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4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol

    • Product Name 4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol
    • Alias Osimertinib
    • Einecs 684492-24-6
    • 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

    343417

    Chemical Name 4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol
    Molecular Formula C17H20FN3O3S
    Molecular Weight 365.43 g/mol
    Cas Number 2224337-83-9
    Appearance White to off-white solid
    Solubility Soluble in DMSO, methanol
    Purity Typically >98%
    Storage Conditions Store at 2-8°C, dry place
    Synonyms No common synonyms documented
    Smiles CC(C)C1=NC(=C(C(=N1)N(C)S(=O)(=O)C)CO)C2=CC=C(C=C2)F
    Inchi InChI=1S/C17H20FN3O3S/c1-11(2)16-20-14(10-22)17(21(3)25(4,23)24)19-15(16)12-5-7-13(18)8-6-12/h5-8,10-11,22H,9H2,1-4H3

    As an accredited 4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing The chemical is supplied in a 10g amber glass vial with a secure screw cap, labeled with chemical name, formula, and hazard warnings.
    Shipping The chemical 4-(4-Fluorophenyl)-6-isopropyl-2-[(N-methyl-N-methylsulfonyl)amino]pyrimidine-5-yl-methanol should be shipped in airtight, clearly labeled containers, compliant with relevant hazardous materials regulations. Ship at ambient temperature unless specified otherwise, preventing exposure to moisture, light, or extreme conditions. Include safety data sheets and ensure all packaging meets chemical transport laws and international shipping standards.
    Storage Store **4-(4-Fluorophenyl)-6-isopropyl-2-[(N-methyl-N-methylsulfonyl)amino]pyrimidine-5-yl-methanol** in a tightly sealed container, in a cool, dry, well-ventilated area, away from direct sunlight, heat sources, and incompatible substances such as strong oxidizers. Avoid humidity and moisture. Label the container clearly, and handle under local exhaust or chemical fume hood. Use appropriate personal protective equipment when handling.
    Application of 4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol

    Applications of 4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol in Industrial Manufacturing

    As a direct manufacturer, we supply 4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol primarily to the pharmaceutical sector and other highly regulated downstream industries. This advanced pyrimidine derivative supports stringent industrial production demands as a key functional intermediate. Below we detail its authentic end-use application areas, reflecting real industrial practice, compliance requirements, formulation usage ranges, integration in customer process flows, and the actual categories of finished goods produced by OEMs and CMO partners.

    1. Antihypertensive Drug Intermediate Manufacturing

    This compound serves as a critical building block in the production of certain antihypertensive agents within the ARB (angiotensin II receptor blocker) class. Our partners apply this intermediate in multi-step organic syntheses, forming the backbone of high-purity APIs that meet global pharmacopoeia criteria for finished drug substances. Material grades and specification consistency are maintained to ensure batch reproducibility and downstream regulatory acceptance.

    Industry compliance standards

    • ICH Q7 Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients
    • Pharmacopoeia monographs: USP, Ph. Eur., JP as applicable to API target molecules
    • 21 CFR Part 211 (US FDA cGMP for finished pharmaceuticals)
    • Regulatory requirements per EMA, MFDS, and CFDA for ARB intermediates

    Typical usage ratio

    • 1.0–1.2 molar equivalents relative to next-step nucleophilic reactants, adjusted according to process yield and impurity profile management

    Downstream process integration

    • Introduced after initial aromatic substitution, generally at Stage 3–5 in the API synthesis route
    • Reacts under controlled temperature with protected amines and heterocyclic moieties in anhydrous environments
    • Purification through repeated crystallization and HPLC as adopted in pharmaceutical intermediate plants

    Final product types

    • Active Pharmaceutical Ingredients (APIs) for antihypertensive finished dosage forms (tablets, capsules)
    • Bulk intermediates for licensed ARB medications
    • Clinical trial batches for pharmaceutical R&D pipelines in cardiovascular medicine development

    2. Process Intermediate for Sartan Family Drug Substance Synthesis

    Major pharmaceutical companies use this molecule within the synthetic schema of sartan drugs to introduce specific fluorinated aryl and isopropyl-pyrimidine motifs. Controlled addition ensures targeted chemical transformation, with analytical verification of structural integrity and consistent impurity levels. Supply documentation includes validation packages supporting regulatory submissions.

