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

L-Leucine Tert-Butyl Ester Hydrochloride

    • Product Name L-Leucine Tert-Butyl Ester Hydrochloride
    • Alias L-Leucine tert-butyl ester HCl
    • Einecs 603-038-7
    • 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

    365314

    Chemical Name L-Leucine Tert-Butyl Ester Hydrochloride
    Cas Number 53910-67-9
    Molecular Formula C10H22ClNO2
    Molecular Weight 223.74
    Appearance White to off-white crystalline powder
    Solubility Soluble in water and methanol
    Purity Typically ≥98%
    Melting Point 127-131°C
    Storage Conditions Store at 2-8°C, keep in tightly closed container
    Synonyms L-Leucine 1,1-dimethylethyl ester hydrochloride
    Smiles CC(C)C[C@H](NC(=O)OC(C)(C)C)C.Cl
    Iupac Name tert-butyl (2S)-2-amino-4-methylpentanoate hydrochloride

    As an accredited L-Leucine Tert-Butyl Ester Hydrochloride factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing White, crystalline powder is packaged in a 100g amber glass bottle with a secure screw cap, labeled with chemical details and safety warnings.
    Shipping L-Leucine Tert-Butyl Ester Hydrochloride is shipped in tightly sealed containers, protected from moisture and light. It should be transported at ambient temperature unless otherwise specified, complying with standard chemical shipping regulations. Proper labeling and documentation ensure safety and compliance, with handling measures in place to prevent exposure or contamination during transit.
    Storage L-Leucine Tert-Butyl Ester Hydrochloride should be stored in a tightly sealed container, in a cool, dry, and well-ventilated area, away from moisture and incompatible substances. Protect it from direct sunlight and sources of heat. Recommended storage temperature is 2–8 °C (refrigerated). Properly label the container and handle under inert atmosphere if possible to maintain its stability and prevent decomposition.
    Application of L-Leucine Tert-Butyl Ester Hydrochloride

    Applications of L-Leucine Tert-Butyl Ester Hydrochloride in Industrial Manufacturing

    As a direct chemical manufacturer specializing in amino acid derivatives, we supply L-Leucine Tert-Butyl Ester Hydrochloride strictly for advanced chemical synthesis in regulated industrial settings. Below, we present key downstream manufacturing environments where our product is incorporated as a functional intermediate or process aid, addressing authentic sector requirements at the formulation, compliance, and finished-goods level.

    1. Pharmaceutical Active Pharmaceutical Ingredient (API) Synthesis

    Leading pharmaceutical manufacturers utilize this compound in multistep peptide API synthesis, taking advantage of its structural properties for selective peptide assembly and protection strategies. Our customers integrate the material at the protected amino acid stage, particularly in solid-phase peptide synthesis (SPPS) and solution-phase synthesis, enhancing process throughput and chiral purity. The compound’s use is tailored by process yield and sequence length, and facilities comply with cGMP and pharmacopeial validation. Its application is critical in routes where side-chain protection of leucine residues prevents undesired reactions during stepwise elongation.

    Industry compliance standards

    • ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients
    • US FDA 21 CFR Part 211 (Finished Pharmaceuticals)
    • European Pharmacopoeia (Ph. Eur.) monographs for amino acid derivatives
    • Japanese Pharmacopoeia (JP) requirements for API intermediates

    Typical usage ratio

    • Protection agent added at 1.1 to 1.5 molar equivalents per leucine residue; actual ratio determined by solid- or solution-phase loading density and targeted peptide chain length

    Downstream process integration

    • Introduced at the protected amino acid step in SPPS resin loading or solution-phase elongation; removed during deprotection and cleavage; process validated by in-process HPLC and purity assays

    Final product types

    • Peptide-based APIs for injectable therapeutics, diagnostic peptides, pharmaceutical intermediates supplied for further downstream conversion

    2. Peptide Custom Synthesis and CRO Manufacturing Services

    Contract manufacturing and research organizations employ this raw material extensively for synthesizing custom peptides and peptide-like molecules for biotechnology R&D. The protected leucine derivative serves a critical function during scale-up of non-clinical trial batches, ensuring sequence-specific N- and C-terminal modifications. Quality-focused operations use this intermediate to achieve reproducible batch characteristics when handling complex or hydrophobic peptide sequences, adhering to ISO certification and data integrity expectations throughout the workflow.

