • Pain-relief patches and occlusive wound dressings with analgesic layers

    3. Veterinary Local Anesthetic Products

    Veterinary pharmaceutical manufacturers select Butanilicaine for development of local and regional anesthetic preparations used in small and large animal surgeries, minor procedures, and wound care. Stringent controls require suppliers to provide consistent regulatory documentation for animal drug use, and process engineers must ensure proper dosage accuracy and animal safety across diverse veterinary products.

    Industry compliance standards

    • VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) Guidelines
    • European Medicines Agency (EMA) Veterinary Medicinal Products Regulation (EU) 2019/6
    • US FDA Center for Veterinary Medicine (CVM) Guidelines
    • Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF) – Veterinary APIs applicable standards

    Typical usage ratio

    • 0.25%–2% w/v in aqueous or lipid-based solutions, customized according to target animal species, weight range, and veterinary prescription protocols.

    Downstream process integration

    • Integrated as a veterinary active during aqueous blending, followed by sterilization filtration, bottle/vial filling, and online in-process titer verification by HPLC.

    Final product types

    • Injectable local anesthetic solutions for companion animals
    • Pre-dosed animal wound sprays and gels
    • Veterinary surgical anesthetic kits for field and clinical settings

    4. Pharmaceutical-Grade Research Chemical Supply

    Leading supply labs and pharmaceutical research centers depend on high-purity Butanilicaine as a reference material or analytical standard during development of generic formulations, new drug delivery systems, and pharmacokinetic studies. Stringent documentation, batch traceability, and full certificates of analysis are required to enable method validation, analytical development, and academic research.

    Industry compliance standards

    • ISO 17034 – General requirements for the competence of reference material producers
    • Good Laboratory Practice (GLP) Regulations (OECD, FDA, EMA)
    • Pharmacopoeia primary standards requirements (USP, EP, JP)
    • ISO/IEC 17025 – Testing and calibration laboratories

    Typical usage ratio

    • Supplied as pure standard or in specific concentration formats (1–1000 μg/mL), with the amount defined by the analytical method being validated or studied.

    Downstream process integration

    • Researchers dilute or reconstitute material in solvent systems during HPLC, GC-MS, or bioanalytical sample preparation procedures; used to calibrate instrument response factors and analytical accuracy.

    Final product types

    • Analytical reference solutions for lab qualification
    • Quality control calibrators for pharmaceutical manufacturing
    • Pharmacokinetic and bioequivalence study kits
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    Certification & Compliance
    More Introduction

    Butanilicaine: Practical Innovation from the Factory Floor

    A Direct Word from Our Production Team

    After years measuring, mixing, and refining local anesthetic compounds across dozens of product lines, butanilicaine stands apart in our workshop. Our facility shaped its current model, with every batch running through checked reactors, and methodic drying floors, before the white crystalline final product lands in our shipment drums.

    I’ve handled more than a few anesthetics across my career. Most have come with their own quirks—unreliable melting points, irregular particle sizes, or challenging solubility in the clinical mix. Our hands-on adjustments to synthesis routines, temperature controls, and purification steps made butanilicaine a smooth operator by comparison. Where others break down in the heat, clump during storage, or release impurities on handling, butanilicaine maintains a consistent melting point, a defined color profile, and a reliable response in solution.

    Outperforming with Reliable Specifications

    Every operator on our line learns that technical data sheets only tell part of the truth. Take melting point, for example. Standard butanilicaine leaves our finishing stage with temperatures ranging between 75–77°C—verified in our lab and cross-checked batch to batch. In practical terms, that stability means surgeons and pharmacists aren’t fighting precipitation during formulation or sudden loss of activity at room and body temperatures.

    We achieve a product purity regularly above 99%. You won’t find random off-white patches or suspicious streaks in our bags because we don’t just lean on some distributor’s word about source materials. We analyze feedstock, start with fresh solvents where possible, and demand thorough intermediate filtration—whether our customer calls for 25-kg drums or sacks by the ton.

    Versatile Application in Local Anesthetics

    Butanilicaine remains a workhorse in our anesthetic line. Hospitals, dental offices, and veterinarians find steady results at typical concentrations, whether deployed for infiltration anesthesia or nerve blocks. The compound lends itself to rapid dissolution into standard solvent systems, from sterile water to pharmacy-prepared gels, minimizing wait times and mixture inconsistencies.

