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Benzocaine Hydrochloride

    • Product Name Benzocaine Hydrochloride
    • Alias Ethyl p-aminobenzoate
    • Einecs 223-095-2
    • 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

    200891

    Chemical Name Benzocaine Hydrochloride
    Molecular Formula C9H12ClNO2
    Molar Mass 201.65 g/mol
    Appearance White crystalline powder
    Solubility In Water Freely soluble
    Melting Point 215-217°C
    Pka 2.5 (as hydrochloride salt)
    Usage Topical local anesthetic
    Storage Conditions Store at room temperature, protected from moisture
    Cas Number 23239-88-5
    Stability Stable under recommended storage conditions
    Odor Odorless
    Synonyms Ethyl p-aminobenzoate hydrochloride

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

    Packing & Storage
    Packing The packaging for Benzocaine Hydrochloride is a sealed, labeled 500g amber HDPE bottle, featuring hazard symbols and batch identification.
    Shipping Benzocaine Hydrochloride is shipped in tightly sealed, clearly labeled containers to prevent contamination and moisture exposure. It is transported as a chemical substance according to local and international regulations, typically as a non-hazardous material, and stored in a cool, dry place away from direct sunlight and incompatible substances.
    Storage Benzocaine Hydrochloride should be stored in a tightly closed container, protected from moisture and light. Store at room temperature, typically between 15°C and 30°C (59°F–86°F). Keep away from incompatible substances, such as strong oxidizing agents. Ensure the storage area is well-ventilated and dry to maintain stability and prevent degradation or contamination of the chemical.
    Application of Benzocaine Hydrochloride

    Applications of Benzocaine Hydrochloride in Industrial Manufacturing

    As a direct manufacturer specializing in benzocaine hydrochloride, our focus is on enabling downstream industries with high-purity, consistently processed raw materials that meet demanding regulatory and functional requirements. The following sections detail critical B2B application scenarios where our production quality and technical support align with real manufacturing processes and compliance obligations.

    1. Topical Anesthetic Formulations in Pharmaceutical Manufacturing

    Pharmaceutical contract manufacturers and finished dose producers use benzocaine hydrochloride as the local anesthetic component in non-injectable topical products. Its rapid onset and tolerable safety profile make it a preferred active ingredient for formulations designed for acute pain management on mucous membranes and skin. Facilities integrate this API at precise dosing during semi-solid or liquid batch compounding, enabling standardized texture and measured activity in gels, creams, sprays, and ointments for pediatric and adult indications. Rigid compliance checks involve raw material traceability, wet chemistry identification, and pharmacopoeial conformity.

    Industry compliance standards

    • USP, EP, JP pharmacopeias for APIs
    • FDA 21 CFR 330 Subpart D for OTC anesthetics
    • Current Good Manufacturing Practice (cGMP, ICH Q7)
    • Certificate of Suitability (CEP) if required for EU

    Typical usage ratio

    • 5–20% w/w in creams and ointments depending on topical product class and local max dose limitations
    • Adjustment for viscosity, spreadability, and local regulatory dose limits

    Downstream process integration

    • Dispensing and pre-blend during aqueous or oil phase preparation
    • Dissolution under controlled temperature and agitation
    • Homogenization before final filling and packaging
    • In-process testing for assay and identity prior to release

    Final product types

    • Topical creams and ointments (e.g., pain relief, burn care)
    • Sore throat and oral ulcer gels
    • Ear drop solutions for otic analgesia
    • Mucosal sprays (oral, pharyngeal)

    2. Medical Device Surface Numbing Agents

    Manufacturers of medical devices—such as catheters, endoscopic equipment, and diagnostic swabs—use benzocaine hydrochloride to provide transient local surface anesthesia. The compound is incorporated into films, coatings, or hydrogels which are subsequently laminated, sprayed, or bonded to device components. This integration aims to reduce patient discomfort during placement or minor procedures and meets stringent biocompatibility and sterilization validation requirements in the finished medical product.

