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N-Acetyl-L-Isoleucine

    • Product Name N-Acetyl-L-Isoleucine
    • Alias Acetylisoleucine
    • Einecs 249-914-9
    • 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

    954543

    Chemical Name N-Acetyl-L-Isoleucine
    Molecular Formula C8H15NO3
    Molar Mass 173.21 g/mol
    Appearance White to off-white powder
    Solubility Soluble in water
    Melting Point 157-160°C
    Cas Number 4036-93-1
    Optical Rotation [α]20/D +16 to +19° (c=1, H2O)
    Storage Temperature 2-8°C
    Purity Typically ≥98%

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

    Packing & Storage
    Packing White, sealed plastic bottle containing 100 grams of N-Acetyl-L-Isoleucine, labeled with product details, hazard symbols, and batch information.
    Shipping N-Acetyl-L-Isoleucine is shipped in tightly sealed containers to protect it from moisture and contamination. It is typically transported at ambient temperature unless otherwise specified. Packaging complies with chemical safety regulations, ensuring secure handling during transit. All shipments are clearly labeled with appropriate hazard warnings and accompanied by relevant safety documentation.
    Storage N-Acetyl-L-Isoleucine should be stored in a tightly sealed container, away from light, heat, and moisture. Store at room temperature (15–25°C) in a dry, well-ventilated area. Keep away from incompatible substances, such as strong oxidizers. Ensure the storage area is clearly labeled and follow all safety guidelines to prevent contamination or accidental exposure.
    Application of N-Acetyl-L-Isoleucine

    Applications of N-Acetyl-L-Isoleucine in Industrial Manufacturing

    N-Acetyl-L-Isoleucine serves specialized roles across various industrial value chains, with precise functions in pharmaceutical, nutraceutical, infusion solution, and peptide synthesis sectors. Its high purity, defined chiral structure, and favorable stability contribute to its practical adoption in formulations requiring controlled-release profiles, enhanced solubility, and chemical uniformity. Below, we detail distinct downstream application scenarios grounded in actual market practices, demonstrating its integration in modern manufacturing workflows.

    1. Pharmaceutical Intermediate for Neuroprotective APIs

    Leading pharmaceutical manufacturers employ this material as a core intermediate in the synthesis of active pharmaceutical ingredients (APIs) for neuroprotective drug products targeting rare neurometabolic disorders. Its acetylated moiety provides a chemical building block for controlled molecular modification, ensuring reproducible pharmacological activity while meeting stringent impurity controls. Throughout the synthesis pipeline, precise input ratios and strict adherence to industry protocol enable reliable batch processing from intermediate stage to API isolation.

    Industry compliance standards

    • ICH Q7 GMP for Active Pharmaceutical Ingredients
    • EU Guidelines for Good Manufacturing Practice (EudraLex Volume 4)
    • USP/NF monographs for amino acid derivatives
    • FDA 21 CFR Part 210 & 211 for finished pharmaceuticals

    Typical usage ratio

    • 3–8% molar basis, adjusted based on stoichiometric requirements for specific API synthesis pathways
    • Input quantities fine-tuned through pilot-scale validation and impurity profiling

    Downstream process integration

    • Added during the early-stage condensation or amidation reactions in multi-step chemical synthesis lines
    • Undergoes purification via crystallization or preparative chromatography before further downstream transformation

    Final product types

    • Orally disintegrating tablets for neurodegenerative diseases
    • Injectable sterile APIs indicated for rare metabolic disorders
    • Oro-mucosal formulations with improved bioavailability profiles

    2. Component in Clinical Nutrition Formulas

    Manufacturers of clinical nutrition blends, including parenteral and enteral products, incorporate the ingredient to diversify essential amino acid profiles, especially in formulas designed for compromised metabolic functions. Its acetylation reduces bitterness and improves solubility, critical for compatible infusion or powdered mixtures. Nutrition scientists tailor the proportion based on metabolic tolerance, ensuring compliance with global clinical nutrition standards and documented amino acid safety data.

    Industry compliance standards

    • Codex Alimentarius Standard for Infant Formula and Adult Nutritionals
    • USP Nutritionals General Chapter & FCC Food Chemicals Codex
    • ISO 22000:2018 Food Safety Management Systems
    • EU Regulation (EU) No 609/2013 on Food Intended for Infants and Special Medical Purposes

    Typical usage ratio

    • 0.02–0.12% w/w in ready-to-drink or reconstituted enteral solutions dependent on patient weight, clinical regime, and amino acid score
    • Range refined by in vitro stability and clinical tolerance studies during product development

    Downstream process integration

    • Hydrated and blended during wet mixing step of liquid formula compounding
    • Dry blended before UHT sterilization and aseptic filling for powdered nutritional products

    Final product types

    • Therapeutic dietary powders for inborn errors of metabolism
    • Medical meal replacement beverages
    • Multicomponent amino acid oral supplements

    3. Precursor for Peptide Synthesis in Biopharmaceuticals

    Chemical peptide manufacturers routinely use acetylated, enantiomerically pure amino acids during solid-phase peptide synthesis (SPPS), especially for producing pharmaceutical-grade oligopeptides with improved resistance to enzymatic degradation. This material enhances the site-specific modification of terminal amino groups, enabling creation of peptides with tailored pharmacokinetics. Its consistent purity levels help minimize side-reactions and facilitate scale-up in automated synthesizers.

