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N-Nitrosodibutylamine

    • Product Name N-Nitrosodibutylamine
    • Alias N,N-Dibutylnitrosamine
    • Einecs 204-660-8
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry admin@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    423586

    Cas Number 924-16-3
    Molecular Formula C8H18N2O
    Molecular Weight 158.24 g/mol
    Iupac Name N-nitrosobis(butan-1-amine)
    Appearance Yellow oily liquid
    Boiling Point 184 °C (363 °F) at 100 mmHg
    Melting Point -54 °C
    Density 0.887 g/cm3 at 20 °C
    Solubility In Water Insoluble
    Vapor Pressure 0.2 mmHg at 20 °C

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

    Packing & Storage
    Packing N-Nitrosodibutylamine is supplied in a 100 g amber glass bottle with a tightly sealed cap, clearly labeled with hazard warnings.
    Shipping N-Nitrosodibutylamine should be shipped in a tightly sealed, chemically resistant container, clearly labeled as hazardous. It must be transported in accordance with local, national, and international regulations for toxic, carcinogenic substances, preferably by certified hazardous materials carriers. Proper documentation and emergency response information should accompany the package to ensure safe handling in transit.
    Storage N-Nitrosodibutylamine should be stored in a cool, dry, and well-ventilated area, away from sources of ignition and incompatible substances such as strong oxidizers. Keep the container tightly closed and clearly labeled. Store in a dedicated, approved chemical storage cabinet, preferably designed for carcinogens and nitrosamines. Avoid exposure to light and moisture to maintain chemical stability and safety.
    Application of N-Nitrosodibutylamine

    Applications of N-Nitrosodibutylamine in Industrial Manufacturing

    N-Nitrosodibutylamine plays a limited but critical role in several industrial manufacturing processes, especially as a trace contaminant control target or as an unavoidable byproduct in specific chemical syntheses. Our direct production ensures consistent traceability and analytical support for customers requiring precise management according to global regulations.

    1. Rubber and Elastomer Manufacturing: Process Impurity Monitoring

    During vulcanization and compounding of nitrile-based rubbers, trace levels of nitrosamines including N-Nitrosodibutylamine may be formed as byproducts. Our expertise supports tire, hose, and medical device elastomer producers in tracking and minimizing these substances in compliance with international safety limits. We provide analytical-grade reference standards and knowledge transfer to optimize batch formulations and process conditions, ensuring end products meet all relevant toxicological thresholds.

    Industry compliance standards

    • European Regulation (EU) 2018/2005 (specific limits on nitrosamines in rubber teats and soothers)
    • U.S. FDA 21 CFR 177.2600 (specific migration limits for elastomer articles)
    • ISO 14362-1:2017 (methods for determination of specific nitrosamines)
    • Japan Food Sanitation Act – Notification No. 370 (rubber goods safety)

    Typical usage ratio

    • Not intentionally used; monitored as an impurity, detection sensitivity <10 ppb in finished rubber compounds. Mitigation relies on raw material selection and process parameters.

    Downstream process integration

    • Introduced only as a trace byproduct during reaction of dibutylamines with nitrosating agents in rubber mixing and vulcanization.
    • Routine batch QC sampling and GC-MS quantification are implemented post-curing.
    • We advise on safe process optimization to minimize formation during compounding and mold release.

    Final product types

    • Automotive tires
    • Medical examination gloves
    • Rubber baby bottle nipples
    • Industrial rubber hoses

    2. Agricultural Chemical Synthesis: Side-Product Control in Pesticide Manufacturing

    Certain agricultural active ingredient synthesis routes using nitrosating reactions or secondary amines can lead to N-Nitrosodibutylamine as an unintentional trace side-product. We support pesticide manufacturers who require validated analytical standards and consulting for process adjustment to comply with global residue and impurity guidelines. Our bulk reference material enables laboratories to calibrate their analytical systems and comply with industry audits.

    Industry compliance standards

    • OECD Test Guideline 487 (Ames Test for genotoxic impurities)
    • FAO/WHO Codex Alimentarius (max residue level specifications)
    • EU Regulation (EC) No 396/2005 (pesticide residue regulations)
    • Indian Insecticide Act Chapter VI (technical grade impurity profiles)

    Typical usage ratio

    • Not added as an ingredient. Detected as a trace contaminant—target level set by regulation, usually <0.1 mg/kg in technical active ingredient. Blending and process tweaks reduce presence.

    Downstream process integration

    • Arises in final product only through certain amine-based synthetic routes.
    • Customers implement regular monitoring during crystallization, filtration, or distillation steps.
    • We deliver high-purity reference solutions for method validation and process improvement studies.