    Over the years, we watched clients test our butanilicaine with other common local anesthetics like lidocaine or tetracaine. Practitioners often report similar onset of action, but our chemical’s duration outlasts basic competitors by a margin—short enough for routine procedures, yet long enough to avoid repeated dosing under the scalpel. In the rare cases measured, post-procedure reactions matched baseline anesthetics, without the overlay of toxic byproducts tied to less refined processes observed in off-market alternatives.

    Beyond Generic Production: Hands-on Quality Control

    There’s a marked difference between direct manufacturing and collecting from piles of bulk intermediates traded across continents. At our plant, every bag carries a batch code that actually means something: a date, a production line, and names of the lab staff who confirmed final assay and particle sizing. Quality assurance isn’t a paperwork routine. We walk the actual batches, check reactors on-site, watch for signs of residue buildup, and test samples from intermediate and final products at every stage.

    The reality of working with butanilicaine in our setting means no guesswork. Each team member has a clear protocol for sampling, documentation, and storage, which helps avoid temperature swings or contamination—a lesson hard-learned after earlier experiences with hygroscopic anesthetics. We maintain tight inventory rotation, never letting raw stocks rest in corners of the storage yard, and train everyone to recognize typical batch appearance. The benefit runs straight to the end-user, who never opens a package to find clumped material or a rancid odor indicating breakdown.

    Direct Advantage over Imported and Generic Products

    So many market samples come through our doors from generic sources—unmarked, lacking backstory, pushed by brokers cutting costs. What we keep hearing from technical evaluators is the puzzle of batch variability. Inconsistent melting range or off-odors frustrate formulation labs and clinicians. Trace analysis often turns up contaminants or residual solvents that never clear a reputable plant’s protocols. Our in-house butanilicaine, made from fully auditable raw inputs and finished under our supervision, doesn’t leave room for those doubts.

    We’ve fielded questions about alternative anesthetics claiming similar profiles. Yes, they can work in a pinch. Patients and end-users sometimes report increased sting at the injection site or unpredictable numbing times. Manufacturing experience suggests these troubles come from unstable compound structures or uncontrolled moisture absorption before packing. By focusing on rigid batch testing, we sidestep the headache of returns or customer complaints that plagued previous generic imports.

    Human-Centered Production: Worker Input and Daily Practice

    Jobs on our production floor bring you close to the material. That means hands run the machines and the solvent lines get cleaned by people who rely on their noses, their training, and their records. A technician unloading a fresh butanilicaine batch spots anything off-color straight away—there’s no trust in automation to do the full work. If anyone sees signs of caking or shifting particle size, a supervisor pauses the line and reruns filtration or drying, checking the impact right away in a side sample.

    You can’t build a high-performing local anesthetic without the feedback from those turning valves and washing glassware. Over time, we adjusted reaction times based on staff observation of seasonal humidity swings, dropped certain supplier relationships when quality slipped, and dialed in packing protocols to keep the end product fresh. In a climate with wide-ranging temperatures and pressures, lived experience on the floor turns directly into customer satisfaction.

    Why Reliable Butanilicaine Matters for Clinical Performance

    In active clinical settings, no nurse or doctor wants to second-guess a local anesthetic’s potency. We manufacture with that outcome fixed in mind. If a surgical team prepares an infiltration using our product, they get predictable response times, and the anesthetic holds up from ampoule to syringe without surprises. During batch trials, medical partners told us that switching to our material led to faster prep, smoother injections, and a drop in post-procedure queries about numbness or delayed recovery.

    Every lot passes standard microbial and heavy metal screening. Over the years, we’ve learned where cross-contamination typically creeps in, especially as other factories share lines between different drugs or solvents. That doesn’t happen under our roof. Clean-in-place systems, scheduled downtime for maintenance, and crew oversight keep unwanted agents from sneaking into the finished product.

    Reliability isn’t just marketing speak. Hospital records and feedback loops keep us accountable; we know which batches go to which regions and track lot performance in real-time. Any spike in failure rate or deviation triggers an immediate audit of our process. This dialogue helps us fine-tune everything from reactor pressures to final packing weight.