    Industry compliance standards

    • EU Directive 2001/83/EC: Standards for Medicinal Product Ingredients
    • ChP 2025 Edition (Chinese Pharmacopoeia API intermediate quality chapter)
    • USP Chapter <661> and relevant EMA API monograph standards
    • WHO Technical Report Series: Good Manufacturing Practices for pharmaceutical starting materials

    Typical usage ratio

    • 0.8–1.5 molar equivalents based on final scale, adjusted to minimize residual solvent and maximize conversion efficiency

    Downstream process integration

    • Acts as a coupling agent post-pyrimidine ring assembly during microwave- or batch-reactor mediated condensation
    • Deployed in the penultimate step prior to API neutralization and salt formation
    • Participates in in-process controls using NMR and LC-MS monitoring for structure confirmation

    Final product types

    • Bulk API lots for antihypertensive sartan drugs (e.g., irbesartan, candesartan)
    • Reference standards for regulatory analytical chemistry laboratories
    • Pharmaceutical technical grade intermediates for branded and generic drug manufacturing

    3. Reference Compound in Pharmaceutical R&D and Analytical Standards Labs

    Specialty research and analytical divisions within pharma companies purchase this molecule as a qualified reference substance for method development, impurity profiling, and forced degradation studies. High-purity characterization meets internal QC and external regulatory requirements for new impurity studies and batch release evaluation protocols. Each shipment provides detailed certificates and spectroscopic data.

    Industry compliance standards

    • ISO 17034: Competence of Reference Material Producers
    • Ph. Eur. General Chapter 5.12: Qualification of Reference Standards
    • USP <857> & <858>: Reference Standard and Analytical Instrument Qualification
    • ICH Q3A(R2)/Q3B(R2): Impurity control in new chemical entities

    Typical usage ratio

    • 10–50 mg per analytical batch, individually weighed and tested for each instrument calibration or method validation; actual amount based on assay sensitivity and batch size

    Downstream process integration

    • Used during development of UPLC, LC-MS/MS, or HPLC analytical protocols for identification and quantification of related substances
    • Applied in stability-indicating method validation, impurity threshold studies, and QC batch release tests
    • Participates as an internal or external standard in pharmacological research studies and preclinical API characterization

    Final product types

    • Validated reference substances for pharmaceutical research and quality laboratories
    • Certified analytical standards for impurity tracking
    • Documentation packages for method validation regulatory submissions

    4. Specialized Intermediate in High Purity Custom Synthesis

    Custom synthesis contractors order this compound to manufacture advanced intermediates and reference substances for highly specific pharmaceutical R&D targets. Accurate specification and reproducible impurity removal remain primary requirements to ensure compatibility with downstream sensitive coupling reactions. Detailed supply chain traceability and documentation enable direct use in regulatory submissions and scale-up operations.

    Industry compliance standards

    • ISO 9001:2015 Quality Management Systems for chemical production
    • OECD GLP Guidance for test article manufacture in regulated studies
    • US Pharmacopeia and relevant CMC documentation for investigational drug intermediates
    • Controlled documentation for ICH Q11 (Development and Manufacture of Drug Substances)

    Typical usage ratio

    • 0.2–1.0 molar equivalents depending on the complexity of target molecule synthesis, with adjustment based on reaction pathway optimization and downstream purification strategy

    Downstream process integration

    • Supplied for use in stepwise or convergent organic pathway design by medicinal chemistry teams
    • Added as a core fragment in coupling or derivatization reactions forming patent-protected APIs or analogs
    • After use, advanced purification via preparative chromatography or crystallization optimizes for subsequent synthetic steps

    Final product types

    • Specialty high-purity intermediates for investigational pharmaceutical compounds
    • Preclinical material for safety and efficacy studies
    • Patent-eligible molecular entities submitted for regulatory registration
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    Certification & Compliance
    More Introduction

    4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol: From Process to Application

    A Manufacturer’s Perspective on Innovation and Responsibility

    Manufacturing chemicals that land at the core of pharmaceuticals and agrochemical research shapes the way we approach both process and purpose. 4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol developed here does not merely rely on textbook approaches or third-party standards; it stems from hands-on experience with project-driven chemistry. Our journey with this compound met challenges that some overlook—from the purity embedded in every batch to the traceability of intermediates. The route we use starts from carefully selected starting materials, not only for cost or yield, but for consistent performance and a footprint that aligns with regulatory and safety goals.

    Our Process: Precision Over Shortcuts

    Every synthetic route we deploy at our manufacturing site gets tuned after trial, error, and the kind of pilot feedback that comes only from full-scale production. Our chemists found that controlling the sulfonylation step, managing humidity, and testing for side products mark the dividing line between a trustworthy product and a gamble with someone’s downstream process. With this molecule, side reactions can disrupt both safety and yield. The N-methyl-N-methylsulfonyl protection often causes overalkylation if not managed at the right temperature and under the right solvent systems. Sticking to solvent specifications and temperature ramps lets us give out product whose batch histories are clear—not just on the certificate, but in actual lab and in-process records.

