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Oxymetazoline

    • Product Name Oxymetazoline
    • Alias Afrin
    • Einecs 220-120-9
    • 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

    481668

    Generic Name Oxymetazoline
    Drug Class Decongestant
    Common Brand Names Afrin, Dristan, Zicam
    Dosage Form Nasal spray
    Route Of Administration Intranasal
    Mechanism Of Action Alpha-adrenergic agonist causing vasoconstriction
    Primary Use Relief of nasal congestion
    Onset Of Action Within minutes
    Duration Of Action Up to 12 hours
    Prescription Status Over-the-counter
    Side Effects Nasal dryness, irritation, rebound congestion
    Contraindications Hypersensitivity, narrow-angle glaucoma
    Pregnancy Category Use with caution

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

    Packing & Storage
    Packing The packaging for Oxymetazoline features a 15 mL amber plastic dropper bottle, labeled with dosage instructions and safety information.
    Shipping Oxymetazoline should be shipped in a tightly sealed container, protected from light, moisture, and extreme temperatures. Ship in accordance with local, national, and international regulations, typically as a non-hazardous chemical. Utilize appropriate outer packaging to prevent leaks or spills, and ensure proper labeling and documentation for safe transport.
    Storage Oxymetazoline should be stored at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). Keep the container tightly closed, away from moisture, heat, and direct light. Store in a dry place and out of reach of children. Do not freeze. Ensure the storage area is well-ventilated and avoid contamination with incompatible substances.
    Application of Oxymetazoline

    Applications of Oxymetazoline in Industrial Manufacturing

    Our direct manufacturing expertise supports the integration of oxymetazoline into a spectrum of specialized downstream industries. Each sector follows distinct compliance protocols, process requirements, and technical formulations. The following sections outline verified industrial use cases, with an emphasis on regulatory demands, proven dosage guidelines, production steps, and the resultant finished goods across real-world application tracks.

    1. Nasal Spray Pharmaceutical Production

    Pharmaceutical manufacturers incorporate oxymetazoline in intranasal decongestant sprays for both adult and pediatric markets. Production lines must adhere to stringent national pharmacopeia standards to ensure ingredient identity, purity, and correct dosage forms. Formulation typically blends the active with sterile aqueous solvents, stabilizers, and appropriate pH adjusters to achieve consistent atomization and shelf stability.

    Industry compliance standards

    • United States Pharmacopeia (USP) Monograph for Oxymetazoline Hydrochloride
    • European Pharmacopoeia (Ph. Eur.) requirements for intranasal preparations
    • FDA 21 CFR Part 211 (Current Good Manufacturing Practices for Finished Pharmaceuticals)
    • GMP guidelines as per WHO TRS 986, Annex 2

    Typical usage ratio

    • 0.025% to 0.05% w/v final concentration, titrated based on age group and formulation stability data
    • Pediatric sprays favor lower range, adults at upper limit as per labeling and clinical constraints

    Downstream process integration

    • Direct addition in solution preparation tanks after water-for-injection (WFI) step
    • Homogenization, pH adjustment, and sterile filtration prior to filling
    • Batch QC measures: identity, assay, microbial limits, spray characteristics

    Final product types

    • Metered-dose nasal sprays (glass or polymer bottle packaging)
    • Pump mist nasal inhalers
    • Unit-dose intranasal applicators for clinical use

    2. Topical Decongestant Gel Manufacturing

    Oxymetazoline supports formulators in producing non-prescription topical gels used for local vasoconstriction in the nasal, dermal, and mucosal areas. Integration occurs under regulatory oversight for both active and excipient safety, with emphasis on dermal absorption and local tissue compatibility during gel compounding in non-sterile, controlled environments.

    Industry compliance standards

    • US FDA 21 CFR 330.41 (OTC External Nasal Products Monograph)
    • Health Canada NNHPD Natural Health Product regulations—decongestant topical category
    • ISO 22716:2007 (Cosmetics—Good Manufacturing Practices)
    • EU Regulation (EC) No 1223/2009—Cosmetic Products

    Typical usage ratio

    • 0.025%–0.05% by weight in gel matrix, with range chosen by local pharmacovigilance requirements and patch test results

    Downstream process integration

    • Active ingredient dissolved with humectants and thickening polymers in temperature-monitored reactors
    • Sequential addition of preservatives, chelators, and pH buffering agents
    • Routine viscosity, microbiological, and residual solvent testing before tube filling