    Industry compliance standards

    • ISO 10993-1 (Biological Evaluation of Medical Devices)
    • USP Class VI biological testing
    • 21 CFR Part 820 (Quality System Regulation for Devices)
    • EU MDR (Medical Device Regulation) if marketed in Europe

    Typical usage ratio

    • 1–10% w/w in gel coatings and impregnated pads or strips
    • Percentage based on intended release profile and device surface area

    Downstream process integration

    • Incorporation into polymer or hydrogel mixes during coating preparation
    • Spray, dip, or laminate application onto device surface
    • Curing and sterilization as per device’s aseptic process
    • QC release includes extractables/leachables testing for residual anesthetic

    Final product types

    • Anesthetic-lubricated catheters
    • Numbing medical swabs and applicators
    • Anesthetic-coated endoscope tubes
    • Pain-reducing wound dressing films

    3. Dental Preparations for Professional and OTC Use

    Within dental manufacturing, benzocaine hydrochloride is a core ingredient for temporary relief formulations, including pre-procedural gels used before injection or minor dental procedures. Dental material manufacturers integrate this compound during batch compounding, ensuring uniform dispersion for controlled taste and spread on oral mucosa. The formulation must comply with specific dental material standards and face rigorous analytical and toxicological controls before release to both clinical and consumer channels.

    Industry compliance standards

    • ANSI/ADA No. 41 for topical anesthetic agents
    • USP monograph for benzocaine-based dental gels
    • FDA OTC Monograph M16 (Dental drug products)
    • ISO 13485 (Medical Device QMS, for products classified as medical devices)

    Typical usage ratio

    • 10–20% w/w in gels intended for gingival application
    • Varied within regulatory maximums for pediatric and adult use

    Downstream process integration

    • Direct weighing and dispersion into gel base during batch preparation
    • pH adjustment for mucosal compatibility
    • Filling into sterile, single-use applicator tubes or jars
    • Microbial and residual solvent testing before distribution

    Final product types

    • Dental numbing gels (professional and OTC)
    • Pre-injection oral topical agents
    • Teething pain relief gels
    • Gingival sprays for chairside use

    4. Veterinary Topical and Mucosal Formulations

    Veterinary pharmaceutical manufacturers utilize benzocaine hydrochloride in topical pain relief compositions, especially for small animal clinical use and livestock minor procedures. The bulk raw material is introduced at significant activity levels into oil- or water-based solutions and ointments customized for species-specific dosing. Regulatory compliance considers both animal-specific pharmacopoeias and food safety in food-producing animals, with cross-verification in QC on residue and withdrawal periods where required.

    Industry compliance standards

    • FDA Center for Veterinary Medicine guidelines
    • VICH GL9 (GCP for Veterinary Studies)
    • USP monographs (where applicable for veterinary use)
    • National Food Safety and Residue Control standards for food animals

    Typical usage ratio

    • 5–15% w/w in veterinary topical sprays and ointments
    • Adjusted based on animal size, application method, and product withdrawal period

    Downstream process integration

    • Dissolution into formulation base during batch tank compounding
    • Homogenization for particle size control
    • Dispensing into dosing syringes, bottles, or topical applicator units
    • Batch release includes stability, residue, and safety testing

    Final product types

    • Veterinary wound sprays
    • Pre-surgical topical anesthetic ointments
    • Mucosal pain relief gels for animals
    • Poultry beak and livestock castration anesthetic applications

    5. Specialty Rapid-Action Analgesic Lozenges and Troches

    In the production of medicated lozenges and troches for rapid oral mucosal pain relief, manufacturers incorporate benzocaine hydrochloride for its fast onset and tailored release. Bulk active material dispersion occurs during the hot-melt or wet-dry mixing stages, with precise analytical controls to ensure uniform content and dissolution within regulated potency ranges. Compliance with both food-grade and drug-grade manufacturing standards applies, dependent on local market classification of the lozenge type as medicinal or nutraceutical.