    Structural Detail Drives Application

    Chemists designing kinase inhibitors, anti-inflammatory agents, or candidates in metabolic research trace each substituent for both activity and tolerability. Placing a fluorine atom at the para-position on the phenyl ring shifts electron distribution, contributing to both metabolic stability and interaction with biological targets. A lot of carbons have rotated through our columns, yet fluorine’s impact—on logP, binding affinity, or simply on avoiding oxidative metabolism—deserves more attention in this product than it would in a simple aromatic. The isopropyl group tucked into the pyrimidine framework changes not just steric environment but also solubility in mixed solvent systems researchers typically work with.

    The challenge comes when a sulfonyl group like N-methyl-N-methylsulfonyl gets introduced. Not only does it influence biological data, but it changes the entire handling profile in manufacturing—sensitivity to base, modifications in crystallization (often lowering yield or purity if rushed), and a different cleaning sequence for reactors. Failing to address this can lead to cross-contamination or fouling, ultimately impacting downstream users in their own synthesis steps.

    What Specifications Mean in the Real World

    Specs make or break production. Lab-scale purity says little about the challenges in full-kilogram scale—trace water content, particle size for easy weighing and transfer, and resistance to decomposition over warehouse storage periods. Anyone offering this compound just based on nominal HPLC or NMR results overlooks the needs of those who rely on actual measured stability in a shipment as it sits weeks in logistics. We record water content below 0.2% w/w before packaging at the warehouse. Each drum carries data on the actual homogeneity measured post-milling—such handling reduces clumping and guarantees downstream weighing matches the specs.

    While generic specs—98% or higher purity—may sound adequate, project chemists know that side products like residual mesyl chloride or fluorinated byproducts can disrupt biological assays or create noise in subsequent reactions. Our batches undergo targeted tests not just for global purity, but for specific impurities identifiable by their own retention times and spectral fingerprints. Years in manufacturing tell us that documentation of these trace contents guides our partners in both risk assessment and regulatory submissions.

    How This Product Differs from Others on the Market

    The market has seen a rush of pyrimidine analogs, yet bulk offerings often overlook process origins. A copycat compound made in an open reactor or rushed by untrained staff may meet nominal purity, but trace contaminants—unnoticed until a reaction fails at the customer’s site—become the silent saboteurs. Our process sets this compound apart for three reasons: traceability, reproducible isolation, and predictable storage behavior.

    First, we track every incoming raw material from supplier verifications, and maintain full in-lab records for every batch synthesis, even down to the source of the solvent and the lot numbers of each additive. This is not bureaucratic red tape, but a hard-earned lesson from pressure to respond quickly to quality deviations—something a generic producer cannot claim without robust internal systems.

    Second, our process does not treat the end user’s downstream fate as an afterthought. Crystallization is tuned not just for yield but also for manageable particle size—customers in medicinal chemistry or pilot manufacturing want compounds that suspend, dissolve, and process without bottlenecks. We format our product as a free-flowing off-white powder, tested for both bulk density and transferability, lowering operator risk and allowing more reliable dosing.

    Third, storage matters. Pyrimidines carrying sulfonyl substitutions tend to form hydrates or pick up atmospheric moisture. We validate and document desiccant-pack and vapor-barrier strategies with actual time-resolved stability studies, not simply with theoretical shelf-life based on literature. Years of storage and warehouse experience, along with customer reports, make us adapt our protocols for packaging—double-sealed drums, batch-dated and tracked through transit.

    Usage: What We See in Customer Projects

    Scientists order this compound for several modern pharmaceutical goals, not limited to research but extending to pilot campaigns and even early process optimization for manufacturing. Medicinal chemistry groups call for small amounts, often requesting documentation of water content and detailed impurity profiles to reduce risk during SAR studies. Several step-optimizations use our product for its ready conversion into kinase inhibitors and as an intermediate in building block cascades.

    Custom synthesis teams request kilogram lots for scale-up batches, which opens up unique requirements: batch-to-batch reproducibility, robust handling under process conditions (such as heating or exposure to strong base during coupling reactions), and confirmation that trace residuals do not build up in their reactors. Some partners even audit our facilities, focusing on how solvent residues and material transfer practices reduce unpredictability.

