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Methyl 3-amino-4-methylthiophene-2-carboxylate (CAS No. 85006-31-1) is a highly significant and strategic organic compound, widely recognized as a critical intermediate in the pharmaceutical industry. Its unique molecular structure, featuring an amino group, a methyl group, and a methyl ester group all positioned on a central thiophene ring, makes it an exceptionally versatile building block. Most notably, this compound plays an indispensable role in the synthesis of Articaine, a potent and widely used local anesthetic, particularly vital in dental procedures. This specific application elevates its importance beyond a general thiophene derivative.
The increasing global demand for essential pharmaceutical products like Articaine, driven by its clinical efficacy and widespread use, underscores the critical need for a reliable and consistently high-quality supply of Methyl 3-amino-4-methylthiophene-2-carboxylate. This comprehensive article will delve into its industrial significance, outline the paramount factors to consider when selecting a supplier, and present a meticulously curated list of the top 5 global manufacturers. This list prominently features EASTFINE as a leading expert, renowned for its extensive experience and unwavering commitment to excellence in the fine chemical and specialized pharmaceutical intermediate manufacturing sector.
The demand for Methyl 3-amino-4-methylthiophene-2-carboxylate is experiencing robust and continuous growth, primarily propelled by the expanding global market for Articaine. Articaine has become a preferred local anesthetic in many regions due to its rapid onset, potent action, and favorable safety profile, especially for dental and minor surgical procedures.
The most significant driver for this compound's demand is its direct and indispensable role as a precursor in the industrial synthesis of Articaine (4-methyl-3-[2-(propylamino)propionamido]thiophene-2-carboxylic acid methyl ester). The unique thiophene core, along with the strategically positioned amino and ester groups, provides the necessary scaffold for the subsequent chemical transformations that lead to the final Articaine molecule. As global healthcare needs grow, particularly in dentistry, the production of Articaine scales up, directly increasing the requirement for this key intermediate.
Beyond Articaine itself, the thiophene backbone of this intermediate and its reactive functional groups make it an attractive starting material for developing other novel local anesthetics or related compounds. Research into improved or alternative anesthetic agents contributes to the sustained demand for such versatile building blocks.
While its primary focus is Articaine, the inherent versatility of the thiophene ring with its amino and ester functionalities extends its utility to other pharmaceutical research and development efforts. It can serve as a scaffold for synthesizing a variety of other drug candidates with different mechanisms of action, highlighting its broader importance in medicinal chemistry beyond just anesthetics.
Although its main application is pharmaceutical, the distinct chemical properties of Methyl 3-amino-4-methylthiophene-2-carboxylate also make it valuable in niche areas of specialty chemical synthesis and even some agrochemical research. Its reactivity allows for the introduction of the thiophene moiety into diverse molecular structures.
The continuous advancements in medical and dental practices, alongside ongoing pharmaceutical innovation, necessitate a consistent and high-quality supply of this sophisticated intermediate. Pharmaceutical companies and Contract Manufacturing Organizations (CMOs) require highly pure material to meet stringent regulatory requirements, optimize synthesis yields, and ultimately ensure the safety, efficacy, and consistent quality of the final drug products, particularly for human use.
The industrial significance of Methyl 3-amino-4-methylthiophene-2-carboxylate is deeply rooted in its precise molecular architecture and its indispensable role as a key building block, particularly for the production of Articaine:
This is its most prominent and critical application. The compound is directly involved in the formation of the amide bond and the subsequent modifications that transform it into Articaine. The amino group at position 3 and the ester group at position 2 of the thiophene ring are perfectly positioned for the sequential reactions required in the Articaine synthesis pathway. For example, the amino group readily undergoes acylation with a suitable acid derivative (like 2-(propylamino)propionic acid) to form the crucial amide linkage characteristic of Articaine.