    Final product types

    • Non-prescription nasal or dermal decongestant gels (aluminum or laminated tubes)
    • Localized mucosal vasoconstrictor gels for hospital supply
    • Travel-size single-use sachets for over-the-counter retail

    3. Ophthalmic Solution Compounding for Eye Drops

    Manufacturers use oxymetazoline in eye drop formulations intended for temporary redness relief. Design and output require precision in dosing, particulate control, and isotonic balancing, in accordance with ophthalmic regulations. Solutions must maintain optical clarity and microbiological purity, necessitating controlled environments and closed-system manufacturing.

    Industry compliance standards

    • USP <771> Ophthalmic Preparations
    • Ph. Eur. Monograph for Ophthalmic preparations
    • FDA 21 CFR 200.50 (Eye drop and eye ointment manufacture)
    • GMP Annex 1 (Manufacture of Sterile Medicinal Products—EU)

    Typical usage ratio

    • 0.025% to 0.05% w/v, strictly standardized per drop for patient safety

    Downstream process integration

    • Sterile compounding, with oxymetazoline dissolved post-autoclave filtration
    • Physical and chemical stability evaluations, light transmission tests
    • Final fill under Class 100 cleanroom conditions for single-use or multi-dose vials

    Final product types

    • Eye redness relief drops (polyethylene or LDPE vials)
    • Combined anti-allergy formulations with antihistamines
    • Single-dose ophthalmic solution packs

    4. OTC Combination Cold Remedy Liquids

    In integrated cold remedy production, oxymetazoline serves as the active vasoconstrictor component in multi-symptom oral or topical formulas. Manufacturing workflows require compatibility checks with other active pharmaceutical ingredients, flavorants, sweeteners, and viscosity enhancers, as well as robust allergen and contaminant controls at the liquid blending and bottling stages.

    Industry compliance standards

    • USP-NF compound monographs—Combination OTC products
    • FDA Drug Facts Labeling (21 CFR 201.66)
    • Food and Drug Administration (FDA) Drug GMP (21 CFR 210/211) for combination medications
    • PIC/S GMP guidance for non-sterile liquids

    Typical usage ratio

    • Typically 0.025% w/v in oral or topical solution, adjusted based on total active pharmaceutical load and regulatory monograph

    Downstream process integration

    • Active addition following syrup base blending
    • pH control, blending of flavor and color, de-aeration, in-line filtration prior to bottling
    • Batchwise release QC for flavor, viscosity, stability profile, and uniformity

    Final product types

    • Multi-symptom cold relief syrups
    • Daytime and nighttime decongestant oral liquids
    • Pediatric cold relief mixtures incorporating antihistamines or antitussives

    5. Veterinary Nasal/Sinus Therapy Products

    Veterinary health product lines use oxymetazoline in nasal sprays and washes for livestock and companion animals with upper respiratory issues. Process design accounts for animal safety profiles, palatability, ease of administration, and compatibility with other veterinary actives. Products must be manufactured under VMPs with cross-species residue and side effect controls.

    Industry compliance standards

    • European Medicines Agency (EMA) Guidelines on Veterinary Medicinal Products (VMPs)
    • The United States Pharmacopeia—Veterinary Compendium
    • US FDA Center for Veterinary Medicine (CVM) Guidance for Industry
    • Good Manufacturing Practice (GMP) for Veterinary Products (VICH GL9)

    Typical usage ratio

    • 0.025%–0.05% w/v for nasal routes, concentration adjusted according to animal weight and application frequency following veterinary drug dossier

    Downstream process integration

    • Dissolution in physiological saline base under controlled agitation
    • Filling into animal-safe dosing containers after particulate removal and preservative dosing
    • Palatability trials, with chemical stability and sterility evaluations

    Final product types

    • Livestock nasal decongestant spray bottles
    • Companion animal intranasal delivery devices
    • Sterile sinus rinse ampoules for veterinary hospitals

    6. Hospital Use Mucosal Vasoconstriction Preparations

    Hospital compounding and surgical supply operations utilize oxymetazoline for intraoperative field vasoconstriction, especially in ENT and ophthalmic procedures. Preparation must meet hospital pharmacopoeia requirements for single-use, sterile solutions. Rigorous control over endotoxin and particulate levels is critical for direct mucosal application in clinical environments.