    Industry compliance standards

    • ISO 9001:2015 Quality Management for chemical synthesis
    • OECD Principles of Good Laboratory Practice (GLP) for non-clinical studies
    • US Pharmacopeia (USP) quality standards for research grade chemicals
    • Traceable lot release documentation following ICH Q10 Pharmaceutical Quality System

    Typical usage ratio

    • Typically 0.2–5% w/w relative to total amino acid input; precise loading dictated by sequence length, synthesis strategy, and hydrophobicity requirements

    Downstream process integration

    • Fed directly to automated peptide synthesizers at the protected amino acid loading stage, with cycle times and coupling monitored for complete residue incorporation and minimal racemization

    Final product types

    • Research peptides for academic and biotech use, reference standards, diagnostic assay substrates, and high-purity peptide controls

    3. Specialty Chemical Building Block for Chiral Fine Chemicals

    Fine chemical producers utilize this intermediate as a chiral source in asymmetric synthesis routes, supplying downstream manufacturers of specialty reagents and additives. The material’s tert-butyl-ester form enables selective transformations yielding chiral molecules for advanced organic chemistry applications. Producers run multi-kilo batches under strict process controls to ensure reproducible optical purity and yield, with documentation meeting relevant ISO systems for non-pharma chemical manufacture.

    Industry compliance standards

    • ISO 9001:2015 Quality Management for chemical production
    • REACH (EC Regulation 1907/2006) for registered intermediate registration and handling
    • Responsible Care® chemical safety management
    • Custom specification agreements with leading agrochemical and fine chemical buyers

    Typical usage ratio

    • Introduced at 1:1 stoichiometry in asymmetric alkylation, reductive amination, or acylation steps; actual ratio based on downstream target and reaction conversion

    Downstream process integration

    • Enter as a primary chiral feedstock at the initial condensation or amidation stage; subsequent processing includes hydrolysis, purification by crystallization, and quality control via chiral chromatography

    Final product types

    • Optically pure chemical intermediates, chiral resolving agents, and advanced building blocks for fragrance, agrochemical, and electronics-grade specialty chemicals

    4. Protected Intermediate in API Impurity Reference Standard Production

    Certified reference materials (CRMs) and impurity standards producers incorporate this esterified leucine derivative during synthesis of peptide or API impurity markers used in pharmaceutical analysis. Laboratories require this intermediate to generate structurally defined impurities with tight analytical specifications, supporting regulatory submissions and QC method development. The process emphasizes traceability, audit trails, and batch homogeneity, using quality assurance frameworks critical for ISO Guide 34 or ISO 17034 conformity.

    Industry compliance standards

    • ISO 17034:2016 General requirements for the competence of reference material producers
    • ISO/IEC 17025:2017 for accredited analytical laboratories
    • Allergen labeling and composition disclosure for global pharmaceutical compliance
    • European Medicines Agency (EMA) guidelines for impurity standards

    Typical usage ratio

    • Applied at 0.2–2.0% w/w relative to bulk API; the specific amount depends on targeted impurity level and analytical method sensitivity

    Downstream process integration

    • Employed during targeted side-chain modification or labeled impurity synthesis; integrated prior to purification, followed by rigorous batch-testing for structural identity and quantitative assay

    Final product types

    • API impurity reference standards, certified peptide markers, analytical substances supplied to QC laboratories and regulatory compliance bodies

    5. Amino Acid Derivative for Diagnostic Reagent Manufacturing

    Diagnostic reagent producers formulate this protected leucine ester derivative to prepare enzyme substrates or calibration standards used in clinical testing kits. The controlled deprotection and coupling characteristics allow precise construction of synthetic peptides or derivatives forming the analytical component in immunoassays and in vitro diagnostic (IVD) test strips. All materials are handled under ISO 13485 protocols to ensure biocompatibility, lot traceability, and reproducibility across production campaigns.

    Industry compliance standards

    • ISO 13485:2016 for medical device and IVD reagent manufacturing quality systems
    • FDA 21 CFR Part 820 (Quality System Regulation) for diagnostic components
    • CLSI guideline EP25-A for assay calibration and lot standardization
    • EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746

    Typical usage ratio

    • Typically integrated at 0.3–1.0 molar equivalents in substrate or peptide synthesis steps for diagnostic kit production; amount refined based on required analytical sensitivity

    Downstream process integration

    • Enters during controlled peptide assembly or conjugate formation, followed by deprotection, purification, and incorporation into assay or detection components following validated in-process control parameters

    Final product types

    • Enzyme substrates for diagnostics, peptide-based calibration standards, IVD assay components for clinical laboratories
    Free Quote