    Industry compliance standards

    • ICH Q11 Development and Manufacture of Drug Substances
    • Ph. Eur. and JP quality standards for amino acid building blocks
    • ISO 9001:2015 Quality Management for Active Ingredients
    • FDA QSR 21 CFR Part 820 (when used for combination products)

    Typical usage ratio

    • Varies from 1–4 equivalents per peptide coupling site, based on desired peptide sequence and resin loading factor
    • Strictly monitored via in-process HPLC against sequence impurity thresholds

    Downstream process integration

    • Integrated at N-terminal capping steps within iterative Fmoc/t-Boc SPPS protocols
    • Utilized in protected form, followed by global deprotection and cleavage post-assembly

    Final product types

    • Custom peptide APIs for research and preclinical testing
    • Peptide drugs with N-acetylation motifs
    • Diagnostic and imaging agents requiring stable acetylated peptides

    4. Functional Excipient in Parenteral Infusion Solutions

    Companies producing parenteral infusions add the acetylated amino acid as a stabilizer or osmolality-adjusting excipient in amino acid solutions intended for intravenous nutrition. Application in these settings leverages the improved aqueous solubility and metabolic compatibility of the acetyl derivative compared to regular isoleucine. Formulators optimize inclusion levels to match pharmaceutical sterility and injection safety benchmarks while maintaining electrolyte and amino acid balance for clinical administration.

    Industry compliance standards

    • USP <797> Sterile Compounding Guidelines
    • Japanese Pharmacopoeia: Intravenous Infusion Requirements
    • Pharmacopoeia Europaea (Ph. Eur.) Monographs for Injectable Solutions
    • WHO Model List of Essential Medicines for Parenteral Nutrition

    Typical usage ratio

    • Up to 0.04% w/v, calibrated according to total amino acid concentration and electrolyte formulation
    • Dosage finalized following solution stability and osmolarity validation batches

    Downstream process integration

    • Dissolved in sterile water during primary solution blending in cleanroom environments
    • Filtered through 0.2 μm membranes prior to terminal heat sterilization and fill-finish

    Final product types

    • Amino acid parenteral nutrition bags
    • Specialty intravenous infusions for metabolic support
    • Electrolyte-balanced clinical hydration solutions
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    Certification & Compliance
    More Introduction

    N-Acetyl-L-Isoleucine: Strengths, Features, and Vital Role in Advanced Formulations

    N-Acetyl-L-Isoleucine belongs to a class of amino acid derivatives with unique advantages over standard isoleucine. In production facilities, our technicians work closely with chemists at every stage, assuring precise acetylation using high-purity reagents and stainless-steel reactors to minimize side reactions, consistently hitting high yields. Our batches test clear and nearly colorless, showing excellent solubility in water. This attribute saves time during formulation, avoiding the need for extensive pre-mixing or mechanical assistance, which streamlines both lab and commercial-scale processes and fits rugged production schedules.

    We manufacture N-Acetyl-L-Isoleucine to a stringent purity standard, consistently exceeding 99% by HPLC. Typical batch observations include a melting point in the 180–183°C range, along with very low water content below 0.5%. Controlling particle size is a painstaking process on our floor. We grind each batch to pass through a 60-mesh screen, allowing for reliable distribution whether the user handles pharmaceutical mixing, nutritional fortification, or bioprocess feed.

    Our direct experience with clients in research and clinical sectors shows they value robust batch documentation and traceability for every order. All containers come with full certificates, batch numbers, and links back to original analytical records. Researchers often tell us they look for precise optical purity; our chiral HPLC protocols guarantee L-enantiomer selectivity beyond 99%, which avoids regulatory headaches and uncertain results.

    Why N-Acetyl-L-Isoleucine Draws Attention

    N-Acetyl-L-Isoleucine stands out for several reasons. Many amino acids need stability improvements. Native isoleucine, for example, is more prone to oxidation, poor storage shelf life, and inconsistent dissolution in finished products. The N-acetyl modification alters the amine end to build in both chemical and physical stability. In practice, this lets users store the material longer without detecting hydrolysis or degradation. Production teams often remark on this advantage, especially for applications involving room-temperature warehousing or distribution in tropical climates, where humidity and fluctuating conditions would otherwise degrade less robust analogs.

