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Homocysteine

    • Product Name Homocysteine
    • Alias SRD5A3
    • Einecs 220-785-7
    • 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
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    Specifications

    HS Code

    229964

    name Homocysteine
    type Amino acid derivative
    chemical_formula C4H9NO2S
    molar_mass 135.19 g/mol
    CAS_number 454-29-5
    appearance White crystalline powder
    solubility Soluble in water
    storage_conditions Store at 2-8°C, protected from light
    clinical_use Biomarker for cardiovascular risk
    normal_range_serum 5–15 μmol/L
    measurement_method ELISA, HPLC, immunoassay
    synonyms 2-Amino-4-mercaptobutyric acid
    biological_role Intermediate in methionine metabolism

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

    Packing & Storage
    Packing The Homocysteine packaging contains 1 gram of white crystalline powder, sealed in an amber glass vial with a secure screw cap.
    Shipping Homocysteine should be shipped in a tightly sealed container under cool, dry conditions. It is recommended to use insulated packaging with ice packs or dry ice to maintain low temperatures, preventing degradation. Shipments must comply with current regulations and include appropriate labeling and documentation for safe transport as a laboratory chemical.
    Storage Homocysteine should be stored in a tightly sealed container, protected from light and moisture, at a temperature of 2–8°C (refrigerated). It should be kept away from incompatible substances such as oxidizing agents, acids, and bases. Proper labeling and secure storage in a well-ventilated, designated chemical storage area are essential to prevent contamination and degradation.
    Application of Homocysteine

    Applications of Homocysteine in Industrial Manufacturing

    Homocysteine serves as a specialized raw material for targeted applications in advanced chemical, pharmaceutical, and nutraceutical manufacturing. As a producer, we supply this compound to select industrial sectors where its biochemical properties directly enhance synthetic processes, ingredient profiles, and analytical standards. Below, we outline the key application scenarios, compliance expectations, formulas, usage levels, process steps, and major downstream product categories.

    1. Active Pharmaceutical Ingredient (API) Intermediate for Cardiovascular Drugs

    Drug manufacturers use our material as an intermediate in multi-step synthesis of specific active ingredients, particularly in cardiovascular drug development. Its thiol group and biochemical pathway relevance make it essential for precise molecular construction during the production of antihyperhomocysteinemia agents. The raw material is subject to all applicable pharmaceutical regulations governing ingredient purity, handling, and trace residuals. Industrial formulators carefully control the dosage due to strict process validation and regulatory batch release criteria. Our technical support aligns with downstream GMP protocols and documentation requirements for this segment.

    Industry compliance standards

    • ICH Q7 GMP for Active Pharmaceutical Ingredients
    • USP/NF Monographs (where applicable, as reference standards)
    • European Pharmacopoeia (Ph. Eur.) material purity criteria
    • FDA DMF registration and cGMP audit requirements for U.S. drug manufacturers

    Typical usage ratio

    • 0.1%–2.5% w/w in early- and mid-stage synthesis steps, adjusted according to yield optimization, desired stereochemistry, and trace impurity allowances defined by the target API specification.

    Downstream process integration

    • Directly charged into kilogram-scale reactor vessels during active intermediate formation; monitored throughout condensation, reduction, or derivatization routes. Sourcing logs and material traceability are maintained from weigh-in to post-reaction purging and workup steps.

    Final product types

    • Bulk pharmaceutical molecules for anti-thrombotic and folate-modulating agents like betaine formulations and proprietary investigational drug substances.

    2. Reference Standard in Clinical Laboratory Diagnostics

    High-purity lots are supplied for in vitro diagnostic reagent and calibrator kit preparation, as homocysteine quantitation forms a diagnostic marker in clinical testing for cardiovascular risk. Downstream IVD kit manufacturers follow rigorous analytic validation, linearly precise spiking, and lot-specific calibration to meet global medical device directives. Traceable, controlled formulations ensure reference standards meet both precision and safety requirements in final diagnostic applications.

    Industry compliance standards

    • ISO 13485:2016 Medical Device Quality Management Systems
    • In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746)
    • U.S. FDA 21 CFR Part 820 (QSR) for diagnostic devices
    • Clinical and Laboratory Standards Institute (CLSI) recommendations for calibration traceability

    Typical usage ratio

    • Defined at 0.05–0.4 mmol/L in calibrator, control, and proficiency testing formulations. Adjustment based on analyzer sensitivity and kit manufacturer verification protocols.

    Downstream process integration

    • Homocysteine is reconstituted to defined concentrations in aqueous or lyophilized reference matrix, sterile-filtered or aseptically processed. It enters calibrator or standard solution batch blending, followed by vial-filling, lyophilization, and QC certification.

