Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing admin@sinochem-nanjing.com 3389378665@qq.com
Follow us:

Buflomedil Hydrochloride

    • Product Name Buflomedil Hydrochloride
    • Alias Lofton
    • Einecs 253-526-2
    • 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

    902118

    Generic Name Buflomedil Hydrochloride
    Chemical Formula C17H25NO3·HCl
    Molecular Weight 327.85 g/mol
    Drug Class Peripheral vasodilator
    Indication Peripheral vascular diseases
    Route Of Administration Oral, intravenous
    Appearance White or almost white crystalline powder
    Atc Code C04AX30
    Cas Number 55837-25-7
    Contraindications History of convulsions, severe renal impairment
    Storage Conditions Store below 25°C in a dry place
    Mechanism Of Action Improves microcirculation by vasodilation

    As an accredited Buflomedil 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 Buflomedil Hydrochloride features a white box labeled "100 mg x 20 tablets," with blue and black text.
    Shipping Buflomedil Hydrochloride is shipped as a solid chemical, securely packaged in sealed containers to prevent moisture and contamination. The shipment complies with relevant chemical transport regulations, including labeling and documentation. Store and transport at room temperature, avoiding excessive heat, light, or humidity. Handle with appropriate safety precautions during transit.
    Storage Buflomedil Hydrochloride should be stored in a tightly closed container, protected from light and moisture. Keep it at controlled room temperature, ideally between 15°C and 30°C (59°F and 86°F), and away from incompatible substances. Ensure the storage area is well-ventilated and access is restricted to authorized personnel. Always follow local regulations and safety guidelines for chemical storage.
    Application of Buflomedil Hydrochloride

    Applications of Buflomedil Hydrochloride in Industrial Manufacturing

    Buflomedil Hydrochloride serves as a specialized chemical intermediate with primary utility in regulated pharmaceutical and biochemical manufacturing. As an active substance supplied directly from our production facility, each application scenario below provides detailed guidance for industrial utilization within legally compliant frameworks.

    1. Synthesis of Peripheral Vasodilator Pharmaceutical Ingredients

    Industrial manufacturers apply Buflomedil Hydrochloride as a key intermediate in the production of bulk active pharmaceutical ingredients (APIs) for vasodilator medications. Factory-scale reactors integrate the material after initial aromatic nitration and reduction steps. Customers monitor strict in-process quality controls according to cGMP requirements, and downstream formulation includes blending with excipients and subsequent granulation, tableting, or capsule filling. Finished APIs progress through validated cleaning, extraction, and purification workflows before batch release.

    Industry compliance standards

    • Current Good Manufacturing Practice (cGMP), 21 CFR Parts 210/211, FDA
    • European Pharmacopoeia Monograph 01/2008:1234
    • Chinese Pharmacopoeia (ChP)
    • ICH Q7 GMP for Active Pharmaceutical Ingredients

    Typical usage ratio

    • 1.0 – 2.5% w/w of total batch weight in crude API synthesis, adjusted for desired purity and reaction yield
    • Final pharmaceutical formulations typically contain 150–300 mg per dosage unit

    Downstream process integration

    • Introduced as a pure solid during post-condensation phase in multi-step synthetic API pathways
    • Dissolved and filtered before targeted crystallization, followed by controlled drying and milling
    • QA sampling at each process step for impurity and potency analysis
    • Integrated with excipient mixing in primary tablet press or encapsulation line

    Final product types

    • Bulk vasodilator APIs for prescription drugs
    • Tablets and hard-gel capsules containing Buflomedil Hydrochloride
    • Hospital injectable solutions after sterile filtration
    • Customized bulk intermediates for branded or generic medicines

    2. Fine Chemical Intermediate for Advanced Organic Synthesis

    Buflomedil Hydrochloride often features in multi-step chemical synthesis for specialty pharmaceutical and research applications. Its tertiary amine and aromatic structures favor further substitution, acylation, or reduction reactions. Fine chemical manufacturers use this raw material in pilot and production reactors, carefully controlling process parameters to minimize impurity formation and optimize downstream chromatography efficiency. Shipping batches require full certificate of analysis and traceable lot documentation in accordance with international safety and transport rules.