    Final product types

    • Technical and formulated insecticides
    • Herbicide intermediates
    • Fungicide raw materials
    • Plant growth regulators

    3. Pharmaceutical API Synthesis: Unavoidable Genotoxic Impurity (GTI) Management

    API producers sometimes face trace nitrosamine formation via tertiary amine nitrosation during downstream synthesis or storage. Our capabilities help pharma clients identify, quantify, and control N-Nitrosodibutylamine within the framework of ICH M7 guidance for genotoxic impurities. We deliver traceable material and certified reference standards, while consulting on risk evaluation and advanced purification technology.

    Industry compliance standards

    • ICH M7 (R1): Assessment and control of DNA reactive (mutagenic) impurities
    • USP General Chapter <1469> (Nitrosamine Impurity Testing)
    • EMA Nitrosamine Q&A guidances 2023
    • Japanese PMDA GTI guidance for APIs

    Typical usage ratio

    • Present only as a process impurity; regulatory allowable intake typically 26.5 ng/day for patients (based on EMA risk assessment). Actual batch results usually <10 ppb in API. Monitored at every intermediate and final stage.

    Downstream process integration

    • Formed during advanced synthesis steps or following storage of precursors with secondary/tertiary amines.
    • Manufacturers apply step-wise impurity purge and robust analytical control supplied by our lot-specific reference standards.
    • Chemical and chromatographic decontamination integrated as required by client process design.

    Final product types

    • Small-molecule API for oral solid dosage forms
    • Injectable bulk intermediates
    • High-purity intermediates for oncology APIs
    • Complex amine-based synthetic building blocks

    4. Laboratory Analytical Calibration: Analytical Reference Standard

    Accredited analytical labs and quality control departments across pharmaceutical, environmental, and industrial sectors require N-Nitrosodibutylamine as a trace-level standard for method validation and calibration. Our certified batches feature traceability, batch-specific documentation, and impurity data, supporting laboratories in achieving high accuracy for nitrosamine screening according to current regulatory requirements.

    Industry compliance standards

    • ISO/IEC 17025 (testing and calibration laboratory competence)
    • USP, Ph. Eur., JP monographs for nitrosamine impurity testing
    • U.S. EPA Method 8270 (semi-volatile organic compounds by GC/MS)
    • GLP compliance for environmental and pharma contract labs

    Typical usage ratio

    • Supplied as 10-1000 µg/mL solution for calibration curves and spiking applications. Dilutions adjusted per method sensitivity and sample matrix.

    Downstream process integration

    • Used in instrument calibration, LOD/LOQ determination, method validation, and proficiency testing rounds.
    • Operators verify method performance prior to regulatory release or internal QC batch certification.
    • Primary reference for identifying contamination origin in root cause analysis studies.

    Final product types

    • Certified test reports
    • Release and stability documentation for pharmaceuticals and food
    • Environmental monitoring reports
    • Quality certificates for consumer product inspection
    Free Quote

    Competitive N-Nitrosodibutylamine prices that fit your budget—flexible terms and customized quotes for every order.

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    Certification & Compliance
    More Introduction

    N-Nitrosodibutylamine: Integrating Science and Responsibility in Chemical Manufacturing

    Decades of Experience Shape Our Approach

    Each compound carries a unique personality. N-Nitrosodibutylamine stands out as one of those specialty chemicals that demand careful stewardship, from the drawing board to the warehouse shelf. After years working on the frontlines of synthesis, formulation, and technical support, I have learned that not every customer seeks the same thing from N-nitrosoamines. Some approach looking for its baseline presence in environmental studies, others for use in research and analytical calibration. Its relevance in regulatory and health contexts makes it a subject of scrutiny and rigor, and manufacturers like us bear the responsibility to treat it with transparency and care.

    Specification Driven by Application Demands

    N-Nitrosodibutylamine, with a CAS number often checked against regulatory lists, wears a reputation that covers more than its chemical formula. At our plant, we focus on purity as the first metric, with a typical offering of 98 percent minimum purity. We reach for a low moisture content because excess water not only compromises the material but can also alter trace analysis in sensitive applications. Each lot is produced in strict isolation, with closed systems to control cross-contamination. Our technicians, many of whom have years behind them in the lab, know that analysts and researchers depend on lot-to-lot consistency. We prefer small to medium batches so we can audit each one against established reference standards.

    Production Experience: Beyond the Recipe

    Those outside the walls of the plant may picture chemical production as a set-it-and-forget-it operation. That’s rarely the truth. N-Nitrosodibutylamine requires careful temperature and pressure controls throughout synthesis and distillation. Minor shifts can change the impurity profile, so we rely on time-tested, manually monitored steps — not just sensors. Our team has learned to recognize the subtle color and odor differences that confirm a well-finished batch, and each run concludes with a full suite of identity and purity checks using validated GC and HPLC methods. Analytical chemists on staff cross-check with spiked samples and reference materials to confirm results before signing off each release.

