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Phenformin Hydrochloride

    • Product Name Phenformin Hydrochloride
    • Alias DB00981
    • Einecs 205-814-1
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry sales7@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    464890

    Chemical Name Phenformin Hydrochloride
    Molecular Formula C10H15ClN2
    Molecular Weight 198.69 g/mol
    Appearance White to off-white crystalline powder
    Solubility Freely soluble in water
    Cas Number 834-28-6
    Therapeutic Class Antidiabetic agent (Biguanide)
    Route Of Administration Oral
    Storage Conditions Store at room temperature, 15-30°C
    Mechanism Of Action Decreases hepatic glucose production and improves insulin sensitivity

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

    Packing & Storage
    Packing Phenformin Hydrochloride, 25 grams: Sealed amber glass bottle with tamper-evident cap, labeled with hazard warnings, batch number, and expiration date.
    Shipping Phenformin Hydrochloride is shipped in tightly sealed, chemically resistant containers to prevent moisture and contamination. It is classified as a hazardous material and transported according to regulatory guidelines, including labeling and documentation. Handling precautions and temperature controls may be applied to ensure product stability and safety during transit.
    Storage Phenformin Hydrochloride should be stored in a tightly closed container, protected from light and moisture. Keep it in a cool, dry place at a temperature between 2°C and 8°C (refrigerated conditions). Ensure good ventilation and segregate from incompatible substances. Proper storage maintains the chemical’s stability and efficacy, and prevents hazardous degradation or accidental exposure.
    Application of Phenformin Hydrochloride

    Applications of Phenformin Hydrochloride in Industrial Manufacturing

    As the manufacturer, we supply phenformin hydrochloride strictly for regulated industrial and research uses, supporting downstream producers focused on specialized areas in pharmaceutical and diagnostic intermediate manufacturing. Below are representative application scenarios that reflect the actual use cases, industrial standards, formulation guidelines, processing steps, and end product options for phenformin hydrochloride on the international market.

    1. Active Pharmaceutical Ingredient (API) Intermediate for Anti-Diabetic Drug Synthesis

    Industrial-scale pharmaceutical companies historically used phenformin hydrochloride as an intermediate in the synthesis of oral anti-diabetic agents, primarily during the manufacture of high-purity API lots for regulatory submission, niche research applications, or legacy contract manufacturing where phenformin-based APIs remain permitted under local regulatory guidelines. Phenformin is introduced in controlled batch synthesis, precisely measured for integration during the heterocyclic amine step, with in-process quality control determining each lot’s appropriateness for downstream conversion to finished dosage forms, as permitted under specific country regulations.

    Industry compliance standards

    • Ph. Eur. (European Pharmacopoeia; for historical reference)
    • United States Pharmacopeia (USP, if applicable by region)
    • CFDA standards (for permitted legacy usage in designated territories)
    • GMP (Good Manufacturing Practice) for API manufacturing

    Typical usage ratio

    • Typically 20%–35% by weight of the total blend in pre-tablet intermediate formulation; adjusted depending on target drug strength and allowed daily dosage limits as specified by downstream regulatory filings.

    Downstream process integration

    • Incorporated during secondary amination and crystallization steps following primary raw material batch treatment; used as a direct reactant prior to salt formation and purification.

    Final product types

    • Solid oral anti-diabetic preparations (e.g., tablets) in regulated markets with approved phenformin use
    • Clinical trial materials for research projects or comparators
    • API supply for contract development and manufacturing organizations (CDMOs)
    • Reference standards for academic and regulatory laboratory studies

    2. Reference Chemical for Laboratory Analytical Standards

    Certified laboratories and reference material producers require high-purity phenformin hydrochloride as a calibration chemical and positive control for analytical methods, such as HPLC and LC-MS, especially in settings involved in drug residue screening, forensic toxicology, and method validation for pharmacological research. Our strict lot release protocols ensure traceability, identity, and purity for these demanding applications.

    Industry compliance standards

    • ISO/IEC 17025 accreditation for testing laboratories
    • ISO 17034 for reference material producers
    • ICH Q6A (Specifications: Test Procedures and Acceptance Criteria for New Drug Substances)
    • USP reference standard certification protocol

    Typical usage ratio

    • Used at 0.01%–1% solution concentrations when preparing calibration curves and control spikes, with working levels set according to instrument response factor requirements and analytical method validation SOPs.

