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DL-Penicillamine

    • Product Name DL-Penicillamine
    • Alias Cuprimine
    • Einecs 213-431-0
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry admin@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    990554

    Product Name DL-Penicillamine
    Chemical Formula C5H11NO2S
    Molecular Weight 149.21 g/mol
    Cas Number 52-67-5
    Appearance White to off-white crystalline powder
    Solubility Soluble in water, slightly soluble in ethanol
    Melting Point 212-218°C (decomposes)
    Storage Conditions Store at room temperature, protected from light and moisture
    Usage Chelating agent, treatment of Wilson's disease and rheumatoid arthritis
    Ph Value Approximately 4.5 (1% solution in water)

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

    Packing & Storage
    Packing DL-Penicillamine, 25g: Supplied in a sealed amber glass bottle with tamper-evident cap, labeled with chemical details and safety information.
    Shipping DL-Penicillamine should be shipped in tightly sealed containers, protected from light and moisture. It should be stored at a temperature between 2-8°C (refrigerated) and handled in accordance with safety guidelines for hazardous chemicals. Proper labeling and documentation are required to comply with regulatory shipping standards.
    Storage DL-Penicillamine should be stored in a tightly sealed container, away from light and moisture. It should be kept at a temperature of 2–8°C (refrigerated) and isolated from incompatible substances such as strong oxidizing agents. Ensure proper labeling and keep away from heat sources and direct sunlight. Store in a secure location, out of reach of unauthorized personnel.
    Application of DL-Penicillamine

    Applications of DL-Penicillamine in Industrial Manufacturing

    DL-Penicillamine serves as a critical intermediate and process additive in a select range of pharmaceutical, veterinary, diagnostic, and specialty chemical manufacturing sectors. Its applications span specific therapies and production processes, guided rigorously by international quality and regulatory requirements. Below, we detail its principal application scenarios with reference to current compliance standards, controlled incorporation ratios, integration into manufacturing flows, and the resulting end products.

    1. Active Pharmaceutical Ingredient for Wilson’s Disease Therapeutics

    DL-Penicillamine is widely formulated into final oral drugs for the management of Wilson’s Disease, acting as a chelating agent for copper detoxification. Pharmaceutical manufacturers integrate it into solid and liquid dosage forms, adhering to strict pharmacopoeial quality benchmarks. Accurate control of input ratios and direct blend incorporation during API production stages underpin process consistency, with continual in-process QC validation to ensure batch uniformity and patient safety.

    Industry compliance standards

    • USP (United States Pharmacopeia) Monograph for Penicillamine
    • EP (European Pharmacopoeia) 10.0 Monograph 01/2020:0127
    • ICH Q7 Current Good Manufacturing Practice Guidance for APIs
    • WHO GMP standards for pharmaceutical production

    Typical usage ratio

    • Final API compositions generally contain 90%–99.5% penicillamine by weight; excipient ratios adjusted based on tablet/capsule design and release profile

    Downstream process integration

    • Introduced at the wet granulation step or direct compression blending for oral solid dosage production
    • Used for solution preparation in liquid formulations via controlled dissolution, immediately prior to sterile filtration and filling

    Final product types

    • Prescription anti-copper tablets (e.g., 250mg/unit)
    • Oral solution bottles for clinical dosing

    2. Veterinary Medicines for Heavy Metal Poisoning Treatment

    Veterinary pharmaceutical producers employ DL-Penicillamine as a chelating agent in formulations targeting copper, lead, and mercury poisoning in animals. Precise raw material specifications and batch release controls are necessary to meet veterinary drug registration requirements. The material is blended into powder, suspension, or bolus forms as per therapeutic protocol, with dosage adjusted according to species and toxicity severity.