    Final product types

    • Diagnostic calibration standards, quality control solutions, and proficiency testing materials for use in automated homocysteine assay systems (immunoassay, HPLC, LC-MS/MS platforms).

    3. Precursor for Specialty Nutritional and Metabolic Research Compounds

    Research-grade homocysteine is used as a starting substrate by nutraceutical and specialty supplement manufacturers as part of custom in vitro metabolism studies and for the generation of folate-cycle intermediates. Formulators use carefully measured input to develop pilot batches of compounds for preclinical dietary evaluation. Strict ingredient accounting and scientific documentation underpin process and analysis, especially as regulatory boundaries differ for nutritional versus medicinal use in each export market.

    Industry compliance standards

    • ISO/IEC 17025:2017 for laboratory use (analytical chemistry, research applications)
    • Relevant national food safety authorities such as EFSA (EU), FDA (U.S.) for research-use-only status
    • GMP for Dietary Supplements (21 CFR Part 111, where applied in U.S. facilities)
    • Food Chemicals Codex (FCC) quality references (as applicable for select intermediates)

    Typical usage ratio

    • 0.05%–0.5% w/w in metabolic study samples or model compound preparations; adjusted to research protocol, target metabolite yield, and source raw material assay limits.

    Downstream process integration

    • Homocysteine is introduced into synthesis flasks or cell-culture additives at the preformulation or pilot-scale synthesis stage, with all additions fully documented. Excess residuals are quantified via validated HPLC or LC-MS/MS method development workflows.

    Final product types

    • Metabolic research compounds (e.g., S-adenosylhomocysteine, methylation cycle intermediates), pilot-scale folate and B-vitamin pathway metabolites for preclinical study kits.

    4. Biochemical Reagent for Amino Acid Assay Kit Manufacturing

    Producers of amino acid analysis kits utilize high-grade material for internal calibration, quality controls, and proficiency testing components during kit assembly. Quantitative accuracy and minimal matrix interference demand tight control over formulation inputs and finished material verification. Process execution follows established biochemical reagent QC workflows and complies with region-specific kit registration requirements for laboratory supply chains.

    Industry compliance standards

    • ISO 9001:2015 for chemical manufacturing QC
    • GLP (Good Laboratory Practice) for reagent production and lot traceability
    • REACH Regulation (EC 1907/2006) for European market entry
    • Safety Data Sheet (SDS) and chemical inventory compliance

    Typical usage ratio

    • Typically 0.1–0.3 μmol in working calibration samples or per kit standard, with specific levels assigned per instrument platform and analytic detection requirements.

    Downstream process integration

    • Integrated during standard solution preparation, followed by volumetric transfer to vials and stabilization (with reducing agents or lyophilization assistants if required). Each lot undergoes stability and performance validation against traceable standards.

    Final product types

    • Amino acid assay kits, proficiency testing sets, and internal quality control materials for analytical, clinical, and biotechnology lab applications.
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    Certification & Compliance
    More Introduction

    Homocysteine: Precision in Synthesis From the Ground Up

    Approaching Homocysteine with a Manufacturer’s Eye

    Producing Homocysteine moves far beyond sourcing building blocks or following established recipes. Years spent on the shop floor and in the laboratory have shown that the quality of this amino acid comes down to close control of every step, from raw material purity to purification and analytical verification. We see requests for Homocysteine with precise requirements because medical research and diagnostics demand more than commodity-grade material. Every batch we make tells a story about process yield, handling careful reaction conditions, and attention to subtle impurities.

    Homocysteine, by formula C4H9NO2S, often appears as a white to off-white crystalline powder. Its structure holds a thiol group that sets it apart from more familiar amino acids like methionine or cysteine. In protein synthesis and metabolic research, Homocysteine acts as a key intermediate. Traditional production routes use enzymatic or chemical hydrolysis. Some research applications need enantiomeric purity, which means we often use asymmetric synthesis or chiral-resolved intermediates, followed by strict monitoring for byproducts and isomer content.

    Specifying Homocysteine: Why Details Make the Difference

    Researchers working with Homocysteine rarely accept off-the-shelf products without a second thought. There’s a good reason for that. Batch-to-batch consistency can affect the results of homocysteine-level testing, protein modification experiments, or in-vitro cellular studies. Our product carries a typical purity above 98% (measured by HPLC), and we routinely analyze for related compounds – particularly cysteine and methionine, which might slip in during synthesis. Moisture content, sulfate, and heavy metal traces get equal scrutiny. Unchecked, these can skew results in sensitive biochemical assays.

    Working at production scale, we fine-tune crystallization temperature and solvent ratios to avoid unwanted oxidation and to minimize formation of homocystine, which can appear if air or light exposure isn’t controlled. The real challenge comes with packaging and storage. Homocysteine absorbs moisture and can oxidize. Sealing each batch with nitrogen and storing at low temperatures slows degradation. We scale this process up without drifting from these principles, using the same techniques for gram-scale research batches and multi-kilogram custom productions.