    Industry compliance standards

    • The United States Pharmacopeia Hospital Formulary requirements
    • Joint Commission standards for medication management
    • FDA 503B Outsourcing Facility Guidelines (US)
    • ISO 13408 (Aseptic processing of health care products)

    Typical usage ratio

    • 0.025% to 0.05% in buffered, sterile aqueous solution, prepared immediately prior to procedure as per hospital SOP

    Downstream process integration

    • Aseptic dilution and filtration within central pharmacy compounding units
    • Direct transfer to sterile surgical field containers
    • Rapid expiry product formats, produced per-case or batch for scheduled surgeries

    Final product types

    • Sterile intraoperative vasoconstrictor irrigation solutions
    • Single-dose mucosal swab vials for operating rooms
    • Small-volume hospital pharmacy compounded syringes or droppers
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    Certification & Compliance
    More Introduction

    Oxymetazoline: Our Direct Experience as a Chemical Manufacturer

    Our Approach to Oxymetazoline Production

    At our production site, Oxymetazoline represents more than a name on a drum or a line item on a shipment. We’ve watched this molecule cross multiple stages, from early synthesis steps focused on achieving high-purity intermediates, to finishing processes designed to produce a crystalline, stable compound. We have invested time and effort into in-depth process controls, guided by both regulatory compliance and the knowledge we have built from every batch. Over the years, our technicians have tested hundreds of samples to reach the consistently high standards demanded by the pharmaceutical sector.

    The Makeup of Our Oxymetazoline

    We manufacture Oxymetazoline hydrochloride mainly as a white crystalline powder. Most batches fall within a purity of 99.5%, checked regularly using HPLC and IR spectroscopy. The melting range typically lands in the low hundreds Celsius, and we check every lot for moisture content and specific impurities, looking beyond the minimum to identify subtle patterns that might signal room for improvement. The particle sizing is controlled within set ranges that customers in the pharmaceutical industry prefer for their blending and dissolution needs. Each bottle and drum comes with a full set of analytical data—ready for pharmaceutical or medical formulation, and cleared for import or export based on the region’s specifications.

    Experience Bringing Oxymetazoline to Market

    Years of making Oxymetazoline have taught us that details matter. Environmental conditions during preparation, cleaning and maintenance of reactors, and the skill of our operators all affect yield and cleanliness. Even small deviations in temperature or agitation speed can alter the product’s form or residual solvent content. Variations between raw materials, even from the most reputable suppliers, make it necessary to monitor every incoming shipment carefully.

    Each lot is tested at various stages—not just at the end—gathering information that we feed back into our standard operating procedures. Customers with strict GMP requirements benefit from our approach to recordkeeping and traceability. We don’t cut corners on data integrity or batch-to-batch consistency. That has helped us maintain approvals with most major pharmaceutical customers for well over a decade.

    Applications and End Uses

    Most of the Oxymetazoline we produce goes to companies formulating nasal sprays and decongestant drops. These formulations rely on rapid and robust dissolution, so particle control and purity are watched more closely than for many other intermediates. Pharmacies and hospital dispensing operations appreciate the extended stability profile, since Oxymetazoline hydrochloride resists breakdown under light and typical ambient conditions used during transport and storage. Some clients require sterile filtering on delivery, which we support with aseptically packaged material, filled under nitrogen to limit residual moisture.

    In topical preparations, Oxymetazoline brings the benefit of quick vasoconstrictive action, relieving swelling and redness from conditions like rhinitis, rosacea, and irritated skin. We work with research groups and innovation teams, offering custom quantities for clinical research or pre-market testing. We support documentation requirements with granular access to impurity profiles, stability protocols, and process validations, informed by years of engaging with regulatory inspections and client audits.

    Quality, Traceability, and Control

    Of all the products we manufacture, Oxymetazoline compels the most rigorous oversight. Failure to meet moisture content limits or contamination control would mean days of re-testing or even scrapping a batch. That level of risk supports our decision to maintain in-house testing rather than relying on offsite services. We run regular reference standard comparisons and review trending data from past batches.

    Traceability for each shipment is built into our ERP system. The chain of custody covers starting materials, equipment history, and operator sign-offs for each critical step, from synthesis through milling, packing, and shipping. We make the full batch history available for client review during audits. In the rare event a deviation arises, all supporting data gets put under the microscope to find the root cause. Our data-driven approach has reduced out-of-specification occurrences over the past five years, adding confidence for partners concerned about regulatory compliance.