    Meeting Research Needs: Usage Keeps Evolving

    Over time, we’ve seen calls for N-Nitrosodibutylamine come from universities, regulatory laboratories, food safety researchers, and even analytical instrument vendors. Its main uses today orbit around analytical calibration and method validation, particularly for environmental and food testing. By providing a known concentration of this compound, labs can measure very low-level nitrosamines in everything from water to smoked meats. Its defined chemical behavior helps quality assurance teams test new detection methods in chromatography. There are times when government agencies request this compound as part of larger reference mixes, enabling them to simulate complex sample matrices.

    Some industrial customers use the compound to benchmark their own internal controls, checking potential contamination sources or practicing new sampling and extraction methods. We’ve also seen requests for use in interlaboratory proficiency testing, where consistent, reliable batches give fair comparison points across multiple agencies or research sites. No matter the end use, feedback from customers—whether they’re in Europe or Asia, a food safety authority or university research group—has helped us fine-tune our specifications and packaging.

    Differences from Other Nitrosamines

    As you run down the list of known nitrosamines, the structural differences play a huge role in analytical behavior, volatility, and potential toxicology. N-Nitrosodibutylamine, with its dibutyl structure, has a higher molecular weight than some of its relatives like N-Nitrosodimethylamine or N-Nitrosodiethylamine. This leads to a higher boiling point, which influences how it behaves during distillation and analysis. In our production experience, it cleans up more slowly in fractional distillation — the tails and heads require finer attention, or you risk impurity carryover.

    Toxicologists flag N-Nitrosodibutylamine in regulatory documents as a probable carcinogen, and research shows that structure-activity relationships among nitrosamines make their behavior hard to predict without direct study. Its relative bulk means it partitions differently during environmental sampling; it has less volatility and can persist longer in soils or sediments compared to lighter nitrosamines. These physical factors mean analysts often tweak instrument methods when testing for this specific agent rather than using a “catch-all” technique. We hear from labs that switching from one nitrosamine to another is never trivial—calibration curves shift and matrix effects change.

    Packing, Handling, and User Feedback Shape Our Process

    Packing and transport present another layer of complexity. Nitrosamines do not tolerate casual handling; regulatory controls restrict their movement and storage. We use amber-glass containers with Teflon-lined closures, not as a default but based on actual field experience, which shows that even trace interaction with plastics can leach contaminants or cause analyte loss. Shipments include tamper-proof seals, and temperature tracking for longer journeys. Laboratories have told us that easy-to-open closures help reduce exposure risks, so we have adopted ergonomic caps that technicians can remove with gloves.

    Regular audits and user site visits have told us where the bottlenecks lie. Poor labeling and ambiguous documentation not only frustrate users but heighten safety risks. Our technical data sheet prioritizes clear language—listing purity, major and minor impurities, and relevant analytical parameters confirmed by certificate of analysis. Newer customers sometimes ask for detailed material history and chain-of-custody documentation; we maintain batch records for years, even long after shipping, because regulatory reviews can demand traceability long after the bottle has left our site.

    Regulatory Climate and the Need for Traceability

    Nitrosamines in general, and N-Nitrosodibutylamine specifically, now face more regulatory scrutiny than they did a decade ago. Regional agencies in Europe, the US, and Asia require pre-notification before import, comprehensive hazard labelling, and strict occupational exposure limits. Anyone who has had an unscheduled audit knows that incomplete batch records or missing purity data can halt an entire delivery chain, causing lasting financial and reputational risk.

    To keep pace, our compliance officers review global hazard statements and update our packaging and supporting documents. We have adopted GHS labeling, not just to tick a box but because we’ve seen how it improves clarity for warehouse staff, customs inspectors, and end users. Batch-specific SDS documentation accompanies every order, and periodic third-party audits validate our controls. With regulatory rules and guidance often revised with little warning, we have invested in training for staff on updates and best practices. It’s not just about handing over a product—it’s about standing behind it, long after delivery.

    Safety Experience: Efforts Beyond Minimum Compliance

    As chemical manufacturers handling N-Nitrosodibutylamine, our safety culture—honed over decades—builds on a hard-earned foundation. Nitrosamines like this one pose real hazards. We train new operators not only on PPE standards but also on specific emergency drills relevant to our plant layout. Over the years, investments in vapor detection systems and dedicated air handling for nitrosamine production lines have paid off many times. Staff involvement in near-miss reporting and root-cause analysis keeps our record strong; the best safety measures often come from the sharp observations of those working directly with the chemical.

    Waste minimization and environmental controls always shape our process. Residuals and off-spec product don’t simply disappear; they require controlled neutralization and secure disposal paths. State and federal regulators demand chain-of-custody logs for disposal partners, so we apply the same traceability to waste streams as to bulk product. Water-efficiency upgrades and solvent recycling started as small pilot projects but now form core elements of our day-to-day work.