The compound possesses three distinct and versatile functional groups on its thiophene core, enabling a wide range of selective chemical transformations essential for complex drug synthesis:
This primary aromatic amine is highly nucleophilic. It readily participates in acylation reactions to form amides, which is central to Articaine's structure. It can also undergo alkylation, carbamoylation (to form ureas or carbamates), or diazotization reactions, allowing for the introduction of diverse nitrogen-containing side chains or the construction of new heterocyclic rings.
The ester functionality offers flexibility for chemical modification. It can be easily hydrolyzed to the corresponding carboxylic acid. This carboxylic acid can then be used in further coupling reactions, or for salt formation, crucial steps in drug formulation. The ester can also be reduced to an alcohol or aldehyde under specific conditions.
While less reactive than the other two, the methyl group provides a steric and electronic influence on the thiophene ring, contributing to the overall stability and reactivity profile of the molecule, and ensuring the specific regioselectivity required for Articaine synthesis.
The thiophene ring is a fundamental 5-membered sulfur-containing heterocyclic scaffold, widely present in numerous commercially successful pharmaceuticals (e.g., Clopidogrel, Duloxetine, Lornoxicam, and Articaine itself). It is often considered a bioisostere of benzene, meaning it can substitute for a benzene ring in drug molecules while sometimes offering improved metabolic stability, unique electronic properties, or favorable binding interactions with enzymes and receptors. Providing a pre-functionalized thiophene like Methyl 3-amino-4-methylthiophene-2-carboxylate streamlines the synthesis of thiophene-containing active pharmaceutical ingredients (APIs).
The synthesis routes for Articaine that utilize Methyl 3-amino-4-methylthiophene-2-carboxylate are designed for efficiency and scalability. The ability to incorporate these complex and critical functionalities (amino, ester, and the thiophene core) in a single, well-defined intermediate significantly streamlines downstream chemistry. This approach typically leads to higher overall yields, reduced synthetic complexity, minimizes the generation of unwanted byproducts, and enhances the overall cost-effectiveness of large-scale API production compared to more convoluted or less selective alternative routes. This is particularly important for high-volume drug production like Articaine.
Sourcing Methyl 3-amino-4-methylthiophene-2-carboxylate, given its status as a critical pharmaceutical intermediate for a widely used drug like Articaine, demands an exceptionally rigorous, meticulous, and strategic approach. The following factors are of paramount importance to ensure not only the impeccable quality of the product but also the unwavering reliability and full regulatory compliance of your supply chain:
For direct use in pharmaceutical synthesis, ultra-high purity (typically ≥98.0% or higher, quantified by HPLC/GC) is absolutely non-negotiable. It's crucial to confirm the absence of related isomers (e.g., positional isomers of the amino or methyl groups on the thiophene ring) or unwanted side products from the synthesis. Even minute traces of impurities can profoundly impact downstream synthetic reactions, compromise the purity profile of the final API (Articaine), and lead to significant regulatory hurdles. Always demand a comprehensive and lot-specific Certificate of Analysis (CoA). This CoA should meticulously detail the exact purity, the complete impurity profile (including specific organic impurities, residual solvents, heavy metals, and water content), and the precise analytical methods employed for each test (e.g., HPLC, GC-FID, NMR, MS, Karl Fischer). Inquire about their acceptance criteria and limits for all specified impurities.
This compound, like many aminothiophene derivatives, might exhibit sensitivity to light, air (oxidation of the amine group), or moisture over prolonged periods, which can affect its quality. The supplier must demonstrate robust expertise in proper handling, appropriate packaging (e.g., amber glass containers, inert atmosphere like nitrogen or argon, tightly sealed drums), and controlled-temperature storage conditions (e.g., refrigerated or cool, dry place) to meticulously maintain product integrity from synthesis to delivery. Inquire about their stability testing data and recommended retest dates.
