|
HS Code |
907693 |
| generic_name | Oxybucaine |
| other_names | oxybuprocaine |
| chemical_formula | C13H21N3O3 |
| drug_class | local anesthetic |
| route_of_administration | topical (eye, ear) |
| ATC_code | S01HA03 |
| CAS_number | 4741-53-1 |
| molecular_weight | 263.32 g/mol |
| mechanism_of_action | blocks sodium channels in nerve membranes |
| primary_use | surface anesthesia in ophthalmology and otology |
| appearance | white crystalline powder |
| solubility | soluble in water |
| prescription_status | prescription only |
| onset_of_action | rapid (within 1 minute) |
| duration_of_action | short (10–20 minutes) |
As an accredited Oxybucaine factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | The packaging for Oxybucaine features a white box labeled "Oxybucaine Hydrochloride, 20 mg," containing 10 glass ampoules. |
| Shipping | Oxybucaine is shipped as a regulated chemical, requiring secure packaging to prevent leakage and degradation. Transport must comply with local and international hazardous material regulations. The container should be clearly labeled, accompanied by a safety data sheet (SDS), and handled to avoid exposure to extreme temperatures or direct sunlight during transit. |
| Storage | Oxybucaine should be stored in a tightly closed container, protected from light and moisture, at a temperature below 30°C (86°F). It should be kept in a cool, dry place, away from incompatible substances and out of reach of children. Proper labeling and secure storage are important to prevent accidental misuse or exposure. |
Applications of Oxybucaine in Industrial ManufacturingOxybucaine serves as a critical active ingredient in several regulated industrial applications, primarily as a local anesthetic utilized mainly in pharmaceutical and medical device industries. The following content details core downstream uses based on Oxybucaine’s direct functional characteristics, relevant compliance systems, and practical integration into industrial production lines. 1. Sterile Topical Anesthetic Formulations for OphthalmologyOphthalmic solution manufacturers use Oxybucaine to formulate sterile topical anesthetic drops. It enables pain-free minor procedures, including tonometry, foreign body removal, and pre-surgical preparation. During formulation, strict monitoring of purity and microbial load is essential. Manufacturers use Oxybucaine due to its rapid onset and favorable ocular tolerance, requiring validated sterile processes and high-purity sourcing. Production must ensure reliable batch-to-batch consistency, as deviations may affect both patient safety and regulatory clearance. The finished products must comply with precise composition specifications for ophthalmic medical devices. Industry compliance standards
Typical usage ratio
Downstream process integration
Final product types
2. Surface Anesthetic Gels and Sprays for Endoscopic InstrumentsMedical device and pharmaceutical producers select Oxybucaine as the primary anesthetizing agent in lubricating gels and topical sprays for insertion of nasogastric tubes, endoscopes, and related medical tools. In this segment, the anesthetic is incorporated into water-miscible gel bases or ethanol-aqueous spray vehicles. Reliable supply enables manufacturers to pass product biocompatibility and extractables/leachables testing. Traceability to GMP batch records is standard practice. The chemical must meet low-staining, rapid-absorption criteria to align with clinical preparedness protocols. Lot-release testing ensures active content within strictly controlled tolerances as dictated by regulatory submissions. Industry compliance standards
Typical usage ratio
Downstream process integration
Final product types
3. Local Anesthetic-Infused Lozenges and Throat SpraysProducers of specialized pharmaceutical oral preparations use Oxybucaine for its rapid mucosal absorption and targeted numbing effect in lozenges and throat sprays indicated for pharyngitis, post-tonsillectomy pain, or stomatitis. Strict ingredient declaration and allergen tracing are required. Processing lines must prevent cross-contamination from other active agents and assure compliance with local maximum daily dosages. Granulation and wet-mixing steps require uniform distribution and accurate dosing. Quality teams routinely monitor stability and dissolution properties to satisfy registration and post-market surveillance audits. Industry compliance standards
Typical usage ratio
Downstream process integration
Final product types
4. Veterinary Anesthetic Formulations for Minor Animal SurgeryAnimal pharmaceutical manufacturers employ Oxybucaine in fast-acting local anesthetic solutions and gels targeted for companion animals during minor surgical interventions and diagnostic procedures. Formulation and filling must comply with veterinary-specific regulatory reviews and ensure operator safety during high-volume production. Trace contaminants such as heavy metals or residual solvents are tightly controlled. Products require validated dosing devices to avoid over-application. Documented supplier audits confirm feedstock provenance and consistency, enabling reliable registration with national veterinary medicine authorities. Industry compliance standards
Typical usage ratio
Downstream process integration
Final product types
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In the pharmaceutical manufacturing world, there is often a strong focus on antibiotics, steroids, or cutting-edge therapies, yet the value of local anesthetics can be overlooked until you’re in discomfort and needing fast, dependable relief. Oxybucaine stands among the specialized local anesthetics formulated specifically for topical and mucosal applications. We have worked with medical teams and researchers to create Oxybucaine that addresses the real needs experienced in clinics, dental offices, and surgical centers. Oxybucaine, a benzoic acid ester, helps medical professionals deliver localized numbness or pain control, targeting nerve endings precisely where intervention takes place.