    Model and Application Landscape: Where Homocysteine Goes to Work

    Most customers come to us for high-purity DL-Homocysteine. Some need the specific L- or D- enantiomers for stereospecific research. Diagnostic kit manufacturers use our Homocysteine to calibrate assays for cardiovascular risk assessment. Unlike many other amino acids, homocysteine levels reflect methylation status and sulfur metabolism, which makes our product a linchpin for biomedical research. Our experience has made us sensitive to the needs of clinical reference labs – they demand certificates of analysis, stability data, and traceability to international reference standards.

    Besides diagnostics, some contract research organizations and pharmaceutical labs use our Homocysteine for developing enzyme inhibitors, mapping metabolic pathways, or probing oxidative stress in cell models. In these cases, the form of Homocysteine matters. Some projects demand the free amino acid; others prefer the crystalline hydrochloride salt for easier solubility. Our process allows us to tailor the physical form so researchers start each experiment with exactly what they expect, minimizing downtime from solubility issues or re-purification.

    Homocysteine vs. the Alternatives: Not All Amino Acids Are Equal

    Comparisons get drawn between Homocysteine, its precursor methionine, and related sulfur-containing compounds. From a synthetic angle, methionine is more robust. Homocysteine needs extra steps to prevent oxidation. Many in research or clinical use assume the two are interchangeable; this is a mistake. Metabolic pathways treat Homocysteine and methionine quite differently. Our customers in nutritional and metabolic studies rely on our attention to these differences so their findings remain credible.

    Stability sets Homocysteine apart from common amino acids like glycine, alanine, or even cysteine. Free thiol groups lend reactivity but introduce storage hazards. Our staff has learned not to underestimate the impact a slight increase in storage temperature or improper sealing can have, especially in humid climates. This reality steers our quality team to test accelerated storage conditions, not just baseline stability, so we can offer confident shelf-life recommendations.

    Quality Systems Earn Trust

    Medical and academic researchers place heavy value on documentation as much as chemical purity. Each Homocysteine batch comes with rigorous analytical reporting. Every specification – purity, isomer ratio, moisture, residual solvents, and trace elements – meets quality systems built for the life-science sector. We use validated methods with cross-checked calibration. Failed tests push us back for process troubleshooting, not out the door into waste.

    This level of rigor does bring higher costs compared to bulk commodity amino acids. Some procurement teams ask for technical justification. They see a number on a page and question the difference. But being on the manufacturer’s side, we see lives depending on reproducibility. A failed diagnostic kit or inconsistent measurement of plasma Homocysteine can trigger incorrect patient care. Experience has taught us the burden of proof sits with the maker. We offer batch traceability and transparent quality review because the researchers and clinicians trusting our product expect no less.

    Market Trends: More Than Just Volume

    Over the past decade, global trends in cardiovascular, neurodegenerative, and prenatal research pushed the demand for Homocysteine up. For a time, commodity traders tried to meet this demand with imports of isolated material, often from vendors who couldn’t guarantee purity or documentation beyond a basic label. These products sometimes showed up with visible discoloration or unexplained peaks in HPLC analysis.

    In our manufacturing facility, investment in analytical technology and raw material screening sets the standard. We routinely reject material that shows even minor nonconformance. Automation supports process repeatability but cannot replace experience. The team managing Homocysteine production includes people who have handled the same process for years, catching shifts in color, texture, and aroma that signal a batch drifting out of spec. These old-school skills combine with top-line equipment to guard against market shortcuts.

    Regulation tightened as more countries updated import and clinical trial requirements for research chemicals. These changes directly impact specification standards for Homocysteine. Manufacturers who cut corners or rely on outdated quality systems wind up with product on import hold. Meeting international requirements is more than paperwork; it comes down to the quality controls and traceability woven throughout manufacturing.

    Lessons Learned Over Years of Homocysteine Production

    Scaling up Homocysteine synthesis is anything but a turnkey operation. Temperature and pH swings can shift product yield and purity unpredictably. During purification, minor variations in solvent grade or tank cleaning can introduce contamination. Our operators don’t chase productivity at the expense of consistency. Weekly debriefs and troubleshooting sessions help. By facing batch failures and learning from them, we build process stability into each production run.

    We learned to manage material loss through careful batch accounting and solvent recycling. Unreacted intermediates and process residues don’t just disappear; they have to be contained, treated, or safely destroyed. Increasing expectations for clean, responsible production means we can’t ignore environmental controls. Waste minimization isn’t new, but the urgency is. Customers increasingly want proof that the Homocysteine they order doesn’t burden their own environmental compliance or provide any safety surprises.