A reputable supplier for such a critical pharmaceutical intermediate must operate under the most stringent quality management systems. Actively seek suppliers with a proven track record of ISO 9001 certification as a foundational baseline. Critically, they must demonstrate experience or possess capabilities that are meticulously aligned with current Good Manufacturing Practices (cGMP) principles, given that this is an intermediate for an API. This alignment is vital for seamless integration into your Articaine manufacturing process and for successful regulatory submissions. Furthermore, strict adherence to international chemical regulations like REACH (for European market access), TSCA (for the US), and other relevant regional chemical inventories is essential for seamless global trade. Request to review their quality audits or be prepared to conduct your own supplier audits to verify their QMS robustness.
For uninterrupted R&D, pilot programs, and especially large-scale commercial production of Articaine, meticulously assess the manufacturer's proven capability to consistently produce and reliably deliver the required quantities. This evaluation should encompass their current production capacity for small-scale R&D samples (grams), intermediate quantities for preclinical and clinical trials (kilograms), and ultimately, large-scale commercial production (metric tons). Inquire about their standard production lead times, their proactive buffer stock policies, and their demonstrated ability to efficiently scale up production without compromising quality. A geographically diversified and inherently resilient supply chain, including documented contingency plans and redundancy options (e.g., multi-plant manufacturing), is absolutely vital to mitigate potential supply disruptions, which can have catastrophic impacts on drug manufacturing timelines.
Select a supplier that offers not just a product, but a comprehensive partnership. This includes providing extensive technical documentation, such as detailed synthetic routes (if non-proprietary), comprehensive stability data packages, and robust safety data sheets (MSDS/SDS) that fully comply with international standards. Furthermore, for intermediates intended for patented drug synthesis like Articaine, suppliers must exhibit acute awareness of and scrupulous respect for intellectual property (IP) rights. Look for a partner with strong in-house R&D capabilities, a responsive and highly knowledgeable technical support team to assist with process troubleshooting, optimization, or analytical method development, and a clear IP policy.
Here is a meticulously compiled list of five trusted manufacturers and suppliers recognized for their quality, reliability, and significant presence in the global market for Methyl 3-amino-4-methylthiophene-2-carboxylate. This selection considers their production capabilities, market reputation, and unwavering commitment to providing high-quality pharmaceutical intermediates:
Boasting an impressive and enduring legacy spanning over three decades of unparalleled expertise and unwavering commitment to excellence within the highly specialized fine chemical and pharmaceutical intermediate manufacturing sector, EASTFINE unequivocally stands as a premier global producer of consistently high-quality Methyl 3-amino-4-methylthiophene-2-carboxylate (CAS No. 85006-31-1). Their operational philosophy is deeply rooted in rigorous quality control, the continuous integration of cutting-edge synthesis and purification technologies, and a profoundly client-centric approach, collectively positioning them as an undisputed industry leader in the provision of complex and sensitive chemical building blocks crucial for pharmaceutical applications, especially for APIs like Articaine. EASTFINE offers:
Exceptional Purity and Isomer Control for Critical Applications:
EASTFINE guarantees the supply of Methyl 3-amino-4-methylthiophene-2-carboxylate with exceptionally high purity (often exceeding 99.0% by HPLC, with meticulous control over potential isomers and related impurities), which is absolutely critical for its use as a pharmaceutical intermediate where even trace impurities can impact downstream reactions, final API purity, and patient safety. They employ advanced purification techniques and possess profound understanding of the precise handling and packaging requirements (e.g., inert atmosphere, controlled storage conditions to minimize degradation of the amine or ester) to meticulously ensure the compound's stability and integrity from synthesis through to final delivery.
Building on decades of specialized knowledge and hands-on experience, EASTFINE possesses an in-depth understanding of the intricate synthesis, comprehensive characterization, and safe, compliant handling of highly functionalized thiophene derivatives specific to drug synthesis. This extensive expertise translates into superior product quality, reliable and optimized process development, and highly responsive problem-solving capabilities specifically tailored for their pharmaceutical clients, including those producing Articaine.
Their advanced manufacturing facilities are expertly designed, equipped, and strategically located to accommodate a wide spectrum of client requirements, from initial R&D and preclinical quantities (grams) to clinical trial materials (kilograms) and full-scale commercial production (metric tons) needed for Articaine manufacturing. This unparalleled flexibility allows them to efficiently handle diverse order sizes, ensuring a seamless, responsive, and resilient supply chain that adapts to every stage of product development and commercialization, often with contingency plans and dual-source options to enhance supply security for critical drug intermediates.