    How Oxymetazoline Stands Apart

    As both producer and observer in this space, we see the differences between Oxymetazoline and similar compounds up close. Products like Xylometazoline or Naphazoline fill related niches, yet Oxymetazoline’s structure gives it superior receptor selectivity and a longer duration of action in most nasal applications. We monitor feedback and regulatory reports regarding tolerance, effective dose, and side effect profiles, staying ready to modify production or testing if best practices or legal standards shift. Compared with alternatives, our Oxymetazoline’s stability under typical humidity means fewer rejected bottles downstream, and customers rarely see caking or off-odor at receipt.

    From a technical standpoint, our process yields high-purity material with a low residual solvent level—well below ICH guidelines. We have experimented with alternative synthesis routes but found that our proprietary method produces the cleanest material and most predictable processing time. In side-by-side applications, formulators report more reliable nasal spray delivery properties, which results in less rework at their filling lines.

    Supporting Clients Beyond Supply

    We’ve grown to see our role as extending far past the factory gate. Many of our clients now involve us in early project planning and product development. We help identify potential pitfalls in formulation, packaging, and regulatory vetting. Our technical team offers in-person troubleshooting when process or stability issues arise. That support saves our partners time, especially when product development shifts to clinical batches or scale-up campaigns.

    We provide real-life data—such as historical yield, real impurity trends, or handling insights—that can’t be captured well in scientific papers or generic supplier brochures. By speaking honestly about challenges (what can go wrong, what corners not to cut, and which results to expect), we aim to be a steady resource for decision-makers. If changes to regulations or client specs come down, we run focused trials on our own dime to see what adjustments work. Deliveries get updated documentation and, if needed, new product codes to keep customers’ compliance records accurate.

    Environmental Responsibility in Manufacturing

    Growing awareness of environmental risk has shaped how our Oxymetazoline process operates today. Waste minimization and solvent recovery play leading roles in our methods. We target waste stream reduction, using closed loop solvent systems and responsible effluent treatment. Regulatory inspectors regularly review our data, and our site boasts an environmental management certification that guides every new project we build.

    Our team holds regular training on safe handling and spill containment. These efforts have cut reportable incidents to nearly zero. We keep our chemical inventory in line with actual consumption, buying and storing raw materials only as needed. This reduces the risk of container leaks and lowers the volume of surplus drums sitting on racks. Careful waste sorting, external audits, and third-party partnerships for safe disposal support a goal of minimizing lasting environmental impact.

    How Experience Influences Our Decisions

    Having direct, daily control over every stage of Oxymetazoline production gives us a perspective that traders and distribution partners often lack. We see in real time how small, practical choices affect outcome. For example, repeat training of operators leads to fewer mixing errors and lower contamination. Regular investment in lab upgrades pays back with clearer test results and early warning about any deviation. The decision to keep our process bottlenecks well documented lets us spot trouble before it grows into a customer-facing problem.

    Production runs often teach as much as textbooks. At high humidity, certain assumptions about product stability get proven wrong—so we adapted our controls. On occasion, supplies of key starting chemicals face disruption. The experience has trained us not to over-rely on single vendors, and to keep backup sources approved and validated. These lessons lead us to advise customers honestly about lead times and availability.

    Innovation, Limitations, and Industry Trends

    Although Oxymetazoline remains established in healthcare, the pressure to innovate keeps us on our toes. Researchers look for new delivery vehicles, and regulatory agencies worldwide update expectations for impurity control. We’ve followed current literature to understand emerging impurity risks and adopted elements of green chemistry where possible. We keep pilot equipment online for process tweaks, using them to support limited experimental runs before releasing any changes to full-scale production.

    We also watch the limitations: overreliance on legacy methods can block needed improvement, and there is sometimes pressure to increase throughput by pushing equipment to the edge of its design. Our stance prioritizes batch integrity over output numbers. When clients have needed variation—such as custom packaging or additional analytical tests—we bring their team into the plant so everyone can see what is possible and what compromises aren’t worth making.