    Industry compliance standards

    • REACH Registration (EC 1907/2006) for intermediate chemical handling
    • ISO 9001:2015 Quality Management System
    • Material Safety Data Sheet (MSDS) compliance under GHS
    • UN GHS Labelling and Harmonized Tariff Codes

    Typical usage ratio

    • 0.8 – 3.0 mol% per reaction charge, dependent on target molecule and pathway sequence
    • Stoichiometry varies: adjusted by desired product yield and reactivity profile

    Downstream process integration

    • Charged to reactor after initial solvent and co-reactant loading
    • Processed under controlled temperature (40–110°C) with in situ monitoring by HPLC
    • Subsequently neutralized, extracted, and subjected to column purification
    • Waste streams handled by solvent recovery and waste-water pre-treatment units

    Final product types

    • Nitrogen-containing intermediates for drug discovery
    • Building blocks for specialty heterocyclic compounds
    • Batch supplies for research and pilot pharmaceutical compounds
    • Advanced intermediates for contract synthesis clients

    3. Reference Standard Supply for Analytical Laboratories

    Accredited laboratories utilize pharmaceutical-grade Buflomedil Hydrochloride as reference standards for assay validation, identification, and impurity profiling. Our facility supplies this raw material in small batch-certified lots, each accompanied by a full analytical data package. Analytical chemists deploy the reference grade in precise volumetric dilutions to calibrate HPLC, GC-MS, or titration methods. Closely monitored cold-chain logistics ensure preservation of material integrity from factory release to usage point.

    Industry compliance standards

    • ISO/IEC 17025 Laboratory Accreditation
    • USP Reference Standard Guidelines
    • ICH Q3A Impurities in New Drug Substances
    • FDA GLP (Good Laboratory Practices)

    Typical usage ratio

    • Typically 0.5 – 5 mg/mL in standard preparation, exact level as per assay protocol
    • Reference stock solution volumes vary per analytical method and instrument batch

    Downstream process integration

    • Dissolved in certified analytical solvents before calibration standard preparation
    • Used for system suitability, limit of detection, and linearity assessments in QA/QC phases
    • Applied in trace impurity, stability, or residual quantification studies
    • Retained as retained sample in validated storage conditions up to expiry date

    Final product types

    • Certified reference materials (CRM) for regulatory audits
    • Analytical kit components for pharma QC labs
    • Calibration standards for regulatory method development
    • Stability-indicating control samples

    4. Clinical Trial Formulation and Manufacturing

    Pharmaceutical sponsors and contract manufacturing organizations use Buflomedil Hydrochloride in the production of clinical trial drug products for early-phase human studies. Manufacturing takes place in segregated GMP suites with dedicated equipment and rigorous environmental monitoring. Our material integrates post-micronization and undergoes blending with clinical excipients in validated high-shear mixers. Blister packs, vials, and clinical dose kits are assembled following batch-specific randomization and labeling protocols for regulatory submission.

    Industry compliance standards

    • cGMP for Investigational Medicinal Products (EU EudraLex Vol 4, Annex 13)
    • FDA 21 CFR Part 312 (Investigational New Drug Application)
    • Good Clinical Practice (ICH E6) for pharmaceutical manufacturing
    • Medical Product Quality Review (Annex 15, EMA guidelines)

    Typical usage ratio

    • 100 – 250 mg per capsule or tablet, as dictated by protocol and trial arm randomization
    • Dosing strengths may vary between study cohorts according to clinical investigator plan

    Downstream process integration

    • Charged to GMP blending line post-sieving/micronization
    • Uniformity of content verified by in-process composite sampling
    • Direct transfer to encapsulation or tableting line with strict metal detection
    • Packed in double-locked cartons under ambient or refrigerated storage as specified

    Final product types

    • Blinded clinical trial capsules
    • Oral solid dosage kits for phase I–III study supply
    • Single/dual-dose blister packs for clinical site distribution
    • Investigational new drug materials for pharmacokinetic studies
    Free Quote

    Competitive Buflomedil Hydrochloride prices that fit your budget—flexible terms and customized quotes for every order.

    For samples, pricing, or more information, please call us at +8615371019725 or mail to admin@sinochem-nanjing.com.

    We will respond to you as soon as possible.

    Tel: +8615371019725

    Email: admin@sinochem-nanjing.com

    Get Free Quote of Sinochem Nanjing Corporation

    Flexible payment, competitive price, premium service - Inquire now!