    Competitive L-Leucine Tert-Butyl Ester 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

    L-Leucine Tert-Butyl Ester Hydrochloride: A Closer Look from the Manufacturer’s Perspective

    Where Chemistry Meets Industry Demand

    In the chemical manufacturing industry, L-Leucine Tert-Butyl Ester Hydrochloride stands out as a specialty product that deserves more discussion than it usually gets. It’s not just another amino acid derivative on the shelf; it’s a reliable workhorse in complex synthesis, especially when purity and protection strategies are crucial to the final application. Customers frequently ask about its intended uses, how it performs in real-world lab setups, and how it compares to other similar materials. As a team dedicated to real chemical production, not just supply chain trading, we’ve spent years refining both process consistency and product quality to meet research and commercial batch requirements.

    What Goes Into Our Manufacturing Process?

    Producing L-Leucine Tert-Butyl Ester Hydrochloride starts with selecting the right grade of L-Leucine as a starting material. Only leucine that meets strict analytical criteria for stereochemical purity and minimal impurities enters our facility’s esterification stage. During manufacturing, maintaining clean reaction conditions and careful temperature controls gives a product batch with tight purity specs. We regularly achieve contents over 99% by HPLC on the final crystalline hydrochloride salt. We don’t rely on chance or luck to meet such benchmarks—our plant runs with full traceability of each intermediate, real-time in-process control, and immediate adjustments if analytical checks suggest even minor deviations.

    Constant monitoring does more than serve regulatory needs. It prevents batch failure. Moisture content matters tremendously for this product—think of the challenges downstream when a poorly protected ester group reacts with water before the customer ever gets their hands on it. Once, after a month with unexpected humidity in the mid-70% range, we identified microtraces of hydrolysis in a drying chamber far from the main reaction hall. That prompted an overhaul of our air handling system and direct lot-locking of all batches until QC cleared them. As a result, our release specification for water content now rests below 0.5%, based on direct Karl Fischer titration.

    Defining Model and Specifications that Matter in Daily Use

    Each facility uses its own batch designation system, but the real difference for clients comes in assurance of reproducibility and the clean, white crystalline appearance that speaks to well-controlled crystallization. The hydrochloride salt format increases handling safety and storage stability, compared to the free ester base, which can volatilize or degrade if left exposed for too long. Chemists in peptide manufacturing, prodrug synthesis, and pharma research repeatedly report fewer unwanted side reactions and easier product workup using our material over generic market imports.

    Granularity can also affect the ease of dissolution during downstream use. We’ve tuned our particle sizing for both ease of weighing and rapid dispersibility in standard peptide coupling solutions. The powder’s direct solubility in methanol, ethanol, dichloromethane, and DMF reflects that care in isolation and drying. We’ve seen project timelines tighten on the customer’s end just because a good batch of L-Leucine Tert-Butyl Ester Hydrochloride shaved hours off the preparation stage.

    Trace metals pose another concern, especially for API and clinical candidates. By screening every raw material lot and using reactor linings certified for materials compatibility, we keep heavy metal content well below regulated parts-per-million limits. ICP-MS analysis backs our reporting, and those certificates ship with each filled drum.

    Why L-Leucine Tert-Butyl Ester Hydrochloride Makes the Difference in Advanced Synthesis

    Most scientists working in peptide modification and building block extension face hurdles with selectivity and unwanted side-reactions. In these workflows, the tert-butyl ester function acts as both a protecting group and a solubility enhancer—attributes that make difficult couplings proceed more cleanly. Where methyl or ethyl esters have a tendency to hydrolyze or trans-esterify under less-than-ideal conditions, tert-butyl delivers higher resistance to both acid and base, yet still removes cleanly at the right step using relatively mild acidolysis.

    I’ve watched teams comparing micro-scale model reactions, running methyl ester, ethyl ester, and tert-butyl ester under the same coupling conditions. Yields often slide downward for methyl esters due to competing hydrolysis or even simple evaporation over the reaction. The tert-butyl ester, by contrast, endures longer and gives consistent conversion, even in longer synthetic cycles where intermediate handling happens multiple times.

    There’s a misconception that all amino acid esters stand as equals on a chemistry bench. Handling hundreds of gram-scale and kilo-scale batches yearly, we’ve seen firsthand that tert-butyl groups last through the multi-step routes most pharmaceutical labs follow. Free amino acid ester, while cheaper, usually suffers decomposition well before purification. Many of our clients who used to depend on methyl or ethyl versions moved their protocols to tert-butyl (HCl salt) for higher batch-to-batch repeatability and easier downstream processing.