    Industry compliance standards

    • USP monograph for dosage forms (lozenges, troches)
    • FDA 21 CFR 330.1 General Monograph for OTC Oral Anesthetics
    • FSMA (for food-grade production lines)
    • cGMP for finished dosage forms

    Typical usage ratio

    • 2–10 mg per lozenge, corresponding to 0.5–1% of finished product mass
    • Dose adjusted to local regulatory caps for pediatric or adult products

    Downstream process integration

    • Hot-melt blending during lozenge base preparation
    • Uniform dispersion achieved via planetary mixing
    • Molding and cooling followed by high-precision automated counting and packaging
    • In-process control for weight, uniformity, and dissolution testing

    Final product types

    • Oral anesthetic lozenges (rapid pain relief)
    • Medicated troches for mouth sores
    • Combined cough and pain relief candies (supplemental ingredient)
    • Single-use analgesic tabs for oral surgery aftercare
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    Certification & Compliance
    More Introduction

    Benzocaine Hydrochloride: Inside the Production Line

    What Sets Benzocaine Hydrochloride Apart

    Every day on the factory floor, we shape Benzocaine Hydrochloride from the earliest stages of reaction to the last step of quality control. The difference between Benzocaine base and its hydrochloride counterpart marks a turning point in pharmaceutical chemistry. Benzocaine Hydrochloride emerges as a water-soluble salt, born from the combination of Benzocaine and hydrochloric acid. Many customers come to us seeking an anesthetic that not only delivers local numbing but can also dissolve easily in water-based formulas. That’s where this salt comes into play. Raw Benzocaine powder often lacks full compatibility with water, limiting its range in modern formulations. Benzocaine Hydrochloride, by contrast, slips seamlessly into creams, gels, and injectable solutions. No need for extra solvents or complicated processing.

    In our plant, the transformation hinges on precision. The hydrochloride salt formation doesn’t tolerate shortcuts or casual measurement. Ph-adjustment is critical. Too much acid and the product risks over-acidification; too little and the conversion stays incomplete, ultimately leading to losses and regulatory headaches. Chemistry is unforgiving about sloppiness. Operators monitor temperature and agitation, always alert to the tell-tale snow-white crystal bloom signifying a clean reaction. We filter and dry the crystalline powder, pushing every batch through sieve analyses and moisture screens to confirm tight particle-size control. No two production runs are identical, and only veteran technicians can predict the small changes that ambient humidity or raw material lots might cause.

    You won’t find Benzocaine Hydrochloride sold by us in bulk sacks at the back of an e-commerce site. Our product serves the pharmaceutical industry primarily, where the stakes are high and standards leave no room for improvisation. Model numbers reflect our process controls, with material typically graded on purity — above 99% for heavy-duty medical use, slightly lower for industrial cleaning or research labs where final purity gets corrected downstream. We document each batch with chromatographic readings, water content, and heavy metal screenings. Having managed these controls for years, we know how quickly reputations crumble on a single substandard lot.

    Purity and Process: Real-World Implications

    Some industry clients arrive with strict specifications for Benzocaine Hydrochloride. They explain exactly what their topical anesthetic needs — rapid numbing for a mouth ulcer, a gentle touch for an infant’s earache, or a stable solution for lab diagnostics. We work closely with formulators to tweak drying cycles, optimize granulation, and avoid cross-contamination from other active pharmaceutical ingredients. Quality department staffers double-check for residual solvents and non-target ions, since these can ruin even the best-compounded cream by affecting cutaneous absorption or taste. Our teams have stood through late-night audits from clients whose own supply chains collapsed after careless sourcing from low-tier producers. Consistent purity levels save them the expense and anxiety of recalls.

    Much of this nuance escapes fast-moving traders. A simple internet search pulls up dozens of "Benzocaine Hydrochloride" offers, but only a few names trace back to direct producers. Many resellers list product simply by model or mesh size, but little background data to help buyers trace origin or validate longevity in storage. As a manufacturer, we track shelf life right back to the drying oven. Precipitate storage temperature shifts by even a few degrees, humidity gets inside a poorly sealed container, and months of product stability evaporate. Packing for Benzocaine Hydrochloride leans toward double-sealed, light-resistant barrels. Each one labeled with production run, lot number, date of manufacture, and code stamped before it leaves the clean room. There’s a community of customers across continents who know the value of tracking direct from our plant, rather than a faceless warehouse.