    Risk Management and Business Continuity

    Long-term Oxymetazoline customers especially value reliability. We organize regular drills and business continuity exercises to test supply chain resilience. For key starting materials, safety stocks buffer disruptions upstream. Finished goods stay stored under optimal temperature and humidity control. Every shipment leaves with backup documentation, and our project managers keep a running risk register. If an unplanned delay ever arises, we don’t hide the reality but keep partners informed so they can adjust their logistics accordingly.

    This approach has made difference during volatile periods, whether due to regulatory changes or broader market shocks. Our transparency and planning have protected many of our customers’ own businesses. It’s common for long-standing partners to call us before starting site or process modifications, asking for specific Oxymetazoline technical input to avoid accidental disruption.

    Going Deeper Than Standard Specifications

    We recognize that specifications—particle size, assay, loss on drying—alone never tell the whole story for any real-life chemical. Information won in production guides testing priorities. For instance, learning that extended grinding introduces trace metals shaped our equipment material choices. Patterns in certain impurity peaks linked to incoming raw material purity have led to additional supplier audits, ensuring we start with the highest quality feedstock.

    Sometimes customers want bespoke forms, such as micronized grades or oxidant-free batches for special formulations. We collaborate closely through feasibility trials, not just sending a product but guiding through the process variables that will matter. That includes FDA and EMA-facing documentation support on request. We stand by findings with experience, not empty assurances.

    Trust that Comes from Making, Not Just Selling

    Every kilogram of Oxymetazoline we ship carries the weight of hands-on production expertise. Sales teams may focus on pricing or logistics, but production involves real materials, actual conditions, and human oversight. The result matters not just to us, but to the pharmacists, doctors, and patients who use or rely on downstream medication. We share what we know, shaped by both successful runs and the rare setback. This type of insight sets us apart in a crowded marketplace.

    Regular communication with regulatory authorities has honed our ability to track guideline shifts, whether on impurities, documentation, or storage conditions. Our culture puts quality, safety, and end-user experience at the front of every decision. We hold ourselves accountable, preferring to address a concern before it turns into a complaint or recall. We pass this confidence along to our partners by making available the expertise of our technical and quality staff.

    Meeting Today’s Challenges, Preparing for Tomorrow

    Oxymetazoline continues to see steady demand, and market feedback points to enduring trust in its safety and pharmacology. Still, global supply chains face constant pressure from policy, labor, and cost forces. We invest in real-time market intelligence, update safety and technical processes, and cross-train personnel to run more than one production line should needs shift. That flexibility proves its worth each time industry patterns change overnight.

    Questions of sustainability, energy usage, and regulatory compliance frame the future for all chemical producers. We have started implementing renewable energy options where possible, with monitoring to track savings and minimize the carbon footprint of each Oxymetazoline batch. We continue to work with universities and technical consortia that test new synthesis routes, striving to keep ahead not just on yield, but on safety and environmental impact as well.

    We’ve seen some shift toward digital monitoring, including process automation and data capture beyond what standard GMP asks. This digitalization increases traceability and gives earlier warning on batch outliers. Looking ahead, we expect more direct integration with customer systems to facilitate real-time supply chain planning and regulatory reporting.

    Listening and Growing Alongside Our Community

    Engagement with the scientific and manufacturing community sharpens our learning process. Participation in industry working groups, attendance at scientific symposia, and involvement in training events open us to feedback and new knowledge. Our continuing education budget supports site visits and operator certifications, keeping skill levels current with fast-changing technology. We invite customer partners to join workshops and site tours, exchanging perspective to help guide future projects.

    From formulating Oxymetazoline nasal sprays to running pilot studies for hospital suppliers, every project we take on adds to a reservoir of experience that no handbook teaches. Some of our longest-term clients credit our transparency and technical honesty for their own successful launches. We treat every order as part of an ongoing partnership, knowing that mutual learning and problem solving bring better results than any short-term deal.

    Oxymetazoline—A Product Shaped by Experience and Commitment

    Manufacturing Oxymetazoline puts us at the crossroads of science, regulation, and real-world use. The standards we uphold are earned batch by batch in the plant, not just adopted through paperwork. As a manufacturer committed to constant learning and open communication, we measure success by how reliably our partners bring their own high-quality, safe finished goods to market. Our legacy doesn’t rest on a brand or trademark—it centers on the accumulated knowledge and responsibility of everyone who takes part in making and shipping every gram. Through adaptation, skill, and accountability, we work to provide a product and partnership that stand up to scrutiny and provide value well beyond the specification sheet.