    Researchers working on neuropathic and metabolic disorders have approached us specifically for N-Acetyl-L-Isoleucine due to its emerging benefits in neuroprotection and metabolic pathway stability. The acetylation increases the molecule’s resistance to enzymatic breakdown. Unlike standard isoleucine, which can be rapidly deaminated in cell cultures or in the bloodstream, the acetylated form resists this catabolism. Formulators see this as a key feature, especially in extended-release or high-dose scenarios. Several research reports have demonstrated longer circulation times compared to unmodified L-isoleucine, which translates directly to better reproducibility in animal studies and less batch-to-batch variation in clinical supply chains.

    Because of its higher stability, N-Acetyl-L-Isoleucine fits easily into complex matrixes. Whether a client is preparing an oral formulation, an injectable vehicle, or a slow-release solid, the physical properties simplify blending steps. Uniform particle size and improved flow reduce bottle necks, as we have seen in customers who previously encountered clumping and settling problems with raw amino acids. Our technical team collaborates on regular troubleshooting calls involving both processing engineers and research chemists, optimizing blends while keeping dust and loss at critical dosage points to the absolute minimum.

    Comparing With Conventional Amino Acids

    Comparing N-Acetyl-L-Isoleucine with conventional amino acids reveals stark contrasts. Clients who first try the acetylated form typically start with concerns over compatibility and final yield, especially in active pharmaceutical ingredient settings. Our records and feedback suggest that N-Acetyl-L-Isoleucine maintains its chemical identity through rigorous granulation, solvent exposure, and milling, while raw isoleucine sometimes decomposes or racemizes under stress. In tableting, we rarely observe capping or lamination, which both cut down on rework and accelerate lot release testing.

    Dietary supplement producers who switched to acetylated versions report smoother taste profiles, reduced hygroscopicity, and easier maskability in multiblend formulas. In one pilot project, a customer eliminated pre-blending steps entirely after converting to N-Acetyl-L-Isoleucine, shaving hours off each production run and reducing their elemental impurity profile by avoiding unnecessary excipients. Our technical records demonstrate that the compound remains non-reactive with standard sweeteners, thickeners, and colorants, eliminating much of the guesswork at scale up.

    From a metabolic perspective, the added acetyl group brings additional bioactivity. While plain L-isoleucine shows good performance in muscle metabolism, N-Acetyl-L-Isoleucine exhibits improved blood-brain permeability, which has drawn the attention of CNS drug developers and metabolic disorder researchers. We’ve supported projects targeting rare inborn errors and neurodegenerative conditions, where standard amino acids underperform or present off-target risks. By controlling both the molecular structure and final batch release, we help clients meet tight regulatory demands for analytical rigor, especially as authorities raise the bar on traceability and impurity thresholds.

    Setting the Standard: In-house Quality Assurance

    Day in and day out, our team oversees small and large-scale runs under ISO-classified cleanrooms. We run every lot of N-Acetyl-L-Isoleucine through a full lineup of tests — from XRPD for crystalline form, FTIR for purity assessment, to thermal gravimetric analysis for stability. Clients know that each drum and pouch can be traced directly back to our reactor logs and QC spreadsheets. By owning our own supply and not relying on third-party traders or brokers, we control every stage from raw precursor to finished compound. This oversight attracts customers fed up with off-spec or variable materials sourced from the open market or subject to unpredictable pricing.

    We do not use recycled solvents or off-grade precursors. All reagents bear pharmaceutical-grade certificates and undergo identity tests before unloading. Storage in climate-controlled warehouses prevents any caking, deliquescence, or oxidation prior to shipment. Analytical chemists consult directly with clients on advanced needs: customized mesh sizes, sterility for injectable feeds, and documentation suites tailored for IND or NDA regulatory filings. Issuing batch records in English and supporting languages ensures clarity for both domestic and overseas clients. Audits are part of our routine operation — external auditors from pharmaceutical and nutraceutical sectors regularly review our compliance.

    We operate validated cleaning cycles for all equipment. As a result, cross-contamination is negligible and all swab samples come back clean from protein residues or acetyl byproducts. This strict attention to detail stems from decades of in-house experience and close consultation with inspection authorities. We know customers cannot risk batch failures due to extraneous residues or contamination, and seamless traceability backs every order.

