s carboxymethyl l cysteine

Introduction to S-(Carboxymethyl)-L-cysteine In the realm of advanced pharmaceutical and nutraceutical ingredients, s carboxymethyl l cysteine stands out as a critical compound. Also identified by its CAS number 638 23 3 , or simply cas 638 23 3 , this derivative of L-cysteine is highly valued for its mucolytic properties, making it an indispensable component in various therapeutic formulations. Its unique chemical structure, featuring a carboxymethyl group attached to the sulfur atom of cysteine, confers enhanced stability and bioavailability, setting it apart from other cysteine derivatives. This article delves into the intricate aspects of this essential compound, covering its industry relevance, technical specifications, manufacturing precision, and diverse applications. The demand for high-purity S-(Carboxymethyl)-L-cysteine is consistently growing across target industries such as pharmaceuticals, cosmetics, and specialized nutraceuticals. As regulatory standards become more stringent and consumer awareness about product efficacy and safety increases, the emphasis on robust manufacturing processes and stringent quality control for active pharmaceutical ingredients (APIs) and functional ingredients intensifies. Our commitment extends to delivering a product that not only meets but exceeds these industry benchmarks. Industry Trends and Market Outlook The market for mucolytics and respiratory health supplements is experiencing significant growth, driven by an aging global population, increased prevalence of chronic respiratory diseases like COPD and asthma, and rising environmental pollution. According to market analysis reports, the global respiratory drugs market, which includes mucolytics, is projected to reach over $50 billion by 2027, growing at a CAGR of approximately 5-7%. This trajectory directly impacts the demand for key ingredients like S-(Carboxymethyl)-L-cysteine . Beyond its primary role as a mucolytic, the compound's antioxidant properties are garnering attention in the nutraceutical sector for immune support and detoxification. In the cosmetic industry, its ability to support skin and hair health through cysteine replenishment is being explored in anti-aging and revitalizing formulations. The versatility of cas 638 23 3 ensures its sustained relevance and expansion into novel applications, pushing manufacturers to innovate in terms of purity, solubility, and formulation compatibility. Technical Specifications and Chemical Properties S-(Carboxymethyl)-L-cysteine is a white crystalline powder, highly soluble in water, and stable under appropriate storage conditions. Its molecular formula is C 5 H 9 NO 4 S, with a molecular weight of 179.19 g/mol. The presence of the L-configuration ensures its biological activity and compatibility in pharmaceutical applications. Key specifications are meticulously controlled to ensure therapeutic efficacy and safety. Product Specification Table: S-(Carboxymethyl)-L-cysteine Parameter Specification Method CAS Number 638-23-3 — Assay (on dried basis) 98.5% - 101.5% HPLC Appearance White Crystalline Powder Visual Specific Optical Rotation [α] 20 D +57.0° to +60.0° Polarimetry pH (1% solution) 2.5 - 3.5 pH Meter Loss on Drying ≤ 0.5% USP/EP Method Heavy Metals (as Pb) ≤ 10 ppm ICP-MS Related Substances Individual ≤ 0.1%, Total ≤ 0.2% HPLC These parameters are rigorously tested to meet or exceed pharmacopoeial standards such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia), ensuring product quality and safety for critical applications. Manufacturing Process Flow The production of high-grade S-(Carboxymethyl)-L-cysteine involves a meticulously controlled multi-step synthesis and purification process. This ensures exceptional purity, stability, and compliance with the most stringent global pharmaceutical standards. Our process emphasizes the use of high-quality starting materials and advanced manufacturing techniques. Schematic Steps of S-(Carboxymethyl)-L-cysteine Synthesis: Raw Material Sourcing: Selection of pharmaceutical-grade L-cysteine and chloroacetic acid as primary reactants. Strict vendor qualification and incoming material inspection are critical. Reaction (Carboxymethylation): L-cysteine is reacted with chloroacetic acid under controlled alkaline conditions. This alkylation reaction attaches the carboxymethyl group to the sulfhydryl group of cysteine. Parameters like temperature, pH, and reaction time are precisely monitored in ISO-certified reactors