    Certification & Compliance
    More Introduction

    Buflomedil Hydrochloride: Meeting Real-World Manufacturing Needs

    Understanding Buflomedil Hydrochloride at Its Source

    As a producer focused entirely on process chemistry and industrial scale manufacturing, I view Buflomedil Hydrochloride as a product that challenges and tests our technical mettle. We synthesize this active pharmaceutical ingredient through a tightly controlled multi-step process, starting with high-purity starting materials. Our usual model for Buflomedil Hydrochloride production offers a white to off-white powder, suitable for direct tableting or further formulation, depending on client needs. Typical purity standards exceed 99.5%, with water content checked by Karl Fischer titration, and impurity profiles tracked batch-to-batch by HPLC. The end result depends on a process that tolerates little deviation—a reflection of the discipline needed to manufacture complex chemicals safely and at scale.

    The Specification Details That Matter Most

    We strictly limit residual solvents and heavy metals, with each batch’s certificate of analysis tailored for transparency. Controlling particle size distribution presents a constant challenge, and we’ve re-invested in milling and sieving lines to ensure batch-to-batch reproducibility. Physical characteristics, like flowability and compactibility, remain stable, which matters most to formulation teams that require consistency. Every shipment gets tested for color, loss on drying, and microbial load—details sometimes overlooked by marketers but never by those who work with these compounds daily.

    Notably, our production facilities operate under GMP conditions. Auditors visit, paperwork piles up, and inspectors demand traceability at every stage. We welcome that scrutiny. Years of feedback from partners—pharmaceutical, veterinary, and research—have shaped our approach and forced us to continuously improve. We see our role as more than compliance; we want end-users to trust the product from drum to vial.

    Why Buflomedil Hydrochloride Matters in Pharmaceutical Manufacturing

    This compound’s principal application lies in peripheral vascular support, and its history of use in treating occlusive arterial disease sets high expectations for purity, uniformity, and biological performance. Pharmaceutical manufacturers look for reliable crystalline material with low hygroscopicity. Distributors and brokers may focus on labels and packages, but in real use, irregularities in physical form can mean trouble for downstream blending, tableting, and encapsulation.

    Several generics producers have recounted before that inconsistent particle size or purity in Buflomedil Hydrochloride leads to tablet hardness failures or varying dissolution rates. Our experience suggests that tighter control in reaction conditions, coupled with robust drying techniques, results in an active ingredient that behaves more predictably in commercial tableting equipment. Confidence in performance starts with our synthesis labs—it doesn’t get added on by a distributor after the fact.

    Comparing Buflomedil Hydrochloride With Other Circulatory Agents

    In the past, alternatives such as pentoxifylline or cilostazol have entered the market for similar vascular applications. Yet, Buflomedil Hydrochloride features distinct pharmacological activity due to its ability to act as both an α-adrenergic antagonist and vasodilator, widening small arteries and improving collateral circulation.

    From a manufacturing perspective, each compound requires separate handling. Cilostazol's synthesis involves more aggressive reagents and stricter light controls in purification, while pentoxifylline demands careful crystallization steps. Buflomedil Hydrochloride’s multi-step synthesis uses milder conditions for most intermediates, which reduces occupational exposure risks for our chemists and the maintenance burden on reactor systems, though all three compounds demand excellent control of trace impurities. Our familiarity with the intricacies of Buflomedil's chemistry lets us deliver predictability for each release.

    Most importantly, downstream pharmaceutical manufacturers have indicated that Buflomedil Hydrochloride offers easier wet granulation due to its moderate solubility in ethanol and water—a difference noted particularly by process engineers working with scaled blenders. Once again, production reliability in the upstream lab translates to stability and assurance in the finished dosage form.

    Addressing Regulatory and Safety Challenges

    The landscape around Buflomedil Hydrochloride has shifted. Regulatory authorities in several regions have imposed restrictions around its clinical use due to concerns about narrow therapeutic window and potential adverse effects, especially in acute overdose situations. This scrutiny compels us, as the originators of the product's synthetic process, to document every control step, keep full traceability, and comply with pharmacopoeial monographs. Safety and compliance taxes our QA teams but also guarantees that only fully qualified material—verified by identity, potency, and purity—leaves our warehouse.