    Solving Common Challenges in Academic and Industrial Use

    Several issues pushed us to refine our N-Acetyl-L-Isoleucine production. Academic labs frequently struggled with purity fluctuations and inconsistent reactivity from imported material. By moving synthesis and QA in house, we responded with better reproducibility. In dozens of preclinical and process development programs, our product enabled repeatable results and fewer outliers. Pharmacologists reported sharper dose-response curves and reduced analytical noise—an outcome we attribute directly to rigorous process control and hands-on QC.

    Stability failures, a major complaint with raw amino acids, dropped significantly after specification upgrades and handling protocol revisions. Our analytical group found that the acetyl group prevented atmospheric hydrolysis and resisted moisture pickup, important for both powdered and solution phases. Consequently, clients who struggled with caked stock or unexplained degradation curves now see longer shelf lives and sharper analytical signals.

    Our technical support team also works directly with client engineers on scale-up. For industrial users evaluating kilogram to ton-scale batches, process engineers need reliable reactivity and predictable filtration. Our product’s uniform morphology and high solubility address time lost to filter plugging, poor flow, or incomplete recovery. After dozens of scale-up projects, users confirm that our process window lets them hit target concentrations faster and keep yield drift low.

    An Evolving Role in Pharma, Food, and Biotech

    N-Acetyl-L-Isoleucine’s role keeps shifting as research uncovers new therapeutic and nutritional needs. Clinical trial formulators increasingly specify this compound for its handling and regulatory edge. In the neurodegeneration and metabolic disorder research sectors, we’ve witnessed the migration from commodity L-isoleucine to its acetylated cousin. The change grew from both laboratory request and regulatory direction: acetyl modifications meet more rigorous trace thresholds, show fewer side-product peaks, and comply with rising global guidelines.

    In the food and beverage sectors, reformulations use N-Acetyl-L-Isoleucine to improve texture, storage, and phenotypic stability. It resists both chemical and heat breakdown during tough processing cycles — pasteurization, lyophilization, or extrusion extrusion. The clear taste profile enables direct blending into energy products, meal replacements, and high-protein supplements without masking agents or further sweeteners. Where stability and taste once clashed, acetylation bridges the gap.

    For biotechnology firms, the compound supports cell culture performance. Its robustness at room temperature and resilience to atmospheric contamination make it an attractive feedstock for sensitive fermentation and bioprocessing environments. Our customers rely on batch traceability and clean dissolution to support both pilot runs and scale-up, ensuring that data from research batches translate smoothly to production.

    Future Directions and Practical Guidance

    As chemical manufacturers, we keep our focus on process improvements based on actual customer experience and operational feedback. Our R&D team evaluates new analytical techniques, looking for even tighter control over purity and byproduct formation. We invest in cleaner reactor systems, greener solvent recovery, and integrated process monitoring — not because regulations alone demand it, but because every gain in purity and reliability shows up in the hands of formulators and users.

    We work side-by-side with experts from diverse fields — from pharmaceutical development programs to food innovation teams. We share best practices for storage, dispensing, and handling, because stability claims mean little if conditions are not met on site. To reduce waste and risk, we design packaging that holds up to busy warehouse life, seals tightly, and resists tampering.

    Feedback from technologists and production specialists guided us to develop batch sizes suited for both R&D benches and industrial-scale runs. By offering multiple pack options, we let users avoid excess stock and minimize oxidation or loss from repeated opening. Each package’s labeling includes all key analytical data, with QR links to further certificates and support documentation.

    Our on-the-ground experience demonstrates the importance of keeping product quality tied to real laboratory and process outcomes. We regularly invite client teams for on-site quality tours and webinars, breaking down the steps from raw material intake to finished batch shipment. Hands-on training sessions cover safe handling, efficient mixing, and common troubleshooting tactics.

    Ongoing Commitment: A Manufacturer’s Perspective

    Inside our facility, every member of the team knows how small details add up to big differences for clients. Tracking nitrogen purity and monitoring reactor temperature curves help maintain batch consistency, catching even minor deviations before they reach the next stage. Instead of chasing trends, we focus on what delivers—clean, reliable, robust N-Acetyl-L-Isoleucine that works as expected every single time.

    From decades of hands-on experience, we understand that customer trust relies on more than words or ratings. Each return customer, successful R&D run, or clinical milestone feeds a cycle of improvement. Maintaining this reputation draws both seasoned and new formulators who prefer stable, predictable compounds over commodity shortcuts.

    If process upgrades or new regulations present challenges, we adapt through collaborative troubleshooting. Ongoing investment in process validation, analytical expansion, and training anchors our long-term commitment to quality. We see N-Acetyl-L-Isoleucine as more than a line item; it represents a benchmark for how technical dedication and transparency can push an industry forward. Our door remains open for questions, custom requests, and consultation—because real progress comes from experience shared and solutions forged at the source.