    Applications: How Benzocaine Hydrochloride Enters Daily Life

    In daily production, we see where this molecule fits wider markets. Benzocaine Hydrochloride lands in topical gels for dental clinics, sprays for sore throats, creams handling skin irritation, and veterinary products soothing animal procedures. Pharmacies rely on it for numbing gels that patients trust during minor oral interventions or piercings. Its hydrochloride form solves a problem for makers of mouthwashes and wound rinses, letting them avoid oil-based suspensions that could cloud solutions or leave sticky residues behind. Those small choices give end products a cleaner taste, quicker action, and greater acceptance among consumers.

    Staff chemists field technical questions from multinational cosmetics companies and small-town hospital suppliers alike. Can they get a form that leaves minimal residue on skin? Will a certain grade irritate delicate tissue, or does it pass hypoallergenic standards? Each time the need arises, we run lab trials, compare analytical benchmarks, and produce tailored reports laying out test conditions and findings. The difference between a smooth, water-clear Benzocaine Hydrochloride and a hazy, inconsistent one can mean the difference between market success and failure.

    We’ve watched as regulatory agencies worldwide continue to ramp up scrutiny on local anesthetics. Strict thresholds for nitrosamine contaminants and heavy metals compel rigorous validation at every turn. It keeps our laboratory working overtime on documentation, batch revaluation, and in-depth analysis well before any package ships. These processes impact more than just a spec sheet; they define company reputation and patient well-being. A recall for failed purity damages confidence across the industry, and years of dedicated production habits cannot undo that kind of blow.

    Operational Challenges and Solutions

    Staying ahead in Benzocaine Hydrochloride production requires discipline. Temperature spikes during synthesis or drying reduce purity, slow workflow, or produce unwanted degradation byproducts. Operators check seals on hydrogen chloride tanks before every run. Savvy plant managers invest in temperature-logged rooms instead of traditional dry storage, cutting spoilage and unexpected lot failures. We handle acid dosing by weight and not by volume to avoid errors that less experienced shops might overlook. Experience develops as much from troubleshooting mishaps as from textbook process flows.

    Sometimes clients request Benzocaine Hydrochloride blends they see online, but many of those are speculative or based on incomplete science. Few laboratory concoctions transfer smoothly to full-scale production. Scale-up isn’t simply pouring larger volumes but handling new pressures, agitation speeds, and heat loads. As a direct manufacturer, we run pilot batches in the same vessels used for commercial runs, isolating problems before a major lot launch. We record outcomes, tweak parameters, and learn incrementally. Outsiders rarely see these details; they just witness the dependable product results.

    Adaptation runs deep in our line of work. Shifting regional rules on allowable impurity levels keep our quality control technicians in close touch with legal teams and regulatory authorities. We meet those standards whether our product lands in a small city hospital or a major export market. By staying ahead of regulations, we avoid dangerous late-stage product withdrawals that plague less diligent producers. Drawing on years of experience, we can spot trends and react quickly to new cheat codes or product adulteration threats circulating on the gray market.

    Comparisons With Other Local Anesthetics

    Compared to other local anesthetics such as Lidocaine Hydrochloride, Benzocaine Hydrochloride finds its place through distinct physical and chemical properties. While Lidocaine Hydrochloride offers a rapid onset and deep tissue penetration suited to injections and high-intensity dental work, Benzocaine Hydrochloride matches best with topical applications where prolonged, mild numbing is preferred. Our customers choose it for procedures where systemic absorption must remain minimal. R&D staff in our plant have worked on repurposing Benzocaine Hydrochloride for new delivery systems, including mucoadhesive strips and slow-release patches. The salt form’s solubility makes those innovations far more achievable.

    There’s a tendency among some buyers to chase after whatever is trending in research circles without fully considering their end-use requirements. In practice, our technical team guides developers through cost-benefit analyses, showing how Benzocaine Hydrochloride offers reliable results when rapid-onset injection isn’t necessary. For skin or mucosa-facing applications, it carries a safety profile developed over decades of use, so long as dosing stays within recognized medical norms. This experience bridges the gap between abstract chemical characteristics and real customer needs. Both product stability and user feedback shape future iterations in-house. Laboratory teams keep their eyes on market feedback, safety reports, and professional journal updates, refining process steps accordingly.