    Applications That Drive Recurring Demand

    Organic synthesis groups, peptide assembly lines, and medicinal chemistry teams find repeated use for L-Leucine Tert-Butyl Ester Hydrochloride beyond its text-book definition. In solid-phase peptide synthesis (SPPS), its profile as a masked amino acid segment reduces racemization and protects integrity under the main coupling and deprotection sequences. Peptide engineers working with branched or sterically crowded motifs actively seek out tert-butyl ester forms because alternatives tend to create impure mixtures or lead to byproduct that complicates mass spectrometry and chromatography.

    Beyond peptide work, custom manufacturing for small-scale APIs highlights another facet—tert-butyl esters impart advantageous solubility for intermediates that otherwise precipitate or stick to glass during process filtration. One longtime partner developing a leucine-based drug conjugate noted a dramatic cut in waste and rework once their process moved to using fresh tert-butyl ester, rather than aged material or generic samples of uncertain storage stability.

    Among life sciences companies preparing labeled derivatives for imaging, or synthons for combinatorial chemistry, our product’s chromatographic clarity and low baseline noise supports downstream characterization using NMR and mass spec with far fewer artifacts. This all comes back to our tight controls and pro-active QC, not to mention the time we’ve invested in tweaking recrystallization and drying protocols batch by batch.

    Differences from Other L-Leucine Derivatives and General Amino Acid Esters

    It pays to look deeper than just the catalog page when choosing between amino acid esters. L-Leucine methyl ester and L-Leucine ethyl ester each have a track record among chemists, but both encounter stability issues during storage and handling, most notably with higher humidity exposure. Free L-Leucine Tert-Butyl Ester suffers volatility and poor shelf life, especially in non-hermetic packaging, making laboratory supply logistics a challenge.

    Bulk buyers sometimes compare L-Leucine Benzyl Ester HCl as an alternative, chiefly for certain coupling strategies, but that version brings along a bulkier protecting group and introduces benzylic reactivity under hydrogenation or reductive conditions, often pushing chemists to redesign workflows or redo purification. Tert-butyl groups introduce none of that, offering selective removal and less interference in analytical runs.

    Direct field experience shows that shelf-stable hydrochloride salts maintain consistent melting range and powder flow even over extended warehousing—qualities distributors often overlook until late in the supply cycle. Over years of feedback, the ester’s low hygroscopicity scores high marks from repeat customers. As a result, returns and expired-batch incidents dropped sharply once we locked in the current hydrochloride isolation process.

    Compared to standard L-Leucine, the esterified hydrochloride enables a leap in molecular handling, as the ester blocks the carboxyl while leaving the amine fully available for selective transformations. That allows for more creative chemical modifications and branching—the sort of innovation that pushes pharmaceutical research forward. Our approach keeps side products minimal and supports challenging synthetic designs, such as preparing optically pure dipeptides or unusual cyclic peptides.

    Supporting Research and Commercial Projects

    As a manufacturer, we listen to feedback from clients developing everything from new protease inhibitors to high-potency peptide mimetics. They don’t just want certificates; they want reliable, hassle-free material, clear guidance on storage best practices, and assurance on batch repeatability. That’s why our team always photographs representative powder for archive reference, cross-verifies every shipment with full spectroscopic data, and consults directly with those needing process adaptation tips.

    Early-stage pharma applicants, in particular, benefit from our lot continuity and stability data. We’ve seen how the difference between a faultless HCl salt and an off-spec batch can translate to whole project setbacks or expensive troubleshooting. Stability studies conducted at both room temperature and refrigerated conditions show consistent retention of both assay and optical rotation, confirmed by repeat HPLC and polarimetric testing over six months or more.

    Custom project managers sometimes request modified lot sizes—anything from pilot 100 g runs to full 25 kg drums—depending on research phase or production scale. Our flexible batch planning helps smooth their timeline, letting them swap between pilot and scale-up with product lots drawn from the same process history. Some of the leading contract research organizations have written to us about the time and cost saved with this approach, considering traceability back to starting amino acid and document packs with each shipment.

    Solving Problems Together with Chemists and Engineers

    Experienced researchers often bring up concerns that only appear after a few failed attempts with less-refined material: mysterious impurities, inconsistent moisture content, or tricky dissolution profiles. Open lines of communication have made a difference here—we invite customers to share side-by-side results or show chromatographic runs when they hit a challenge. Sometimes the solution is as simple as scheduling a new drying sequence; sometimes, we go back to the drawing board, reviewing starting raw materials, updated supplier specs, or a tweak to post-crystallization washing.