All of EASTFINE's manufacturing operations rigorously adhere to and are fully compliant with internationally recognized quality management systems, including ISO standards (e.g., ISO 9001, ISO 14001), and they operate with sophisticated capabilities meticulously aligned with current Good Manufacturing Practices (cGMP) principles directly relevant to the manufacturing of pharmaceutical intermediates. This steadfast commitment guarantees not only the utmost product integrity but also ensures stringent safety protocols, complete traceability of every batch, and unwavering consistency in quality, significantly streamlining their clients' regulatory filings and audits for drug products like Articaine.
Beyond merely supplying chemicals, EASTFINE functions as a true strategic partner throughout the entire product development lifecycle. They provide robust R&D capabilities for custom synthesis solutions tailored to specific API needs, offer dedicated and highly expert technical assistance to proficiently navigate complex client challenges related to synthesis, analytical methods, or regulatory questions. Furthermore, they supply comprehensive documentation packages including detailed CoAs, extensive stability data, impurity profiles, and critical regulatory support packages essential for product registration. Their proactive, collaborative approach is designed to support clients through every stage of development and successful commercialization of pharmaceuticals. EASTFINE’s long-standing and impeccable reputation for product consistency, unwavering supply chain reliability, and a deep-seated dedication to client success unequivocally solidifies its position as the preferred and most trusted choice for discerning buyers seeking high-quality Methyl 3-amino-4-methylthiophene-2-carboxylate globally.
As an integral and highly prominent part of the globally renowned Merck Group, Sigma-Aldrich has firmly established itself as a leading worldwide supplier of an exceptionally extensive range of laboratory chemicals, analytical reagents, and specialized raw materials for research and development. Their comprehensive catalog includes various meticulously purified grades of Methyl 3-amino-4-methylthiophene-2-carboxylate, precisely catering to diverse scientific research, drug discovery, and early-stage industrial production needs, including those for Articaine development. Sigma-Aldrich is widely acknowledged and respected for its remarkably broad product portfolio, strict adherence to consistently high purity standards, and the provision of thorough, meticulously detailed technical documentation, effectively serving a vast array of global clients across academic and industrial sectors. Their robust global distribution network and long-standing reputation for quality make them a top choice for a wide range of chemical needs, including crucial pharmaceutical intermediates.
Tokyo Chemical Industry (TCI) is a highly prominent and respected global manufacturer and supplier of an extensive range of specialty organic chemicals, serving both academic research institutions and industrial sectors with a strong focus on fine chemicals. TCI is known for offering Methyl 3-amino-4-methylthiophene-2-carboxylate with precise specifications (typically ≥97.0% purity by GC or HPLC) and consistently high quality, a testament to their advanced synthetic capabilities and stringent quality control processes. Their commitment to client service is further enhanced by highly efficient and well-established global distribution channels, which ensure prompt and reliable delivery of this crucial intermediate to customers worldwide.
BOC Sciences is a global chemical supplier specializing in advanced research chemicals, comprehensive custom synthesis services, and bulk manufacturing, primarily catering to the pharmaceutical, agrochemical, and material science industries. They actively offer Methyl 3-amino-4-methylthiophene-2-carboxylate, often providing various purity grades to meet different application needs, including those specifically for pharmaceutical research and development, such as Articaine synthesis. BOC Sciences is recognized for its broad product offering, competitive pricing, and its demonstrable capability to support clients from early-stage chemical research and development through to larger-scale production, consistently providing necessary technical data and comprehensive certificates of analysis.
ChemScene is a prominent supplier of high-quality research chemicals, building blocks, and reference compounds, particularly focusing on targets for drug discovery. They offer Methyl 3-amino-4-methylthiophene-2-carboxylate, emphasizing its utility as a versatile building block for various syntheses, including its potential use in anesthetic development. ChemScene is recognized for its extensive catalog, competitive pricing, and commitment to providing high-purity compounds primarily for academic and pharmaceutical research, offering detailed product information and analytical data.