    Technical Hurdles and Continuous Improvement

    Practically, manufacturing Homocysteine demands persistent improvement in small details that make the difference between good and great product. For instance, handling reactive intermediates safely in larger vessels calls for frequent checks on gaskets, pumps, and joint seals. We’ve found that investing in slightly higher-grade reactor materials pays for itself through fewer product recalls and maintenance stops.

    Tunability comes not from buzzwords but from lots of trial and error. Adjusting crystallization rates for different batch sizes or downstream uses can mean subtle shifts in process parameters that aren’t always intuitive. Feedback from our client labs sometimes identifies issues our internal testing didn’t catch – especially around sample solubility in final applications.

    Process changes never happen overnight. Each time we tweak parameters to improve yield or purity, we plan side-by-side batch runs and compare against reference material. Any visible difference gets immediately flagged and reviewed. We keep careful records of every critical material and process change, ensuring our production history supports regulatory and quality reviews.

    Supporting Advanced Applications

    Clients seeking Homocysteine for advanced life sciences work often drive us to innovate beyond classic synthesis. Incorporating isotopic labels or producing ultra-low impurity lots stretches our development team. This goes beyond business growth. We see it as a responsibility to push the science forward, not just ship packages. By partnering closely in the research community, we often pilot custom requests, providing technical insight based on our years producing this molecule.

    Environmental and safety profiles take precedence when supporting pharmaceutical or biotech partners. Regulatory review means submitting full documentation, including impurity profiling and residual solvent studies. Our engineers attend industry workshops and technical roundtables to keep ahead of new guidelines, making sure our product never falls behind in requirements or safety expectations.

    Fine-tuning particle size has emerged as a focus area for some recent biomedical customers. They discovered that smaller crystals dissolve faster in high-throughput screening platforms, whereas coarser material stores better for long-term stability studies. With this feedback, we modified our milling and sieving setup, providing tailored lots on request and monitoring for any resulting shifts in impurity profile or product longevity.

    Practical Considerations: Storage, Handling, and Field Results

    Handling Homocysteine successfully at the end-user site depends on more than just our efforts in the factory. We advise partners to store material tightly capped in cold, dry environments, away from oxidizing agents. Packaging in inert atmospheres proves effective at preserving integrity through extended shipping and storage. Years of experience confirm that any breach in seal integrity can lead to powder caking, color change, or odor—red flags for compromised material. This kind of product experience sets apart manufacturers who treat Homocysteine with the care it deserves.

    We often invite customers to discuss their workflows and share feedback on real-world uses of our product. Researchers encountering solubility challenges or unexpected background noise in chromatographic analysis help direct our R&D efforts. These collaborations generate new packaging materials and process modifications to reduce user-side frustrations and sharpen performance for all applications.

    No process is unbreakable. Supply disruptions, raw material shortages, and logistics complications have tested our flexibility. We maintain backup plans for multiple sourcing, batch reserves, and continuous dialogue with shipping partners to keep material flowing, even under constrained conditions. Practice and preparation, not just optimism, keep our delivery promises intact.

    What Sets Our Homocysteine Apart?

    Our track record grew through real-world problem-solving, not just compliance with basic specifications. Years spent supporting researchers and industry partners sharpened our understanding of what matters most: purity measured in every batch, robust documentation, reliable shipping, and real engagement with customer concerns.

    Inside every container of our Homocysteine are the stakes of scientific discovery, clinical assessment, or advanced therapy development. Mistakes or shortcuts ricochet through downstream applications. Our work shows up not in theoretical best practices, but in the consistent reliability of the lots we send out and the confidence of the teams who receive them.

    It’s easy to talk about quality on spec sheets or in sales meetings. For those of us in manufacturing, quality gets measured when returned material doesn’t show up, when customer experiments run without headaches, and when published research cites reproducible methods. We take pride knowing our Homocysteine stands as a foundation others can trust, day after day, project after project.

    Continuous Growth With an Eye on the Future

    The scientific and diagnostic world keeps evolving, and with it the requirements for chemical quality and traceability. As personalized medicine advances and research into methylation and metabolic pathways deepens, expectations for Homocysteine’s reliability grow. We’re ready to invest in process automation, sustainability, and technical partnerships to meet the next challenges in this field.

    Empathy for the bench scientist and respect for the clinical technician drive our business forward. We never lose sight of the demanding environments where Homocysteine finds use. Each time a new batch leaves our facility, it represents not just our labor but a commitment to better science and safer healthcare.

    There’s a tangible satisfaction in making something right, seeing it succeed in a customer’s hands, and learning from shared experience. This is what it means to manufacture Homocysteine at a level where every detail matters and every gram supports a larger purpose. We look forward to continuing that work, learning with and from the people who trust the product every day.