to optimize yield and minimize by-product formation. Purification & Crystallization: Following the reaction, the crude product undergoes a series of purification steps, including activated carbon treatment and recrystallization from appropriate solvent systems. This stage is crucial for removing impurities and achieving the desired purity profile. Drying: The purified product is then carefully dried using methods like vacuum drying or fluid bed drying to achieve the specified moisture content, preventing degradation and ensuring long-term stability. Milling & Sieving: The dried material is milled to a uniform particle size distribution, essential for subsequent formulation processing, and then sieved to remove any oversized particles, adhering to strict particulate contamination standards. Quality Control Testing: Comprehensive testing is conducted at every stage and on the final product. This includes assay, purity (HPLC), heavy metals (ICP-MS), specific optical rotation, loss on drying, microbial limits, and residual solvents. Testing standards comply with USP, EP, and internal stringent specifications. Our facilities adhere to ISO 9001 and GMP guidelines, ensuring consistent quality and batch-to-batch reproducibility. Packaging: The final product is packaged in pharmaceutical-grade, airtight container111s under controlled environmental conditions (e.g., nitrogen purged) to protect against moisture and contamination, ensuring a long service life and stability of typically 2-3 years when stored as per recommendations. This rigorous process flow is designed not only for product quality but also for operational efficiency, reflecting advantages such as energy saving through optimized reaction conditions and corrosion resistance of specialized equipment in petrochemical and fine chemical synthesis environments. Application Scenarios The versatility of S-(Carboxymethyl)-L-cysteine extends across multiple high-value industries: Pharmaceutical Industry: Primarily utilized as a potent mucolytic agent. It reduces the viscosity of bronchial secretions, facilitating easier expectoration in conditions like bronchitis, emphysema, and other chronic obstructive pulmonary diseases (COPD). It is a key active ingredient in many cough and cold preparations. Nutraceuticals & Dietary Supplements: Valued for its antioxidant properties and as a precursor to glutathione, a powerful endogenous antioxidant. It supports immune function, aids detoxification pathways, and is used in supplements targeting respiratory health and liver support. Cosmetics & Personal Care: Incorporated into hair care products to strengthen hair shafts and improve texture, as well as in skin creams for its potential antioxidant effects and role in maintaining skin integrity. Its ability to supply sulfur is beneficial for keratin formation. Veterinary Medicine: Used in animal health products, particularly for respiratory conditions in livestock and pets, mirroring its application in human pharmaceuticals. In typical application scenarios, such as pharmaceutical formulation, our cas 638 23 3 ensures superior dissolution profiles and excellent content uniformity due to its consistent particle size and high purity, which translates to optimal therapeutic outcomes for patients. Technical Advantages and Performance Our S-(Carboxymethyl)-L-cysteine offers distinct technical advantages critical for high-stakes B2B applications: Exceptional Purity Profile: Achieves an assay of 98.5% to 101.5%, with stringent control over related substances and impurities, ensuring maximum efficacy and minimizing potential side effects. This high purity is critical for compliance with global pharmacopoeial standards (e.g., USP, EP, JP). Optimal Stability: Engineered for superior chemical stability, translating to extended shelf life for finished products and robust performance under varying storage and environmental conditions. Our stability data supports a shelf life of at least 2-3 years, a crucial factor for pharmaceutical logistics. Consistent Particle Size Distribution: Our controlled milling and sieving processes yield a consistent particle size, which is vital for formulation homogeneity, dissolution rates, and manufacturability in solid dosage forms (e.g., tablets, capsules) and liquid suspensions. This uniformity leads to reproducible product quality. Regulatory Compliance: Manufactured under strict GMP (Good Manufacturing Practices) and ISO 9001 certified conditions, providing comprehensive documentation (e.g., CoA, MSDS, TSE/BSE statements) to facilitate regulatory filings and approvals for our clients worldwide. Excellent Solubility: High water solubility ensures ease of formulation into various dosage forms, including syrups, oral solutions, and injectables, without the need for complex excipient systems. These technical attributes translate into reduced development time, lower formulation costs, and increased confidence in the final product's performance and safety for our clients in the pharmaceutical, cosmetic, and nutraceutical industries. Vendor Comparison and Selection Criteria Selecting a reliable supplier for pharmaceutical ingredients like S-(Carboxymethyl)-L-cysteine is paramount. Key criteria extend beyond price and immediate availability to encompass long-term partnership value and risk mitigation. Vendor Comparison Factors for Pharmaceutical Ingredients Factor Typical Vendor Offerings Our Commitment Product Purity & Consistency Variable, sometimes minimal documentation. Minimum 98.5% assay, comprehensive CoA, batch-to-batch consistency guaranteed by ISO 9001 and GMP. Regulatory Support Basic MSDS, limited certifications. Full documentation package (CoA, MSDS, GMP, ISO, TSE/BSE, Allergens, Residual Solvents) to support global regulatory filings. Supply Chain Reliability Potential for disruptions, long lead times. Robust supply chain management, buffer stock, transparent lead times (typically 2-4 weeks), and contingency planning. Technical Support & Customization Limited or generic support. Dedicated technical team, R&D capabilities for custom synthesis, and adaptable packaging options. Auditing & Transparency Reluctance to allow customer audits. Open to customer audits, full transparency regarding manufacturing processes and quality systems. Choosing a vendor for S-(Carboxymethyl)-L-cysteine requires a holistic approach, focusing on long-term value, quality assurance, and a partnership built on trust and mutual growth. Our adherence to these principles positions us as a preferred supplier. Customized Solutions We understand that B2B clients often have unique requirements for their specific applications. Our capabilities extend to providing customized solutions for S-(Carboxymethyl)-L-cysteine , addressing particular formulation challenges or specialized market needs. Particle Size Optimization: Tailored milling to achieve specific particle size distributions (e.g., micronized grades for enhanced dissolution or larger particles for improved flowability) depending on the end-use application, such as tableting or suspension formulation. Custom Packaging: Offering a range of packaging options from bulk drums to smaller, specific-weight container111s, designed to integrate seamlessly into client production lines and maintain product integrity under various logistical demands. Enhanced Purity Grades: For highly sensitive applications, we can offer further purification steps to achieve even stricter impurity profiles, exceeding standard pharmacopoeial requirements. Formulation Support: Our technical team can provide expertise and data to assist clients in optimizing their formulations, troubleshooting stability issues, or improving manufacturing processes involving 638 23 3 . This bespoke approach ensures that our clients receive a product perfectly suited to their manufacturing processes and specific market demands, leading to optimized product performance and faster market entry. Application Case Studies Case Study 1: Oral Mucolytic Syrup for Chronic Bronchitis A leading pharmaceutical client sought a high-purity S-(Carboxymethyl)-L-cysteine with enhanced solubility and neutral taste profile for a new oral mucolytic syrup targeting chronic bronchitis patients. Our standard product met the purity and solubility requirements. However, to address the taste masking challenge inherent with cysteine derivatives, we collaborated to provide a specific micronized grade that allowed for more effective coating technologies and reduced overall API concentration required per dose while maintaining efficacy. The resulting product demonstrated superior patient compliance in clinical trials due to improved palatability, leading to a successful market launch and rapid adoption. Case Study 2: Anti-Pollution Skincare Serum A major cosmetic brand aimed to develop an advanced anti-pollution serum leveraging potent antioxidants. They required cas 638 23 3 with extremely low heavy metal content and exceptional stability in aqueous formulations. Our analytical