    In supporting custom synthesis projects, we've worked closely with clients ramping up to GMP or near-clinical batch sizes. Beyond raw product supply, our technical support team consults on storage, solvent selection, or even in-line QC test suggestions tailored to each downstream process. One med-chem partner revamped their entire pre-coupling preparation just by revisiting the way tert-butyl ester was dissolved, slashing waste and gaining smoother throughput across peptide lines.

    We’ve heard stories from pharmaceutical plants where a missed moisture spike ruined weeks of work. That underscores why our facility maintains dedicated storage for this product in both ambient and climate-controlled warehouses. Each out-shipment includes desiccant-packed, tamper-evident drums. Even small changes, like routine inspection of powder morphology and quick feedback from the receiving lab, make a difference that ripples into client timelines and yield statistics.

    Facts and Figures to Guide Confident Usage

    Empirical data drives our decisions. Our analytical lab records for the last 40 consecutive batches of L-Leucine Tert-Butyl Ester Hydrochloride show mean HPLC purity consistently above 99.2%, with chiral purity by optical rotation checks exceeding 99%. Samples from each drum enter a reserve system for third-party verification, giving chemists peace of mind when comparative runs or regulatory filings require full disclosure or audit traceability.

    By designing our production pipeline to meet both gram-scale research and multi-kilo commercial use, the product’s consistency supports a wide range of applications, from academic peptide chemistry to small-molecule API building blocks. Even in the face of shifting regulatory frameworks or changing market demand, that adaptability means our product has continued to meet both current and future batch needs without re-validation or costly revisions.

    Continuous Innovation for Tomorrow’s Chemistry

    Making any specialty chemical requires more than lab-scale routines. We’ve incrementally refined each process stage, from vacuum drying to advanced particle sizing and surface modification, based on a steady stream of feedback from those running real-world synthesis. This hands-on collaboration led directly to tweaks in drying cycles, better impurity removal before salt formation, and more reliable lot archiving.

    We believe improvements should translate directly to customer results. Ongoing internal R&D monitors for new contaminants, explores solvent-free isolation, and tests alternative salt forms when industry partners request niche adaptations. That practical R&D lens means our current batch release standards were built through iterative learning, not static tradition.

    Regular staff training and hands-on workshops emphasize both safety and product-specific best practices, so each operator understands the downstream sensitivities of a chemically protected amino acid ester. Our team shares case studies internally, allowing lessons learned—like the time a misplaced desiccant pouch led to a moisture hitch—to tighten controls for future runs.

    Trust Built on Real Manufacturing, Not Just Distribution

    As an actual manufacturer, we handle every stage of the process ourselves. No batch moves beyond our doors until meeting internal criteria on purity, salt form, heavy metals, and moisture—criteria shaped by years of facing chemical synthesis challenges alongside our customers. Unlike distributors or catalog repackagers, our fingerprint rests on each drum and every certificate. If a customer questions a weird impurity peak or requests advice on solvent systems, answers come from those who designed and ran the batch.

    Over years of working alongside process chemists, academic labs, and formulation developers, we’ve come to appreciate the difference a consistent supply chain makes. Our reputation as the origin manufacturer—rather than a third-party relabeler—draws return business and builds a foundation of trust. Researchers tired of inconsistent market product or ambiguous specifications receive a clear lot lineage for every box shipped.

    From small R&D batches to high-volume industrial lots, every shipment stands on the work of real operators, chemists, and quality managers who own the results, not just the documentation. That responsibility keeps both product quality and technical support at the level our partners count on, batch after batch.

    Meeting the Next Challenge: Beyond the Product’s Traditional Scope

    Looking ahead, L-Leucine Tert-Butyl Ester Hydrochloride continues to evolve its place in the chemical industry. Proteomics, diagnostics, and new forms of peptide-drug conjugates keep raising the bar for purity, identity, and regulatory transparency. We see product batches heading toward even more stringent requirements for trace elements, chiral purity, and validated removal of every conceivable impurity. That’s where the lessons from our manufacturing past continue to fuel tomorrow’s improvements.

    Work on developing extended stability data, better-packaged units for smaller R&D groups, and real-time batch monitoring tools is already underway. By keeping core production in-house and sharing what we learn, we build not only better product but stronger collaborations with the next generation of synthetic innovators.