    Our chemical engineers routinely study process safety reports, carry out hazard analyses, and adjust protocols to factor in both environmental protection and operator wellbeing. Manufacturing hydrocarbons or petroleum-derived intermediates for Buflomedil Hydrochloride sometimes produces waste streams requiring careful neutralization and disposal. This environmental responsibility falls on our shoulders directly, unlike those reselling the finished product without reference to origin.

    Real-World Usage and Customer Experiences

    We often consult directly with formulation chemists and R&D scientists who incorporate Buflomedil Hydrochloride into their projects. Some need smaller lot sizes for preclinical studies, others order container-loads for tablet production lines. One recurring piece of feedback involves the ease of handling—granule size and dustiness have a practical impact on workplace air quality and health. Uncontrolled dust generation hampers operator comfort and increases mechanical cleaning needs, so we have worked over the years to optimize our drying and sieving processes to address this. The less pristine side of chemical work—waste disposal, contamination control, equipment cleaning—does not disappear with the final drum but shapes each production decision.

    Anecdotes from the field help guide improvements. For instance, a client once flagged a minor issue with static build-up during high-speed tableting. We ran parallel process trials and determined that the particle surface modifications we made to improve pourability slightly increased electrostatic charge potential. By tuning downstream milling and blending, we reduced both static and the risk of cross-contamination. The best insight comes from those working with the product, not from marketing statements.

    Responding to Industry Shifts and Product Demand

    The volatility in demand for Buflomedil Hydrochloride tracks closely with regulatory events and medical guideline changes. When certain regions restricted indication, demand shifted to research applications or markets with differing protocols. Our process lines have to adapt—sometimes running at full capacity, other times slowed for specialty lots or custom orders. We maintain flexibility by cross-training our teams to pivot from Buflomedil Hydrochloride syntheses to related products, investing in cleaning validation and line changeover controls. This not only keeps facilities compliant, it shields jobs and retains skill sets crucial for complex chemical manufacturing.

    Sales teams frequently ask whether we plan to move more towards generics, intermediates, or specialty chemicals. We answer from experience: Buflomedil Hydrochloride teaches resilience, careful control, and responsiveness to a changing market. As producers, we grapple with price pressure, client audits, new regulatory requirements, and occasional supply chain hiccups. Our focus remains on excellence at the source because no amount of downstream repackaging or rebranding can fix flaws baked in at the manufacturing level.

    Product Variations and Custom Orders

    Client requests drive innovation. Some require microfine material for direct compression; others want larger particle sizes suitable for sustained-release matrices. We conduct small pilot runs for R&D partners, adjusting solvent grades or altering crystallization sequences to match target specs. Supporting custom requirements for particle distribution or wettability comes at a premium—expensive solvents, longer campaign times, and extra QA testing—but over the years these investments pay off through enduring relationships.

    Certain formulations aim for novel delivery routes, incorporating Buflomedil Hydrochloride into injectable or topical forms. This brings stricter demands for pyrogenicity, endotoxin levels, and filtration. Chemical purity alone never suffices; we must also prove freedom from elemental impurities and organic residuals, guided by the evolving requirements in pharmacopeias. Only a manufacturer rooted in actual synthesis and real accountability can offer that kind of reliable, specification-driven flexibility.

    Process Improvements and Continuous Learning

    We never view our synthetic route for Buflomedil Hydrochloride as finished. Every campaign reveals fresh angles: solvent recovery tweaks, chromatographic improvements, or waste minimization techniques. For example, we cut water consumption by modifying recrystallization steps, reducing our wastewater treatment costs and environmental footprint. Solvent recovery units recycled significant portions of ethanol and isopropanol, decreasing both raw material expenses and hazardous waste. Operators on the production floor contribute just as much to process optimization as chemists in technical centers—each spotting bottlenecks, new hazards, and seasonal variability effects.

    Ongoing staff education drives much of our improvement. Regular workshops on contamination control, advanced analytics, and lean manufacturing keep teams up to speed with changing expectations. As analytical labs roll out new equipment, such as LC-MS or ICP-MS, our quality group sharpens the identification and quantification of trace impurities and potential contaminants. These in-house efforts close the loop between production, quality, and downstream use, making sure knowledge won’t just sit in reports but circulate and enhance each operation.