Our Oxybucaine products come in several forms, but the key reference is Oxybucaine Hydrochloride, a water-soluble salt offering better handleability and formulation stability. The demand for Oxybucaine remains high due to its clinical effectiveness and patient tolerance, especially when compared to older anesthetics that sometimes produce unwanted stinging or systemic effects. It’s not just a matter of copying standard grades; the nuances in pH tuning, impurity thresholds, and micronization all matter if you expect reliable manufacturing runs and safe patient outcomes.
Years in chemical manufacturing have sharpened our appreciation for subtle details: moisture levels, particle size, and impurity content define more than shelf-life—they impact everything from dissolution rate to end-user experience. Our Oxybucaine Hydrochloride achieves high purity and meets the most current pharmacopoeia standards. Each batch undergoes moisture content measurement—accuracy here means fewer formulation problems later, especially for oral gels or rectal ointments. The controlled, fine particle size supports rapid dispersion in creams and liquids, crucial for healthcare professionals preparing custom dosage forms.
It’s a regular occurrence that regulatory inspectors focus on residual solvents and heavy metal content—so do our own technical teams. This routine scrutiny, layered with in-process monitoring, means the Oxybucaine reaching downstream pharmaceutical players is consistent and compliant. Each batch, whether destined for a compounding facility or a mass-market factory, tracks back through our records and fully documented laboratory assessments.
Different local anesthetics have different strengths. Some, like lidocaine, are versatile but bring a stronger risk of absorption into the bloodstream. Oxybucaine specializes in surface applications—oral, rectal, and bladder mucosa—where deep nerve penetration is not necessary, but gentle, targeted effect is. Across years of feedback from pharmacists and hospital staff, we’ve seen that Oxybucaine’s lower tendency to irritate is a core reason it holds its ground, even with competition from more well-known brands.
One key feature is how Oxybucaine reliably provides localized numbness without significant systemic toxicity. This is particularly useful for patients with restricted metabolism, children, or individuals requiring repeated doses over several days. Our manufacturing avoids the bitterness and allergen load seen with some legacy anesthetics by using advanced purification and controlled reaction pathways. In our experience, this guarantees both safety and comfort for end users.
We’ve been through shifts in regulatory expectations, supply chain disruptions, and even sudden spikes in raw material prices. Through all of this, one thing remains clear: consistency in process translates directly to consistent product. Our team doesn’t just rely on automated lines; skilled technicians analyze raw material lots, adjust for seasonal humidity differences, and calibrate reactor conditions by more than just automation. The Oxybucaine that leaves our facility matches tight impurity profiles and stability targets. If a deviation does occur, batches are held back and reanalyzed before release, as the last thing anyone wants is a callback or clinical complaint.
The movement of pharmaceutical raw materials faces regulatory and temperature hurdles every day. To ensure integrity, we pack Oxybucaine in light-protective, airtight containers, based on real-world stability data from long-term retention studies. Our logistics staff tracks every shipment to avoid unnecessary exposure to temperature extremes, which can trigger unwanted hydrolysis or discoloration. Finished goods only leave when our in-house laboratory confirms full compliance with assay, pH, endotoxin, and particulate matter requirements.
Most Oxybucaine users encounter the compound in oral gels, lozenges, rectal suppositories, and topical wound creams. The real challenge for finished drug manufacturers often comes from making products that go on tender or inflamed tissue—no one wants unnecessary burning or sensitivity. We pay close attention to the byproducts and stabilizers in our process to lessen the risk of any secondary irritation.
Technical partners often consult with us before major production runs because pH drift or solubility problems can ruin batches. Over time, minor tweaks—slightly tighter granulation limits, improved washing—have made our Oxybucaine less finicky to formulate with. Our feedback loop with industry partners means new dosage forms like transmucosal films or rapidly dissolving tablets can be developed using Oxybucaine as the active anesthetic base.
Market demand for compounded medications grows every year, especially as hospitals retrofit anesthetic stockpiles to handle shortages. We continue to support compounding pharmacies by providing thoroughly documented material, free from filler impurities and cross-contamination frequently seen in bulk-sourced alternatives. We share best practices learned from production to support accuracy, from scalable wet mixing to final sterilization.
Patient feedback is never far from our minds, even though we manufacture the starting material. Medical professionals turn to us with outcome data, asking us to trace back complaints about aftertaste, irritation, or inconsistent onset. We respond with transparent process adjustments and product upgrades, always maintaining traceable records. Hospitals appreciate these open conversations, since the connection from API plant to patient is often shrouded in anonymity in the pharmaceutical sector.
Since Oxybucaine rarely provokes allergic reactions and resists absorption through inflamed membranes, it remains a dependable option in sensitive cases—geriatric care, pediatric medicine, and palliative situations. Healthcare workers rely on this consistency, not just for their patients’ comfort, but for the predictability that helps avoid dosing mishaps or regulatory problems after the fact. Our standards come from real-world needs, not just chemical formulas.
Every hospital formulary considers price, patient comfort, and regulatory status when choosing an anesthetic ingredient. Oxybucaine sits in a unique position: on one hand, more surface-focused than lidocaine or tetracaine, and on the other, gentler in taste and sensation than benzocaine. Other manufacturers may produce similar molecules, but the key difference comes from handling and downstream performance.