    Downstream process integration

    • Dissolved and diluted for analytical sample preparation, spiked into matrix blanks or assay solutions, and processed through validated reference material bottling and labeling prior to dispatch to end users.

    Final product types

    • Pharmaceutical HPLC/LC-MS reference standards (for QC and research)
    • Certified analytical control kits for laboratory accreditation
    • Calibration reagents for regulatory toxicology testing
    • Secondary standards for academic and commercial research laboratories

    3. Synthesis of Specialty Reagent Salts for Diagnostic Research

    Producers of specialty biochemical reagents use phenformin hydrochloride as a core precursor for synthesizing reagent grade salts, which serve as selective inhibitors and comparison agents in metabolic or mitochondrial function diagnostic test kits used in academic and industry research. These salt preparations undergo rigorous purification and batch-to-batch certification before integration into standardized research assay products.

    Industry compliance standards

    • ISO 9001:2015 (Quality Management Systems for Production of Analytical Reagents)
    • OECD GLP (Good Laboratory Practice) guidelines for non-clinical laboratory safety studies
    • IUPAC recommendations for chemical identity and traceability
    • REACH registration for specialty reagent manufacture (Europe)

    Typical usage ratio

    • Incorporated at 0.1%–10% by mass during secondary reagent salt synthesis, with the amount tailored to match the diagnostic kit’s intended inhibitory concentration specifications.

    Downstream process integration

    • Added during controlled synthetic steps for formation of specialty reagent salts, followed by solvent removal and characterization before blending into assay formulation workstreams.

    Final product types

    • Metabolic enzyme inhibitor standards for basic research
    • Mitochondrial function assay kits (for preclinical laboratory use)
    • High-purity research grade phenformin derivatives
    • Biochemical control compounds for cell biology applications

    4. Chemical Synthesis Intermediate for Structural Analogue Development

    Medicinal chemistry laboratories and pilot plants utilize phenformin hydrochloride as a functional intermediate for structure-activity relationship (SAR) studies focused on biguanide analog development. Here, chemists employ it as a well-defined starting material in substitution reactions, facilitating the preparation of proprietary analogs for early-stage pharmacology screening or intellectual property exploration. Full batch traceability and custom packaging ensure minimal risk of cross-contamination and compliance with research restrictions.

    Industry compliance standards

    • ISO 9001:2015 (Development and manufacture of fine chemicals)
    • IUPAC nomenclature compliance for reporting novel compounds
    • GLP-based research safety and material handling requirements
    • Material transfer agreement (MTA) guidelines for research intermediates

    Typical usage ratio

    • Used at 5%–40% stoichiometric equivalent in SAR reaction vessels, with concentration dependent on the target structural modifications and downstream yield optimization criteria.

    Downstream process integration

    • Entered during primary or secondary amination steps, followed by derivatization or salt-exchange reactions as dictated by synthetic route design for structural analog production.

    Final product types

    • Library compounds for drug discovery programs
    • Biguanide analogs for preclinical screening
    • Reference compounds for patent claims or SAR profiling
    • Custom intermediates for licensed synthesis operations
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    Certification & Compliance
    More Introduction

    Phenformin Hydrochloride: A Manufacturer’s Perspective on Quality, Application, and Distinction

    Shaping a Trusted Chemical: From Raw Ingredient to Finished Product

    Walking along the production line, the atmosphere always holds the subtle, almost sterile tang of active pharmaceutical ingredients mingling in the air. Phenformin Hydrochloride represents a legacy compound; from the weighing of raw materials through each reaction vessel, we commit to a standard forged by science and sharpened by years of operational diligence. We don’t just check boxes for compliance—we live and breathe process control, batch integrity, and end-user trust. Phenformin Hydrochloride, with molecular formula C10H15ClN2, holds a precise, crystalline profile. It is not a casual molecule: its structure demands a careful eye in synthesis, particularly because impurities at even a fraction of a percent reveal themselves rapidly in both lab tests and, more importantly, in performance outcomes for researchers and developers.

    During production, every critical step, from dimethylation to nitrile hydrolysis to final hydrochloride salt formation, occurs under tightly regulated temperature, vacuum, and pH conditions. This isn’t processing—it’s a choreography. We track yield ratios, monitor particulate filtration, and test for residual solvents using validated HPLC and GC protocols. Only lots meeting a strict assay—material often tops 99.5% purity—move to packaging.