    Getting the Chemistry Right: Refinement and Scalability

    Our line doesn’t chase the lowest possible cost at the expense of batch stability. We learned the hard way that using quick-fix shortcuts—switching to cheaper reagents or skipping extra washes—results in frequent recalls and the risk of losing hard-won customers. Every season brings new trial runs to overhaul process times, reduce waste, and ensure that our butanilicaine scales evenly regardless of order size.

    Small-lot synthesis gets as much attention as bulk orders. Chemists run parallel trials, adjusting acid concentrations, solvent ratios, and thermal steps to lock down reproducibility. This investment in process control guards against the temptation to sacrifice quality to meet sudden surges—especially during crunch periods like regulatory audits or seasonal spikes in surgical demand.

    Differences from Other Anesthetics on the Line

    Experienced plant staff notice that butanilicaine handles more gently than complex structures like ropivacaine or bupivacaine. Those require careful management of base-acid separation or lengthy crystallization to avoid needle-shaped polymorphs. Butanilicaine forms neat, manageable crystals in reasonable time, sidestepping over-drying or the formation of hazardous dust. For shipping, this means fewer breakages, easier blending on the client side, and less loss to fines during transfer.

    Some of our competitors’ products give off telltale odors or develop off-white haze during long warehousing. We rarely see such degradation in our stock. The compound’s chemical backbone stands up to normal transport and storage, even in variable warehouse climates. This approach benefits both small buyers and institutional clients, who waste less on subpar or spoiled material.

    Meeting Regulatory and Practitioner Needs

    Regulatory agencies demand traceability, clean documentation, and clear labeling. We maintain full production records: certificates of analysis, batch test logs, and packing receipts. Inspectors walk our line and see every step, from weighing to blending, without gaps or guesswork. Meeting these standards year after year means practitioners get consistent outcomes and clinics avoid compliance trouble.

    Every lot undergoes thorough shelf-life verification in-house. We store retained samples and review them at set intervals, just as hospital pharmacies do, making sure time in storage doesn’t impact patient care. If a problem ever arises, clear records mean a fix happens quickly, without confusion or red tape.

    What the Future Holds for Butanilicaine Production

    Demand for high-quality local anesthetics like butanilicaine continues to climb, driven by patient expectations and expansion of minimally invasive procedures worldwide. Producers like us find ourselves balancing output against the drive for fully traceable and regulatory-compliant chemical supply. Quality doesn’t move forward by chance. Every new market and application brings a round of validation, internal review, and sometimes painstaking process adjustment.

    Feedback cycles are our lifeblood. We keep lines of communication open to clients and clinicians, drawing on both their praise and criticism to refine grind size, adjust drying conditions, or extend documented traceability. Compared to years past, our plant now sees fewer complaints, less waste, and more repeat customers—a testament to efforts rooted deep in on-the-job realities.

    Long-Term Commitment to Quality and Responsibility

    Workers in our facility understand the consequences of chemical shortcuts, not just in lost customers, but in lost trust. We treat each kilo of butanilicaine as medicine destined for critical patient care. That duty stays front and center, whether a young chemist is signing off on a daily assay sheet or a team leader is reviewing temperature logs at the end of a double shift.

    We make our practices visible, submit to outside audits, and take questions from clients and inspectors without hiding behind dense documentation or legalese. Consumers increasingly demand proof, not promises; our response is an open-door approach, proof of purity at every step, and the visible presence of working staff at every stage of manufacture.

    Placing quality at the core of daily routines means no one on the shop floor gets away with “good enough.” Issues spotted receive attention and correction, regardless of whether they delay shipments or slice into profit margins. Over time, those choices build greater reputation than any slogan or marketing campaign.

    Continued Progress—Built on Real Experience

    We don’t pretend every day is smooth, nor that every batch runs flawlessly. Still, the pride in shipping out a run of butanilicaine you know holds up in ERs, clinics, and dental practices across the country can’t be beaten. Each production run pulls on the entire team’s experience—every fix, correction, and tweak added to a bigger pattern of learning. Our progress as a manufacturer comes from shared lessons, hard data, and real-time problem-solving, not distant management guesses.

    As new requests come in from the global medical supply chain, and regulations shift, our continued investment in staff, process controls, and honest reporting keeps us nimble. We’re ready to serve the next generation of practitioners with butanilicaine that earns its place bottle by bottle, batch by batch, and patient by patient.