    Industry compliance standards

    • VICH GL39 Good Manufacturing Practice for Active Pharmaceutical Ingredients for Veterinary Use
    • US FDA Guidance for Industry #200 for Veterinary Pharmaceuticals
    • Relevant national veterinary pharmacopeias (e.g., Chinese Veterinary Pharmacopoeia)

    Typical usage ratio

    • 10–50 mg/kg animal weight per dose, with formulation strength adjusted by product line—corresponding to 6–40% penicillamine by mass in blended veterinary feed additive and premixes

    Downstream process integration

    • Dry blending with feed adjuvants or direct wet granulation for powders
    • Suspension homogenization and bottling for liquid veterinary applications

    Final product types

    • Veterinary medicinal bolus tablets
    • Medicated feed additives
    • Oral suspensions for livestock and companion animals

    3. Diagnostic Reagent Intermediate for Urine Copper Quantification Kits

    In the clinical diagnostics sector, manufacturers process DL-Penicillamine for use as a component in reagent kits for spectrophotometric measurement of copper excretion. The material’s chelation properties enable accurate analytical differentiation in patient samples. Producers of IVD kits source high-purity, contaminant-controlled batches to avoid interference in downstream analytical techniques, following strict validation procedures for kit manufacture and release.

    Industry compliance standards

    • ISO 13485 Quality Management Systems for Medical Devices
    • IVDR (EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices)
    • CLSI (Clinical & Laboratory Standards Institute) guidelines for reagent qualification

    Typical usage ratio

    • 0.05–0.5% w/v in diagnostic kit reagent solutions, titrated based on copper detection sensitivity targets

    Downstream process integration

    • Dissolution and mixing in buffered matrices during bulk reagent manufacturing
    • Terminal filling into single-use diagnostic kit vials

    Final product types

    • Urine copper assay reagent kits for hospitals and laboratories
    • Clinical biochemistry test panels for metal quantification

    4. Intermediate for Thiol-Based Specialty Chemical Synthesis

    Chemical manufacturers engaged in the synthesis of custom thiol-bearing organic compounds and metal chelate ligands incorporate DL-Penicillamine as a starting building block in multistep transformations. The unique thiol and amino functional groups provide core reactivity for forming high-purity specialty substances. Batches are tailored to customer synthetic requirements, with critical inspection of handling and in-process conversion efficiency to meet advanced industrial specifications.

    Industry compliance standards

    • REACH (EC No 1907/2006) for registration, evaluation, and authorization of chemical substances
    • ISO 9001:2015 Quality Management Systems
    • Internal specifications for trace metal and elemental impurity control (e.g., ASTM E29)

    Typical usage ratio

    • Stoichiometric or slight molar excess depending on downstream target, commonly 1–1.2 molar equivalents relative to primary reactants in condensation or chelation reactions

    Downstream process integration

    • Charged into reaction vessels during stepwise organic synthesis under inert or controlled atmosphere
    • Subjected to post-reaction isolation and purification steps (e.g., crystallization, solvent extraction)

    Final product types

    • Custom thiolated ligand precursors
    • Metal chelate intermediates for further processing into research chemicals or specialty catalysts
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    Certification & Compliance
    More Introduction

    DL-Penicillamine: Reliable Chelating Agent from the Manufacturer’s Bench

    Decades in the Lab: How Our Experience Shapes DL-Penicillamine Production

    Every batch of DL-Penicillamine leaving our site reflects years of chemical manufacturing experience. Our chemists stepped into this space after tracking the growing application of penicillamine in both medical and industrial detoxification. From the earliest days, production relied on close process control, from the reaction tank selection to the methodical handling of precursors. Those involved in developing our synthesis understood early on that market demands would favor a consistent product, free of extraneous isomers or unintended residues.

    At our facility, we start with quality-checked α-mercaptovaline and follow an optimized DL-racemization process, which yields a final powder with a high degree of purity. Our standard model, often requested in bulk form for pharmaceutical intermediate applications, typically follows USP standards. Granule size, color, and solubility get checked batch by batch; visual inspection and HPLC testing remain a daily part of our floor routine. A product that meets worldwide requirements for chelating agents cannot rely on luck — it depends on hands-on oversight and constant verification.

    DL-Penicillamine: Breaking Down What Sets It Apart

    Some manufacturers lean heavily into the clinical side when describing penicillamine, but on the production floor we see it as a multi-purpose compound. Its strong metal ion binding ability makes it a frequent choice in Wilson’s disease therapy and rheumatoid arthritis formulations, yet we field plenty of requests from environmental sectors needing copper or lead removal agents.

    Compared to L-penicillamine, the racemic DL form expands the field of application. The D-isomer, produced alongside L during our synthesis, does not carry biological activity in the body but proves useful in industrial processes where chirality is less crucial than overall chelating strength. This difference gives our DL-formulation two main advantages: flexibility in scale-up for customers who screen both isomers, and a broader shelf of downstream applications, from metal extraction to certain polymer additive routes.