    Why Experience in Phenformin Hydrochloride Manufacturing Matters

    Many have witnessed, especially in the last decade, a rush to market for API-grade materials. Speed and margin drive decisions in some factories; we take the opposite approach. There’s no shortcut for legacy knowledge: our handling of solvents, reactivity risk, and product stabilization mean our teams catch anomalies before they appear in the final chemist’s report. We train for scenarios—a spot of off-color, a subtle texture variance—by passing down hands-on knowledge in every shift change, rather than relying solely on digital process logs. As a result, we consistently deliver Phenformin Hydrochloride that passes not only pharmacopoeial standards, but also end-user validation beyond the standard COA printout.

    Another chemist might view batch consistency as just one checkbox in the Quality Assurance outline, but supply interruptions and trends like counterfeit intermediates harm the scientific ecosystem. Decades of experience let us recognize the difference between a minor anomaly and one that demands a halt and rerun—the sort of call that only comes with a deep working relationship at each stage of reaction and finished product inspection.

    Specifying Phenformin Hydrochloride: What Model and Purity Bring to Projects

    Our model of Phenformin Hydrochloride focuses on a specification most researchers and formulators call “pharmaceutical grade,” with each lot characterized by tight limits for lead, arsenic, and residual solvents. The melting point holds between 175-177°C; water content measures under 0.5% by Karl Fischer analysis. The crystalline habit is tightly controlled—not all batches look identical, but each aligns with strong compaction and low friability needed for further formulation work. High purity sits above 99% by HPLC, and bulk density stays in a repeatable range, facilitating accurate measurement and minimal dust loss.

    We track particle size distribution for every lot, as even marginally larger or finer particles can influence how researchers incorporate the compound into both solution and solid dosage platforms. Rather than leaving specifications broad, we dig deeper into subvisible particulate levels to guard downstream processes. It’s not about piling up certificates; it’s about avoiding headaches in blending, resolving, tableting, or testing.

    End Use: Where Phenformin Hydrochloride Delivers Value

    Our product largely supplies professional R&D efforts. Phenformin Hydrochloride attracts researchers focused on metabolic pathways, glucose management, and mitochondrial mechanisms. It has historically drawn attention as a biguanide hypoglycemic agent—utilized extensively before the rise of newer analogues. In today’s research labs, projects often center around treatment modeling, metabolic stress response, or complex interaction studies. The purity, absence of long-chain impurities, and solvent residues become more than talking points—they set the baseline for reproducible results.

    Sourcing matters, especially as many laboratories demand water content control and batch-to-batch standardization over large research programs. As manufacturers, we lean into this by maintaining archived retention samples—so any deviation a researcher detects, we can compare rapidly, helping them keep their projects on schedule and on budget.

    Distinguishing Genuine Material from Market Variability

    Everyone in chemical manufacturing eventually encounters those moments when a customer mentions subpar experiences from another source: odd odors, excess moisture, blurred assay results. What stands out for Phenformin Hydrochloride is how sensitive researchers have become to such inconsistencies due to the rise in imitation and poorly handled intermediates. We build product identity by focusing on traceability—tracking every ingredient from arrival through storage, synthesis, purification, and packaging, all under the same roof. Documentation is not an afterthought. Each sealed container carries batch lineage that backs up any future inquiry.

    Market fluctuations produce more than price swings. They foster corners cut, with upcycled or “reclaimed” reagents entering the chain. We reject any material not meeting our DOC (Declaration of Compliance) standards. Over time, this fosters a relationship not dependent solely on pricing, but on reliability, transparency, and predictable performance. Research operations seldom tolerate unexpected delays from an out-of-spec batch, so our own direct manufacturing gives end-users a level of certainty that third-party “handlers” or brokers simply can’t offer.

    Comparison with Similar Compounds: Learning from Metformin and Other Analogs

    The biguanide family naturally invites comparison—Metformin is the most recognized among hypoglycemic drugs. Though Metformin continues to hold market share in the clinic, research communities return to Phenformin for its distinct pharmacokinetic and mechanistic properties. Structurally, Phenformin introduces a phenylethyl group, making it more lipophilic and thus alters its biological half-life and cell penetration properties.