team performed extensive stability studies on their prototype formulations, providing data on degradation kinetics and recommending optimal storage conditions. We supplied a custom batch of S-(Carboxymethyl)-L-cysteine rigorously tested to meet their ultra-low heavy metal specifications (<5 ppm), significantly below pharmacopoeial limits. This enabled the client to achieve a premium product positioning with strong consumer confidence in its safety and efficacy. Customer feedback highlighted the serum's superior antioxidant performance and skin protection benefits. Frequently Asked Questions (FAQ) Q1: What is the shelf life of S-(Carboxymethyl)-L-cysteine? A1: When stored in original, unopened packaging under recommended conditions (cool, dry place, protected from light), S-(Carboxymethyl)-L-cysteine typically has a shelf life of 2-3 years. Batch-specific Certificates of Analysis (CoA) provide exact retest dates. Q2: What quality standards do you comply with for 638 23 3? A2: Our cas 638 23 3 is manufactured under strict GMP (Good Manufacturing Practices) guidelines and our facility is ISO 9001 certified. The product meets or exceeds the specifications of major pharmacopoeias, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia). Q3: Can you provide samples for R&D purposes? A3: Yes, we provide samples of S-(Carboxymethyl)-L-cysteine for research and development evaluation. Please contact our sales team with your specific requirements. Q4: What is the typical lead time for bulk orders? A4: Standard lead time for bulk orders is typically 2-4 weeks, depending on order size and current stock levels. We recommend discussing specific lead times with your account manager for critical orders. Lead Time, Warranty, and Customer Support Lead Time & Fulfillment We maintain efficient production schedules and robust inventory management to ensure timely fulfillment. For most standard orders of S-(Carboxymethyl)-L-cysteine , our lead time is between 2 to 4 weeks from order confirmation to dispatch. Urgent requests and large-volume contracts can be negotiated to meet specific project timelines, supported by our flexible production capacity and reliable logistics network. Warranty Commitments Our cas 638 23 3 comes with a comprehensive warranty against defects in materials and manufacturing. We guarantee that the product will meet the specifications outlined in its Certificate of Analysis and adhere to all applicable pharmacopoeial standards at the time of delivery and for the duration of its stated shelf life, provided it is stored and handled according to our recommendations. Any deviation from these standards will be addressed promptly through our quality assurance process, including replacement or credit. Dedicated Customer Support Our commitment extends beyond product delivery. We offer dedicated customer support, including technical assistance, regulatory documentation support, and logistics coordination. Our team of experienced technical professionals is available to address any inquiries related to product application, formulation, or quality. We pride ourselves on responsive communication and building lasting partnerships. Contact us for detailed product inquiries, sample requests, or to discuss your specific project needs. Our aim is to be a reliable and valued partner in your supply chain. Conclusion As a critical pharmaceutical and nutraceutical ingredient, S-(Carboxymethyl)-L-cysteine plays a vital role in advancing respiratory health, skin care, and overall well-being. Our unwavering commitment to quality, backed by rigorous manufacturing processes, extensive testing, and adherence to global regulatory standards, ensures that our product stands at the forefront of the industry. By partnering with us, B2B clients gain access to a superior ingredient and a trusted supplier dedicated to excellence, innovation, and customer success. References United States Pharmacopeial Convention. (2023). USP Monographs for S-Carboxymethylcysteine. European Directorate for the Quality of Medicines & HealthCare (EDQM). (2023). European Pharmacopoeia Monographs for S-Carboxymethylcysteine. Wang, J., & Guo, W. (2022). Advances in L-Cysteine Derivatives and Their Biomedical Applications. Journal of Medicinal Chemistry, 65(18), 11987-12003. Global Respiratory Drugs Market Size, Share & Trends Analysis Report. (Various market research reports, e.g., Grand View Research, Fortune Business Insights). Food and Drug Administration. (2023). CFR Title 21 - Food and Drugs.