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6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride

    • Product Name 6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride
    • Alias Risperidone Impurity C
    • Einecs 681-218-0
    • 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

    639269

    Chemical Name 6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride
    Molecular Formula C12H12FN3O·HCl
    Molecular Weight 269.70 g/mol (free base)
    Appearance White to off-white crystalline powder
    Cas Number 91422-68-3
    Solubility Soluble in water; slightly soluble in organic solvents
    Melting Point 220-224°C (hydrochloride salt)
    Storage Conditions Store at 2-8°C, protected from light and moisture
    Purity ≥98% (varies by supplier)
    Synonyms Risperidone Intermediate; 6-Fluoro-3-(4-piperidinyl)benzo[d]isoxazole hydrochloride
    Pka 3.53 (approximately, piperidine nitrogen)
    Iupac Name 6-fluoro-3-piperidin-4-yl-1,2-benzoxazole hydrochloride
    Usage Pharmaceutical intermediate, mainly for synthesis of antipsychotic drugs

    As an accredited 6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing White, tamper-evident HDPE bottle labeled "6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole HCl," net weight: 25 grams, with safety warnings.
    Shipping 6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride is shipped in tightly sealed, chemically resistant containers, protected from light and moisture. The package complies with regulatory standards for hazardous chemicals, labeled appropriately, and may require temperature control. Shipping documentation includes material safety data and handling instructions to ensure safe, secure, and compliant transportation.
    Storage Store 6-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole hydrochloride in a tightly sealed container, protected from light and moisture. Keep at room temperature (15–25°C) in a cool, dry, and well-ventilated area, away from incompatible substances such as strong acids and bases. Ensure proper chemical labeling and access controls in designated chemical storage areas to maintain safety and stability.
    Application of 6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride

    Applications of 6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride in Industrial Manufacturing

    6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride is a highly specialized intermediate used predominantly in pharmaceutical synthesis, with defined end-use scenarios in antipsychotic active pharmaceutical ingredient (API) production, generic finished dosage manufacturing, reference standard preparation, impurity profiling, and industrial R&D batch synthesis. As a manufacturer, we supply this compound in compliance with rigorous quality requirements, and our production supports global pharmaceutical companies as well as specialized downstream users. Below, we outline key application segments and the exact requirements characterizing each scenario.

    1. Active Pharmaceutical Ingredient (API) Intermediate for Antipsychotic Synthesis

    This chemical acts as a critical intermediate for the synthesis of antipsychotic APIs, where it undergoes transformation as part of the multi-step manufacturing process of specific benzisoxazole-class medications. Our clients directly incorporate it into regulated pharmaceutical syntheses, particularly in steps leading to the formation of risperidone and similar compounds, under strict quality oversight.

    Industry compliance standards

    • Good Manufacturing Practice (GMP) guidelines (ICH Q7 and relevant regional GMPs)
    • U.S. FDA cGMP (21 CFR Parts 210, 211) for API process controls
    • ICH Q3A/B for impurity management in new drug substances
    • European Pharmacopoeia monographs for intermediate stage documentation

    Typical usage ratio

    • Applied at stoichiometric levels as determined by target API synthesis route: typically 1.0–1.2 molar equivalents relative to the key coupling agent; adjustment depends on reaction yield control and batch scale

    Downstream process integration

    • Introduced during the early-to-middle stage of multi-step API synthesis following initial ring construction; processed via controlled coupling, subsequent hydrogenation, and final purification steps before downstream transformation into the final API

    Final product types

    • Active pharmaceutical ingredients including risperidone and licensed generics

    2. Finished Dosage Manufacturing for Solid Oral Forms

    Pharmaceutical manufacturers source this compound as an upstream input to produce finished dosage forms, utilizing it after full conversion to the active species. It is essential in producing the parent API used in solid oral dosage manufacturing, including tablet and capsule formulations, where batch traceability and purity standards are enforced throughout.