    Outside pharmaceuticals, research in crop science looks for variations in substitution patterns on the pyrimidine core. These customers often subject our compound to further halogenation, cross-coupling, or even direct conversion to ureas or amides for bioactivity screens. They report that consistency in melting profile and absence of color contamination strongly affect downstream reaction choices and yields.

    Comparing to Alternative Suppliers and Analog Compounds

    Other producers sometimes take shortcuts—open-air reactions, questionable use of recycled solvents, or incomplete records on prior batch histories. As a manufacturer who has traced reactor fouling and batch failures all the way back to cheap, uncontrolled processes, I can tell you why traceable origin and batch-specific control make a genuine difference. Every kilogram that leaves our plant carries a paper and data trail—from the pressure controls during sulfonylation to the analytics demonstrating conforming to impurity cutoffs.

    Analogous compounds, perhaps with a methyl, ethyl, or another halogen in the place of a fluorine or isopropyl, may look similar in theory, but performance data tell a more nuanced story. The interplay of electronic environment and steric hindrance in this particular compound determines more than downstream patent strategy—it shapes processability, solubility, and even shelf-life. Chemists who have worked with multiple variants report—which our own application support can confirm—that fluorine in the para position often gives better results in stability assays and enables both faster and cleaner modifications downstream.

    The Challenge of Delivering Quality Consistently

    Sustaining high quality batch after batch takes more than protocols on paper. It takes technician skill, regular training, and a culture that discourages shortcuts. We run batch-to-batch testing using sample retention, not to fulfill a tick-box exercise, but to answer the barrage of troubleshooting questions that real projects demand. If a customer hits a snag in downstream oxidation, we check not just their batch specs but go back with samples pulled from our own storage—sometimes months old—to rule out drift in storage or handling.

    Equipment maintenance, calibration of balances, temperature controls during critical reaction points—these shape product integrity more deeply than the certificate that travels with a drum. Projects come in that ask about trace levels of specific byproducts, and we can cut through speculation because our staff log every deviation and anomaly.

    Meeting Regulatory and Transparency Demands

    Many of our partners pursue regulatory filings, so transparency and trace substance tracking shape not just their comfort level but their business prospects. We have spent years building up the documentation, process logs, and analytical capacity that let us answer regulatory product-quality requests promptly. Chromatographic and spectral data archived for every lot let us back up claims if ever a question comes from a reviewer.

    Our team interacts with auditors and consultant scientists directly. They investigate records on raw material lots, ask about rinse protocols between batches, and require details about batch segregation—something that matters if the compound shares a reactor with other sulfonylated or halogenated products. These audits, sometimes stressful, refine our processes for all clients, not just the one in the spotlight.

    Safety Through Experience

    The chemical’s functional groups require care, especially with sulfonyl fragments—the mesyl portion reacts differently with base and heating than standard methylated amines. We have scaled up emergency response plans not because the compound needs it most of the time, but because experience pushes preparation. Training on spills or fire response, even reactor quenching protocols, comes from lessons taught by low-probability, high-impact scenarios. Our operators benefit from drills and actual procedural changes after every near miss.

    Customers know that documentation and labeling matter, but they also appreciate data on actual process hazards and operator exposure. We document our own experience with ventilation, PPE requirement upgrades, and real feedback from the people who weigh, charge, and sample the compound daily. This practical feedback enriches not just our own protocols, but also the support we offer to anyone working with this compound further downstream.

    The Future of Specialty Pyrimidines: Scaling and Adaptation

    As demand surges, scale-up brings both reward and risk. We built flexibility into our plant to expand production of this compound for bulk loads, and that meant significant investment in larger reactors, dust containment, and automated material transfer. These investments let us handle kilogram and multi-kilogram orders without skimping on traceability or user safety.

    Experience shows that customer needs do not stand still. Some require compound formatted for high-throughput screening—a powder that dispenses with minimal static; others ask for low-dust granules for automated solid handling. We learn from each project and adapt process conditions, drying times, and packaging steps to minimize operator error and maximize product usability.

    Why Direct Manufacturing Experience Matters

    Having produced and shipped thousands of kilograms of intermediates and specialty heterocycles, I can attest that hands-on manufacturing beats any theoretical checklist. Each failure led to a change, every success created a new standard. Bringing 4-(4-Fluorophenyl)-6-Isopropyl-2-[(N-Methyl-N-Methylsulfonyl)Amino]Pyrimidine-5-Yl-Methanol to market means more than ticking off regulatory boxes—it means building a product and a process as robust as the research and manufacturing ambitions it supports. The experiences, the hands stained by process solvents, and the stories from pilot lines shape a product that stands up not just in tests, but in real world downstream use.