    Challenges in Manufacturing: Learning from Mistakes

    Lessons in chemical manufacturing often come at a cost, and nitrosamines magnify those risks. Years ago, a process upset in our pilot reactor led to the formation of uncharacteristic by-products, requiring weeks of re-work and analysis to confirm we hadn’t introduced an unanticipated hazard or impurity. Traceability, at that point, meant retracing every procedural step, raw material source, and cleaning record. After that incident, we tightened verification steps for every incoming precursor material, building redundancy into both manual and system checks.

    Customers on international projects began asking about pharmaceutical-grade input materials, even for research-grade nitrosamine. The result? A new qualification protocol for suppliers, with direct observation of incoming lot certifications, forcing some difficult conversations with long-term partners. In time, the business stabilized, but only after accepting that safeguarding product quality required more time—and cost—than some in management first thought. Reliability became an investment more than an expense.

    The Role of Feedback and Collaboration

    Face-to-face time with customers—whether at technical conferences, site audits, or even troubleshooting phone calls—has changed the way we work. Analytical chemists in government labs once pointed out inconsistencies in reported impurity data. Their findings pushed us to overhaul certain in-process analytical techniques. No lab’s instruments work exactly the same; methods drift over time and matrix differences can affect results. Sharing raw chromatograms, not just summary data, became common practice so that end users could trust the numbers they report.

    On another front, instrument manufacturers asked us for specially diluted standards of N-Nitrosodibutylamine for calibration sets. These requests showed how broad the user base really is – from water labs to major instrument vendors. Each request added nuance to our product line, teaching us that batch size and concentration flexibility matter. Customer requests led us to lower-volume packing, intermediate dilutions in acetonitrile or methanol, and more comprehensive lot files, which support audits and research publications.

    Addressing Concerns about Carcinogenicity and Environmental Fate

    Public concern over nitrosamines has grown, and rightfully so. As a probable human carcinogen, N-Nitrosodibutylamine commands respect not just in the plant but throughout its life cycle. We follow published studies from regulatory bodies and academic researchers, reviewing every new article and risk assessment. Regular hazard reviews pull in environmental persistence data, degradation kinetics, and toxicology findings – all of which inform our process improvements.

    Dealing with such a persistent and potentially hazardous chemical means not just storing it safely, but also thinking about post-use pathways. We offer collection programs for spent stocks, supporting safe destruction and waste minimization at the laboratory level. With our customers, we share best practices for in-lab storage, secondary containment, and—where possible—chemical neutralization, recognizing that even small environmental releases can have outsize impacts.

    Long-Term Vision: Building a Responsible Supply Chain

    Our experience tells us that supply chain reliability is as crucial as technical excellence in chemical manufacturing. Sourcing precursors for N-Nitrosodibutylamine depends on strong relationships with vetted suppliers who provide transparent data and open their doors for audit. Unstable supply lines raise risks, so we commit to regular site visits and third-party inspections, not as a formality, but because firsthand observation exposes early warning signs of trouble.

    Technology modernization continues to shift older synthesis routes toward greener alternatives. Though the core synthetic scheme of N-Nitrosodibutylamine has not changed dramatically for decades, incremental improvements matter. Newer catalysts, better solvent recovery, and advanced process analytical technologies allow tighter control and lower emissions. Some users now ask for documentation on “greener” production as part of their supplier evaluation, driving industry-wide demand for smarter engineering.

    The Human Element Remains Central

    No process or protocol replaces the insight gained by those who have run the systems and solved the problems. The motivation to continually improve our manufacturing of N-Nitrosodibutylamine owes as much to the collective knowledge of our operators as to the scientists refining the analytics. Managers and field staff both participate in root-cause reviews, and team members who point out complications or risks are recognized and heard. This culture encourages ownership, continuous learning, and resilience even under pressure.

    The Path Forward: Opportunities for Collaboration

    N-Nitrosodibutylamine does not offer the broad industrial application of some commodity chemicals, but its specialized use means careful handling, technical support, and compliance to high standards. By working with both long-standing and newer customers, listening to their challenges in method development, storage, or disposal, we keep our product relevant and safe. As regulations evolve, demands for transparency and data integrity grow. Maintaining open lines of communication and sharing field experience with regulators, researchers, and technical staff helps create better frameworks—for safety, quality, and environmental stewardship.

    From personnel at the lab bench to legislative authorities, the future of N-Nitrosodibutylamine production relies on a blend of scientific rigor, real-world experience, and open dialogue. Each improvement—whether in purity, safety, documentation, or environmental footprint—traces back to that fundamental principle: making high-standard chemistry available while acknowledging and addressing its real-world risks. We see our role not just as suppliers, but as contributors to the ongoing dialogue about responsibility, science, and confidence in specialty chemical supply.