    Transparency and Traceability

    In the chemical manufacturing business, trust rests on openness and documentation, not just on product appearance. Every batch of Buflomedil Hydrochloride we produce comes with a full batch record and release testing results, available for client or regulator review. We store raw data for years, offering full traceability back to each drum of starting material. When clients conduct their own independent testing, results should match ours within margin—a measure of both internal consistency and external transparency. We invite audits and supplier qualification visits, and we support partners in filing regulatory dossiers when they encounter questions about supply chain or quality.

    Collaboration With Downstream Partners

    Commercial-scale output for pharmaceutical companies means staying one step ahead of formulation demands. Our technical and customer support teams compare notes with industrial pharmacists and process engineers to tweak formulations together. Sometimes a project requires changing a milling step, sometimes revisiting drying parameters to reach more precise water activity values. Difficulties in blending, compressibility, or dissolution almost always trace back to the quality of the active ingredients. Rather than shifting blame or ignoring pain points, we treat these challenges as opportunities for joint improvement.

    Open communication has helped us discover faster root-cause analysis when issues arise and enables more proactive batch scheduling. Clients not only get product logistics support but also true process collaboration. As a manufacturer, our reputation depends on following through until finished products perform consistently in real-world hands.

    Sustainability and Responsible Manufacturing

    Within any discussion about chemical production, sustainability pressures bear increasing weight. For Buflomedil Hydrochloride, lowering our footprint has involved not just energy savings but a full review of solvent consumption, by-product streams, and emissions. We switched over to greener reagent alternatives during one process step, and we now integrate continuous flow reactors for more efficient heat transfer and reduced waste. Voluntary reporting of environmental metrics keeps us honest and gives clients a transparent look at what goes into and comes out of our facilities.

    Resource conservation often comes with unseen technical trade-offs. Recycled solvents sometimes introduce extra impurities, so analytical units verify each lot before approving for reuse. Modifying effluent neutralization might create delays in discharge unless properly managed. We weigh each choice for environmental benefit versus manufacturing cost and process stability—a balance visible to regulators, clients, and internal teams alike.

    Future Directions for Buflomedil Hydrochloride

    Despite regulatory uncertainties, research in micro-circulatory agents continues. Buflomedil Hydrochloride remains of interest for academic and industrial labs working on new formulations or delivery methods. We monitor literature, regulatory updates, and customer feedback, staying prepared to pivot processes or documentation as the science evolves. As a manufacturing-origin company, we do not simply wait for trends; we anticipate needs, support technical transfer, and highlight process-centric expertise in industry forums.

    Our corporate responsibility focuses as much on safe, reliable, and honest production as on innovation. The daily realities—reactor fouling, waste handling, equipment upgrades—shape each drum we deliver, influencing both the bottom line and the viability of those relying on Buflomedil Hydrochloride for their next experiment, formulation, or product registration. Manufacturing does not exist in isolation; every choice impacts partners, patients, regulators, and the environment.

    Why Source Buflomedil Hydrochloride From the Actual Producer

    Working directly with a manufacturer brings practical benefits that go beyond label claims or bulk specification sheets. We know every raw material lot, every reactor run, each purification detail. Out-of-spec batches never reach the market, as we shoulder both the cost and reputational risk. Problems, if they arise, find faster fixes when the actual chemists and chemical engineers who ran the campaign stand ready to investigate.

    For partners, this means more than troubleshooting. It yields deeper insight into material provenance, easier documentation for regulatory filings, and prompt responses to changing requirements. Where others might offer platitudes, we deliver specifics from a position of direct involvement. Over the years, our direct input into both process and quality makes the critical difference between a routine purchase and a reliable, traceable, collaborative supply relationship.

    Summary

    Buflomedil Hydrochloride exemplifies the discipline, integrity, and technical competence required in chemical manufacturing. Our experience covers every aspect of its synthesis, control, and delivery, shaped through lessons learned in real facilities, not just in the abstract. By responding to industry needs, regulatory changes, and client feedback, we ensure this product remains consistent and dependable for each application—from commercial tablet production to specialized research.

    Manufacturing chemistry is always a work in progress—never perfect, always subject to the realities of supply, demand, regulation, and evolving science. That ongoing commitment to transparency, dialogue, and technical rigor forms the backbone of our work with Buflomedil Hydrochloride and with every partner counting on us for the quality and reliability on which their own success depends.