    Traceability and Customer Assurance

    Each outgoing drum of Benzocaine Hydrochloride features a trail of paperwork, electronic records, and certificate data going back to raw input sourcing. We accommodate regular on-site audits from accredited third parties and, in some cases, customer representatives who conduct their own checks. Trusted partnerships can only form when both sides maintain confidence in traceability. Sometimes, customers arrive with problems inherited from lower-quality products — mystery discolorations, unexpected odor, or visible clumping — and our laboratory runs parallel comparisons, seeking root causes and remediation steps. Our history in resolving these challenges builds respect among professional buyers.

    On occasion, a batch tests just slightly outside a pharmaceutical customer’s more restrictive limits. Instead of hiding the result or making excuses, production and sales staffers contact clients immediately, offering detailed analyses, retest data, and, where possible, guidance for reformulation or safe reprocessing. This transparency keeps partnerships running smoothly year after year. Worse yet are competitors who pass off lower-purity Benzocaine base as hydrochloride. Our facility implements infrared and chromatographic checks on every incoming and outgoing shipment to counteract such practices. Documentation means more than paperwork — each number sharpens the trust between us and our partners.

    Lessons Learned: Improvements in Benzocaine Hydrochloride Production

    Continuous improvement runs through our facility culture. Several years ago, recurring customer requests prompted us to introduce a finer mesh grade suitable for newer transdermal patches. Standard batches, typically tailored to older gel and cream systems, left too many large particles for even spreading in newer technology. After weeks of trialing milling steps and adjusting filter systems, we dialed in optimal agitation and sifting techniques. We rolled out the improved grade, followed up with customer field testing, and adjusted again when the feedback pointed to lingering micro-aggregation under humid conditions. Learning doesn’t stop with a sales contract. It continues as refinements based on what researchers, compounding pharmacists, and front-line healthcare professionals experience in real-world conditions.

    Investments in better in-house water purification, inspired by early trouble with residual conductivity, have paid off. Any impurity in process water ends up inside the Benzocaine Hydrochloride crystal, and those minuscule ions start to matter at scale. High-purity water, checked daily for conductivity, brings downstream clarity and greater shelf stability to the finished product. Years of underappreciated lab work finally show up in reliably clean, sparkling batches that withstand hot and cold shipping cycles, air-freight, and months in clinical storage.

    Commitment to Real-World Outcomes

    Benzocaine Hydrochloride flows out of our reactors not as an abstract chemical name but as a solution to concrete industry problems. Our teams interact with scientists from multiple fields: drug development, wound management, veterinary care, and public health. They bring us case studies on end use, detail pain points, and propose alternative dosage forms. We listen, run small-scale stability tests, and translate those insights into batch modifications, new packaging steps, or technical bulletins detailing use-case scenarios. Each improvement moves the needle in helping professionals meet tough regulatory and patient standards.

    Someone outside the industry looking at a bottle of medicated gel in a pharmacy might overlook what goes into creating stable, clinically useful Benzocaine Hydrochloride. As direct manufacturers, the product is more than just a name on a label or an item in inventory. It reflects hundreds of combined years of process know-how, repeated investments in plant modernization, and active engagement with changing global standards. Those factors create consistent, high-performing material batch after batch, year after year.

    Responsibility and Forward-Looking Manufacturing

    We see responsible chemical manufacturing as an ongoing conversation with customers, regulators, and the end users whose products depend on Benzocaine Hydrochloride. Each advancement in process control, worker training, and plant stability responds to lessons our teams have learned from close calls and customer input. Sometimes, that means a new instrument in the quality assurance lab; other times, clearer labeling or a revised drying protocol. Foresight and adaptation put us in a position to help clients sidestep problematic supply chain disruptions or product recalls.

    Demand for high-quality Benzocaine Hydrochloride will continue. Direct manufacturers bear the responsibility of honest sourcing, clear communication, and technical expertise. From start to finish, knowledge gained in the factory shapes material that safely and effectively meets the needs of those who put it to practical use. Real chemical production challenges don’t resolve with slogans or generic guarantees but with continual attention to accuracy, transparency, and learning at every step. Each batch becomes a reflection of that commitment.