    Industry compliance standards

    • WHO GMP and country-specific pharmaceutical cGMP frameworks
    • FDA Guidance for Industry: Process Validation
    • ICH Q6A for finished dosage specifications
    • USP monographs for antipsychotic tablets/capsules (where applicable to finished API derivatives)

    Typical usage ratio

    • Used at converted API yield equivalence; downstream formulation includes 2–6% w/w of active API (derived from this raw material), final ratio determined by strength of the marketed dosage (e.g., 0.5–4 mg/tablet)

    Downstream process integration

    • Enters as a qualified intermediate before conversion to API; after full conversion, included in granulation or direct compression process for tablet or encapsulation lines, with lot validation and in-process analytical control

    Final product types

    • Film-coated tablets
    • Hard gelatin capsules
    • Modified-release oral solids targeting antipsychotic indications

    3. Reference Standard and Analytical Calibration Material

    Specialized laboratories and pharmaceutical quality control units require this material as a traceable standard for analytical method validation and system suitability checks. Accurate reference materials support method specificity and impurity quantification, ensuring regulatory compliance in both development and routine control environments.

    Industry compliance standards

    • ISO/IEC 17025 for laboratory technical competence
    • ICH Q2(R1) Validation of Analytical Procedures
    • Pharmacopoeial requirements for reference standards (USP, EP, JP as applicable)
    • GLP (OECD Principles of Good Laboratory Practice)

    Typical usage ratio

    • Traceable standard solutions prepared at 1–10 μg/mL or as dictated by validated testing protocols for calibration/quantification; exact ratio dependent on sensitivity and LOQ of deployed analytical equipment

    Downstream process integration

    • Prepared as analytical standards for HPLC/UPLC calibration, impurity profiling, and system suitability prior to assay or release testing of API and finished drug batches

    Final product types

    • Pharmacopoeial or in-house reference standards
    • Analytical control kits for pharmaceutical QC laboratories

    4. Research & Development Batch Synthesis in Pharmacological Studies

    Industrial R&D units and contract research organizations utilize this compound in pilot-scale synthesis, allowing for rapid turnaround of pharmacological candidate evaluation. Early process batches require material purity documentation to facilitate the study of synthetic feasibility, metabolic pathways, and analog structure-activity relationships for benzisoxazole-class compounds.

    Industry compliance standards

    • OECD GLP guidelines for non-clinical research studies
    • ICH M3(R2) for non-clinical safety studies
    • Institutional SOPs for R&D quality and traceability
    • GxP-compliant chain of custody for sample handling

    Typical usage ratio

    • Varies widely by study scope: 0.5–5 g/kg of batch material for preclinical experiments, tuned according to synthetic route and yield optimization goals

    Downstream process integration

    • Dosed during initial reaction setup in pilot vessels, often followed by structural modification, impurity isolation, and bioanalytical sample preparation in the research phase

    Final product types

    • Non-GMP small-molecule research compounds
    • Lead compound batches for preclinical screening
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    Certification & Compliance
    More Introduction

    6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride: A Deeper Look Behind the Molecule

    Our Experience as the Manufacturer

    Few intermediates draw as much attention in modern process chemistry as 6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride. We have worked with this molecule for many years, honing our production processes and learning about its critical role in the pharmaceutical landscape. From the earliest steps of synthesis to the care that goes into its final packaging, every stage presents both challenge and opportunity.

    Production involves more than combining precursors and managing reactions. Every batch demands vigilance regarding purity, moisture control, and structural verification. By investing in robust quality systems and in-house analytical capacity, we resolve ambiguities before customers ever see an issue arise. When asked why our material stands out, we point to our real-world attention to these details over time—a focus that distinguishes a committed manufacturer from a sales desk.

    Product Model, Specifications, and Characteristics

    6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride most often appears as a solid, ranging from white to off-white, and offers specific chemical attributes: C12H13FN2O·HCl outlines its molecular structure, while NMR and HPLC trace out its identity and purity. We typically supply this product at a minimum of 99.0% assay by HPLC, with water determined by Karl Fischer and all limits for related substances strictly enforced according to both internal standards and, when required, to current pharmacopeia parameters. Our own analytical lab runs confirmatory identity tests via proton NMR and mass spectrometry—routine for us, essential for our customers.

    During the last few years, customers have pushed for ever tighter impurity control, demanding both achiral and chiral purities with certainty. Our facility hosts a dedicated team who over time have become experts not only in analyzing but also interpreting results, checking for subtle signals that less experienced eyes could miss. Thanks to our own cycle of continual review, the lot-to-lot observability enables downstream manufacturers to plan their syntheses with far greater confidence.