    In practice, this means researchers select Phenformin Hydrochloride for its more pronounced mitochondrial inhibition profile. This creates a clear division in research use-cases—Metformin for broad, milder metabolic studies, Phenformin when projects move toward aggressive modeling of mitochondrial stress or glucose suppression. Our production lines recognize this distinction and avoid cross-contact between different biguanides to preserve sample purity and exclude contamination concerns.

    Commitment to Scientific Advancement and Sustainable Operations

    Sustainability means more than a tagline in our facility. Waste minimization, solvent recovery, and risk management plans actively shape production runs. Each campaign begins with raw material stewardship—not just for regulatory compliance, but to ensure a long-term, self-replenishing feedstock. Every liter of process water recycled or every drum of solvent recovered translates into lower emissions and less waste removal downstream. We employ closed-loop filtration units and air scrubbing systems within the plant, not simply reacting to local policy but leading with practice.

    Several partners have visited over the years to review process controls, always interested in how proprietary tweaks, such as modified reflux condenser design or new catalyst selections, have cut both byproduct formation and energy demands. Constant observation, frequent site audits, and transparent sharing of process yields with R&D partners keep us on a progressive track—updating methods not for short-term gain, but to build a stronger foundation for years to come.

    Supporting Customers Beyond the Product

    Order fulfillment carries responsibilities beyond getting a drum out the door. Beyond everyday documentation, we maintain long-term technical support, sample retention for disputed batches, and product knowledge sharing. When a research group faces assay drift or solubilization difficulty, our internal teams commit lab hours to collaborative troubleshooting. We’re not just sending a box; we’re invested in the outcome of the lab project or formulation line. If a regulatory body signals a change in compliance or allowable residues, we act early, offering guidance and—if needed—new documentation or revised product for ongoing trials.

    Our technical staff connect directly with researchers, fielding questions about everything from buffer solutions to compatibility with analytical standards. Learning from those conversations, we adapt batch management, retainers, and technical data sheets to speak not only to today’s requirements but also to prepare for regulatory shifts or next-generation research needs.

    Challenges and Solutions Moving Forward

    No supply chain ever stands still long enough for anyone to get comfortable. Shipping conditions, political changes, and regulatory frameworks alter the landscape monthly. Phenformin Hydrochloride, though mature as a molecule, feels these pressures acutely—especially because the margin for error in therapeutic research blurs between an acceptable result and a failed project. Every year, stories circulate of contaminated shipments or incoming lots that throw off months of work.

    We protect our customers’ investments by managing end-to-end logistics in-house. Each shipment includes temperature data logging, tamper-proof seals, and a chain-of-custody maintained by company staff—outsourcing increases the risk and breaks accountability. Alongside physical controls, our documentation infrastructure remains robust; every COA, MSDS, stability data package, and impurity profile follows the lot until project closeout. Such traceability doesn’t offer only compliance benefits—it builds the trust that undergirds scientific advancement.

    Creating Long-Term Value: Beyond Commodity Thinking

    There’s a tendency across the chemical sector to see older molecules as “solved” or as commodities. Phenformin Hydrochloride resists this view by rewarding those who deliver well-controlled, fully traceable material—because demand pivots not on volume but on performance in specialized R&D and testing environments. Many partnerships began with a small sample lot sent to a lab in need of reproducible glucose suppression behavior, and over time these partnerships grew into multi-year collaborations anchored by joint problem-solving and mutual respect.

    The long-term relationships forged by doing things the right way—rather than the fastest or cheapest—yield dividends in word-of-mouth, repeat projects, and technical progress. Quality investments return value for everyone in the chain, placing well-characterized, reliable Phenformin Hydrochloride into the hands of people making tomorrow’s discoveries.

    Conclusion: Direct Manufacturing as Assurance and Partnership

    Few products challenge or reward a chemical manufacturer like Phenformin Hydrochloride. There is satisfaction—and responsibility—in knowing that each batch not only leaves our facility with full traceability but also reaches a lab with the reliability and consistency required by advanced research. From synthesis optimization to rigorous quality checks to client collaboration, our perspective comes not from distant distribution chains or speculative procurement, but the lived experience of making, testing, and standing behind the chemical itself.

    The work never really ends. As regulations evolve and researchers pursue deeper insights into metabolic pathways, we remain committed—not only to batch integrity, but also to seeing our partners succeed. By embedding transparency, technical rigor, and responsive support in every shipment, we provide more than just a chemical; we offer a partnership built on confidence, care, and lasting scientific value.