    At the plant, we guard against over-oxidation and batch inconsistencies since these introduce off-color granules and reduce efficacy. By controlling for light and oxygen exposure, we deliver a product with minimal degradation and extended storage life. The signature odor, familiar to any worker who’s handled thiols, is a checkpoint for our QA staff, not just a nuisance; any deviation hints at production drift.

    Model Selection and Precise Product Control

    Our most common model, DL-Penicillamine with purity above 98%, reaches packing after breaking down into uniform granules. The fine powder dissolves readily in water and dilute acid, but some customers prefer a coarser grade for specific blending needs. We maintain specifications on moisture level, residual solvents, and trace metals — tough limits remain a habit from our experience serving intravenous drug companies.

    Batch release often hinges on tight melting point range and rapid-response elemental analysis. We regularly recalibrate our testing to reflect evolving pharmacopoeia standards. In direct manufacturer-to-end user relationships, traceability sticks with every batch and certificate of analysis. That earned trust is hard-won, as even a minor deviation in purity can upend a downstream reactor or trip regulatory audits.

    Direct Manufacturer Advantages Over Traders and Blenders

    A customer recently recounted problems sourcing penicillamine through a trading intermediary, receiving an off-white batch filled with insoluble particulates. Those relying on brokers sometimes end up chasing after paperwork and test results that never quite match samples. As a dedicated manufacturer, we own every stage of the chain, from purchasing primary reagents to packing the final product under GMP-compliant conditions.

    Handling thiol-based organics carries unique hazards and process quirks: ammonia evolution, strong odors, and the ever-present risk of side reactions. Our in-house chemists designed closed systems and implemented staged filtration that knocks back unwanted byproducts, producing a clean, reactive compound. Customers occasionally request custom specifications, and we adjust our synthesis accordingly since true manufacturers retain this flexibility. Those importing from bulk traders lose out on that level of collaboration.

    Key Usage Scenarios: From Medicine Cabinets to Wastewater Tanks

    Pharmaceutical companies source DL-Penicillamine as a starting material for finished drugs, banking on its established chelating profile against copper ions. By delivering strictly controlled particle sizes and tested solubility, we help formulators avoid downstream processing errors. Drug manufacturers look for tight compliance with pharmacopeia benchmarks as a matter of regulatory survival, not marketing posturing. Our plant operates tighter tolerance limits on all pharmaceutical-bound material than what typical brokers would entertain.

    We also track an uptick in environmental uses. Wastewater processors demand a reliable agent for non-biological heavy metal removal. Here, the DL form offers distinct advantages due to its cost profile and broad-spectrum activity. By producing in larger, economical lots, we meet the cost-per-kilo targets required for scalable remediation, providing greater assurance than lab-scale syntheses from boutique outfits.

    Research sectors stretch our product to even more innovative uses. Biomolecular scientists sometimes exploit penicillamine’s reactivity in protein denaturation or in kinetic studies of metal-thiol interactions. We consult on custom-packaged lots for academic studies, since researchers often call for different solvent or buffer compatibilities.

    Production Challenges and Solutions: Real-World Insights

    Running a penicillamine plant brings real technical headaches, especially in odor management and raw material reliability. Ammonia offgassing triggers alarms in any crowded workspace. Over a decade ago, our team switched from open crystallization vessels to sealed reactors, scrubbing both air and solvent phases. We pass vent lines through activated carbon filters, a step that carries operational costs but completely cleared ambient odor complaints from our line crews.

    Feedstock interruptions used to halt operations for days. To safeguard continuity, we invest in multi-year forward contracts with reputable alpha amino acid suppliers. By integrating alternate synthesis verification points, our QC personnel can halt a batch at the first sign of precursor drift. This hands-on troubleshooting cannot occur in a supply chain that outsources vital steps.

    Comparative Strengths: DL-Penicillamine Versus Other Chelators

    Chelating molecules crowd the market, from the common EDTA salts to more specialized agents like dimercaprol. What we witness on the ground is that penicillamine stands out due to its strong sulfhydryl group, bringing more binding affinity for soft metal ions in both clinical and environmental settings. Its origin as a penicillin byproduct also gives it a molecular structure less likely to introduce residual antibiotics or ring-structure impurities.