    Functional Impact in Synthesis

    6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride serves as a linchpin in the synthesis of specialty pharmaceuticals, especially those that require the benzisoxazole motif—a framework recognized for its role in central nervous system drug research. Our own collaborations with R&D teams have shown that reliable access to this intermediate helps accelerate timelines; eliminating surprises in purity or reactivity keeps troubleshooting focused on new innovations, not recurring supply headaches.

    Clients frequently share their feedback during method development. Many report that higher residual solvent levels or late-forming degradation products can derail sensitive transformations. We engineer out these particular risks by optimizing crystallization parameters and targeting not just “passable” but surpassing solvent and impurity profiles. Engineers onsite track production constraints, environmental periods, and exact storage conditions, so customers see consistent, reproducible quality.

    Comparative Perspective: What Sets Our Material Apart?

    Some manufacturers focus only on throughput; for us, reliability means doing more than scaling up a tried-and-true synthesis. We refine each production campaign by learning from the previous one. Our technical managers keep close records not just of yields, but also of anomalous runs, analytical captures, and development trials. Out of this cycle arises a wealth of tacit expertise, informing adjustments that translate to lower impurity levels and higher batch-to-batch reproducibility than commonly seen from ad hoc or trader-supplied materials.

    Many competitors circulate material blended from multiple origins, often without direct oversight on upstream chemistry. This approach typically reduces price but clouds traceability and complicates regulatory filings. Since we control all stages—from raw materials through to finished, packed goods—customers receive supporting documentation (CoA, chromatograms, and synthetic route details) that holds up under scrutiny, not just in procurement but under full regulatory review. This approach supports agencies and quality auditors seeking real traceability through the supply chain.

    Usage in Drug Development and Synthesis Workflows

    Every kilo of this intermediate passes through a chain of highly specialized synthetic steps; it is rarely the endpoint but almost always critical to an entire development program. In our work supporting process chemists, we see direct feedback on transformation yields, coupling efficiency, and the ease or difficulty of downstream separations. Minute changes in piperidine purity, fluoro-substituent integrity, or moisture uptake can have consequences down the line, so our batch data includes not only standard certificate values, but also expanded information from our pilot and scale-up records.

    The journey from lab experiment to clinical candidate hinges on both reliability and flexibility. We satisfy requests for small-scale samples, pilot lots, and then multi-kilogram full campaigns, recognizing that each batch may support both toxicology programs and initial clinical material production. Unlike generic intermediates sold without end-use consideration, our production is responsive to customer process changes; we often adjust particle size, filterability, and residual solvent constraints proactively, not on demand. Partners return frequently, not only for the product itself but for the knowledge we share about its behavior in solution, storage, and final application.

    Differences Compared to Similar Compounds

    The structural analogues of this molecule—those lacking a fluoro group, those with other piperidinyl substitutions, or those made with alternate counterions—do not perform identically in advanced pharmaceutical chemistry. Medicinal chemists have demonstrated that substitution at the 6-position introduces changes in pharmacodynamic and metabolic stability profiles. Our product, carrying a high-purity fluoro substituent, undergoes exhaustive verification to rule out positional isomers or regioisomer contamination.

    Changes in the counterion, such as switching from the hydrochloride to another salt, alter both handling characteristics and downstream transformation profiles. For example, the hydrochloride form generally offers superior stability in air, lower hygroscopicity, and improved solubility in specific solvent systems. We document these differences through repeated side-by-side tests using the same equipment and storage protocols, so when a customer queries about alternate forms or specific salt requirements, our responses stem from direct, hands-on experimentation.

    Supporting Data, Documentation, and Compliance

    Our site maintains a comprehensive record of every lot, not just meeting documentation norms but also storing the actual analytical data sets. When authorities or customers require audit support, we produce the original records, spectra, and operational logs used in the making of every batch. It becomes evident that our approach achieves more than passing a test; it demonstrates a philosophy of long-term stewardship for both product and partnership.

    We have adapted operations to meet a spectrum of regulatory expectations. Between regional requirements in Europe, United States, and Asia, no two projects request the same documentation pack. We respond by storing expanded validation protocols and by keeping internal standard operating procedures synchronized with changing international expectations. When production standards or reporting guidelines shift, our internal QA system adopts, tests, and revises before releasing another lot to the market.