Oxybucaine stands out by offering less bitterness, cleaner taste, and fewer secondary reactive residues in oral-based or mucosal dosage forms, compared to some older options. Pharmacy managers and prescribers benefit from this feature, particularly in pediatric applications where patient resistance or accidental swallowing is a concern. Unlike some legacy anesthetics prone to rapid breakdown, Oxybucaine's shelf-life—supported by our ongoing stability testing—meets modern distribution challenges with confidence.
Another distinction comes in solubility. Many anesthetics, particularly benzocaine, show poor water solubility and require extensive emulsification for use in gels or rinses. Oxybucaine Hydrochloride, as we produce it, dissolves easily, which cuts down processing time and sidesteps the need for aggressive solvents. This supports both small-scale compounding and industrial-scale automated filling without unexpected clumping or sediment.
Pharmaceutical ingredients draw increasing scrutiny for their environmental footprint. Over years of operation, we have refined Oxybucaine manufacturing with cleaner processes, closed-loop solvent recovery, and waste minimization. Effluent is monitored for organic load and pH in real-time, rather than just spot-checked at the end. Each improvement reduces the downstream burden on local water treatment and lessens overall resource use per kilogram of Oxybucaine delivered.
We also source starting materials from vetted suppliers who comply with environmental norms and offer transparency down to the transportation leg. Our byproducts undergo further treatment or energy recovery, minimizing disposal impact. Stakeholder feedback, from local health authorities and environmental agencies, shapes each improvement. For customers, these efforts mean a more responsible supply chain, which grows more important as procurement officers and regulators increase their expectations for traceability and sustainability.
Process improvement doesn’t stop once a batch passes final analysis. Our technical teams collect and analyze in-process deviations, even if products leave the door within spec. Small issues, from particle size drift in winter to unexpected color change during long shipments, prompt manufacturing reviews and sometimes complete revamps of best practices. We communicate these updates to our partners so they understand how process innovation works its way into each Oxybucaine order.
Feedback flows both ways. Finished pharmaceutical manufacturers often share their own challenges: compatibility problems with novel excipients, requests for tighter endpoints, or demands for new analytical methods. In these cases, we cooperate, opening our plant to site audits or adapting our production to fit unusual downstream needs. This level of exchange lowers risk for all parties; nobody wants a recall or regulatory hold because of a missed detail in the early stages.
Global oversight defines every aspect of pharmaceutical ingredients. We audit our records, track every handoff, and maintain robust change control documentation. Oxybucaine moves with full batch traceability, from source and processing log to shipment and end-user confirmation. Regulators can request any part of the chain, and we respond quickly, supporting both customer compliance and our own transparency goals.
We also keep careful watch on evolving pharmacopeia standards. As monographs update to tighten allowable impurity levels or require more sensitive analytical techniques, our laboratory teams anticipate these changes and adjust processes or test methods before deadlines arrive. This keeps Oxybucaine accessible to customers in North America, Europe, and Asia, reducing costly interruptions or regulatory reviews.
New medical devices and dosage forms demand ongoing partnership with ingredient manufacturers. As transmucosal films, well-tolerated lozenges, and easy-to-apply gels develop at record speed, formulators need Oxybucaine that behaves as expected under new process conditions. Our R&D staff participates in studies to predict compatibility not just with classic excipients, but with biopolymers, plasticizers, and other emerging formulation aids.
We support pilot-plant and scale-up operations, sharing our analytical results and formulation recommendations. With feedback loops back to our plant floor, we sometimes adapt production—whether by changing micronization techniques or reducing unwanted byproducts—to better serve the final patient. These direct lines between science, engineering, and customer feedback give Oxybucaine its unique position in the market and ensure our focus remains on tangible, real-world outcomes.
Oxybucaine, like all pharmaceutical building blocks, carries responsibility. We prioritize clarity in every document we release, from safety data to shipping manifests. Customers receive full transparency about material origin, storage advice, and shipping timelines, so they can plan for both routine use and emergencies. Mishaps don’t get swept aside; we log, investigate, and inform partners whenever something unexpected occurs, aiming for trust rather than just compliance.
Training isn’t an afterthought. Our staff undergoes regular education on handling hazardous materials, GMP changes, and customer privacy rules. Technical support is readily available, assisting with material investigations or fielding questions from regulatory agencies. Each batch of Oxybucaine, before it ships, reflects hundreds of small checks both human and automated—proof of our commitment to both product and people.
Many years in chemical manufacturing have shown us the impact an ingredient can have at the bedrock level of patient care. Oxybucaine, as we produce it, represents more than a chemical—each shipment supports safe, comfortable, and consistent pain relief for clinics and hospitals. We’ve responded to challenges from supply chain to sustainability, always focused on the people whose everyday relief depends on our work. Every discussion with our partners, every tweak to quality control, and every change in the plant serves the singular goal of reliable patient outcomes. In a world filled with changing health needs and rising regulatory demands, our Oxybucaine stands for accountability, safety, and practical know-how.