    EDTA, for all its commercial success, cannot outperform penicillamine in copper-heavy environments. Our own bench trials consistently show greater selectivity at lower concentrations, reducing the amount of chelator needed. In drug production, this means less worry about excess excipient build-up or patient side reactions.

    The broad application window our DL model provides appeals to every segment we supply, making it a staple in varied industries. The cost efficiency comes directly from a process built for scale, not from purchasing or blending and repackaging outside materials. New chelators enter the market regularly, but many suppliers underestimate the handling and regulatory risks of these alternatives. Reliability remains our calling card — it’s born from consistently stringent process oversight and customer transparency.

    Safety, Handling, and Worker Experience

    Few outside the plant realize how stepwise and hands-on the manufacturing of organosulfur compounds runs. Each barrel of DL-Penicillamine passes through trained hands, from initial formulation to final sealing. Safety drills, containment protocols, and exacting PPE standards shape everyday operations. By having our own staff handle every batch, we sidestep the attrition and errors endemic in rented labor or job-shop mixing.

    We document every incident, near-miss, and troubleshooting success. This institutional knowledge feeds back into each process review and every future order. Major upgrades in containment, powder handling, and real-time monitoring arose directly from operator suggestions. Chemical manufacturing benefits when those closest to the process drive continuous improvement, a fact third-party traders and distributors cannot replicate.

    Traceability and Trust: What Direct Manufacturing Means for Customers

    With regulatory scrutiny increasing worldwide, customers turn more frequently to direct manufacturers for full product traceability. From initial material sourcing, through synthesis, to final Certificate of Analysis, every lot of our DL-Penicillamine is documented and can be traced. If a question arises over contaminants, solvent residues, or production quirks, answers come straight from our in-house chemists — not anonymous intermediaries or outsourced QA offices.

    We field regular audits from international inspection bodies. Our production logs stretch back years, offering unmatched transparency for any downstream user. That level of documentation and accountability builds the kind of long-term confidence essential in pharmaceutical and industrial supply chains. With stricter global guidelines on medicinal ingredients and industrial chemicals, origin and detailed batch data have stopped being optional.

    Industry Demand Trends and Customer Insights

    Large-scale adopters of DL-Penicillamine increasingly seek not only top-grade product but also stability of supply, rapid response, and product customization. We take customer feedback as seriously as lab data. Whether batch size, granule type, or purity tweaks, nearly every improvement in our product line reflects the needs voiced by regular buyers.

    In recent years, unpredictable global supply chains drove up lead times and caused wild swings in pricing. By owning full production — synthesis down to finished product packaging — we insulated our customers from the worst spikes. Our batch process model gives us the flexibility to ramp output as needed for cyclical surges, impossible for resellers who rely on external production floors.

    Some pharmaceutical partners now request documentation and process validation to satisfy U.S. FDA or EMA audits. We have adapted, producing validation packages and sharing full testing data, easing concerns and helping customers pass their own inspections. This demand for deep compliance documentation reshapes how real chemical manufacturing must function in the modern age.

    Moving Forward: Innovation and Collaboration in Penicillamine Manufacturing

    The next evolution in penicillamine supply will not come from abstract innovations, but from ground-level refinements. We see greater automation in dispensing and real-time monitoring already boosting throughput without sacrificing hand-checked quality. Customization trends push us to invest in both new reactor setups and bottling lines capable of serving clinical, research, and industrial needs from the same plant.

    Customers keep pushing for green chemistry approaches and improved lifecycle analysis. Responding, we continue to invest in waste stream reduction and green solvent substitutions, learning each time from pilot projects and line-level operator insights. It’s clear the future of DL-Penicillamine manufacturing will remain inextricably linked to direct industry feedback and constant innovation.

    Conclusion: DL-Penicillamine Direct from the Source

    Producing high-grade DL-Penicillamine requires more than a formula and a supply contract. It takes commitment to traceability, obsession over quality, responsiveness to changing customer demands, and a long-term view to sustainability and process refinement. As a direct manufacturer engaged daily in raw material sourcing, synthesis, packaging, and global shipment, we continue to put our experience and process depth to work for every customer who depends on reliable, consistent chelating agent supply.