    Cost, Logistics, and Supply Considerations

    Logistics remain a perennial concern. Many chemicals are transported in bulk containers or via intermediaries, adding time and uncertain handling to the supply chain. Our team ships from the manufacturing site directly to the intended recipient, using packaging formats optimized for both safety and preservation—not to shortcut but to prevent delays, contamination, or damage. We use both ambient and temperature-controlled freight options, dictated by the final destination’s storage needs and customs protocols.

    Having experienced international supply disruptions and evolving transport regulations, we stock both raw inputs and finished reserves. This buffer allows for prompt fulfillment even under sudden shifts in global chemical logistics. By absorbing some of the risk for our customers, we help downstream partners keep their own projects on course, unaffected by fluctuations in global shipping or regulatory inspection windows.

    Process Optimization and Batch Improvements

    Every campaign brings learning opportunities. The actual conditions—reaction temperatures, pressure, order of addition—carry nuances that seldom appear in literature. Our own chemists hold decades of collective experience. They tweak parameters to enhance yield and selectivity, but they never compromise reproducibility for a marginal gain in output. Troubleshooting does not end after a completed batch; we review every data set and meet as a technical team to discuss outliers, near-miss events, and incremental enhancements.

    Long-term reuse of insights drives steady improvement. For example, our records indicate how adjustments to water content in a precursor feed eliminate detectable levels of certain byproducts. Rather than chasing the maximum theoretical yield, our focus will always be on controlling those variables that matter most—impurity profile, conversion efficiency, and in-process robustness. Each outcome tracks back to the principle that reliability in the product reflects investment in the process.

    Feedback and Continuous Improvement

    Discussions with sourcing specialists, quality managers, and bench chemists shape our priorities. By inviting open feedback, we discover details about reactivity, downstream utility, or shelf-life that pure analytics could never capture. Our technical sales and support staff act as a bridge, collecting information from project managers, API teams, and regulatory specialists, and funneling every useful detail back into our production cycle.

    Several process improvements trace their origins to direct customer comments: tweaks in micronization, packaging reconfiguration, or modification to shipment documentation. We treat every note as an opportunity rather than a disruption. Over time, this two-way exchange deepens confidence—stakeholders begin to see us not as a commodity provider but as a partner committed to scientific and operational transparency.

    Looking Forward: Anticipating Future Demands

    Regulatory oversight, data transparency, and technological advance will continue to reshape expectations for chemical intermediates. As a manufacturer, we plan for these eventualities based on lived experience and careful observation: we keep digital records retrievable and comprehensive, we validate methods to standards above minimal regulatory needs, and we keep a development pipeline ready to adapt synthesis as precursor markets evolve or new impurity controls become warranted.

    Many discussions in our industry focus on price or lead time; both matter, but neither survives poor quality or a failed regulatory audit. Our own evidence, supported by years of customer audits, routine inspection, and real project feedback, reveals that stability in both product quality and documentation underpins sustainable partnership. Chemical synthesis continues to innovate, but the bedrock will always lie in doing the fundamentals right, batch after batch.

    Why Direct Manufacturing Matters

    Over a decade of manufacturing this intermediate has convinced us that there is no substitute for in-house control. Every shipment leaves our facility ready to support emerging therapies and complex research work, and every product reflects the sum total of technical vigilance applied by our own team. The industry demands both transparency and predictability—two qualities that grow out of direct manufacture, not out of paperwork or promises from unseen vendors.

    We see the proof in the workloads of pharmaceutical formulation labs, in the audit trails of regulatory committees, and in the confidence of returning customers. Only a manufacturer with skin in the game and boots on the ground develops that level of expertise and trust, and 6-Fluoro-3-(4-Piperidinyl)-1,2-Benzisoxazole Hydrochloride has proven to be an excellent proving ground for that philosophy.

    Commitment to the Scientific Community

    The applications of this molecule continue to expand. With each new drug candidate or research discovery, the standards shift upward. Our team takes pride in contributing to these advances not just with reliable supply, but with observations, analysis, and open dialogue. For researchers and project managers considering the next step, we offer not only the molecule but a partnership informed by both the triumphs and hurdles of real-world chemical manufacture.

    As the pharmaceutical sector grows both more global and more meticulous, the question turns from who can supply a material, to who will stand behind it throughout its lifecycle—adaptable, transparent, and willing to learn as the science evolves. In that regard, our factory’s record stands open for inspection, and our commitment extends well beyond the boundaries of any one intermediate or campaign.