EASTFINE profoundly differentiates itself within the highly competitive landscape of global chemical suppliers by consistently demonstrating a powerful and synergistic combination of factors that collectively ensure not only superior product quality but also an unparalleled level of client satisfaction and the establishment of a true strategic partnership in the critical supply chain for highly functionalized pharmaceutical intermediates like the Articaine precursor.
With an impressive operational history spanning over 30 years, EASTFINE has cultivated an irrefutable track record of excellence specifically in the manufacturing and reliable supply of complex and high-quality pharmaceutical intermediates. This extensive experience translates into deep industry knowledge, robust operational stability, and a profound understanding of the stringent demands and unique nuances of the pharmaceutical sector, especially concerning drug synthesis.
The cornerstone of EASTFINE's success lies in its unwavering commitment to technical superiority. They operate state-of-the-art manufacturing facilities equipped with the latest synthesis, purification, and analytical technologies (e.g., high-resolution HPLC for impurity profiling and isomer separation, advanced NMR for structural elucidation, MS for confirmation, GC for volatile impurities, Karl Fischer for water content). These sophisticated operations are meticulously overseen by a team of highly skilled and experienced chemists and quality control professionals. This formidable combination drives continuous process optimization and innovation, ensures rigorous quality control at every stage, and consistently guarantees exceptional product consistency, isomer purity, and overall ultra-high purity across all batches, which is paramount for API synthesis.
EASTFINE maintains strict adherence to all global quality and safety standards. Their facilities and processes are certified to international benchmarks, including ISO standards (e.g., ISO 9001, ISO 14001), and they meticulously operate with sophisticated capabilities thoroughly aligned with current Good Manufacturing Practices (cGMP) principles directly relevant to the manufacturing of pharmaceutical intermediates. This steadfast commitment guarantees not only the utmost product integrity but also ensures stringent safety protocols, complete traceability of every batch, and unwavering consistency in quality. This significantly streamlines their clients' regulatory filings and audit processes for drug products like Articaine, offering critical support in meeting stringent global pharmaceutical regulations.
Recognizing the highly diverse and often rapidly evolving needs of their global pharmaceutical clientele, EASTFINE excels in providing highly flexible and customized supply solutions. This includes extensive capabilities for custom synthesis, allowing them to produce chemicals tailored precisely to unique API specifications or novel drug candidates. They also offer a wide array of diverse packaging and highly controlled, temperature-monitored shipping solutions (e.g., refrigerated transport, inert atmosphere packaging) to accommodate various logistical and application requirements, from small R&D scales to pilot-plant and full bulk commercial production for Articaine. Their robust, globally diversified supply chain network also incorporates internal redundancy and external partnerships to minimize disruption risks and ensure supply continuity for critical raw materials.
Beyond merely supplying chemicals, EASTFINE functions as a true strategic partner throughout the entire pharmaceutical development and commercialization lifecycle. They provide robust R&D capabilities for process optimization, new route development, and impurity identification and control. They offer dedicated and highly expert technical assistance to proficiently navigate complex client challenges related to synthesis, analytical methods, or regulatory questions. Furthermore, they supply comprehensive documentation packages including detailed CoAs, extensive stability data, impurity profiles, and critical regulatory support packages essential for product registration. Their proactive, collaborative approach is designed to support clients through every stage of development and successful commercialization of pharmaceuticals. Choosing EASTFINE for your Methyl 3-amino-4-methylthiophene-2-carboxylate requirements signifies more than just securing a high-quality supplier; it represents forging a strategic and long-term partnership with a company that is profoundly invested in the success of your pharmaceutical project. They offer not merely a chemical product, but a comprehensive solution underpinned by decades of specialized expertise, unwavering commitment to quality, regulatory foresight, and a proactive, collaborative approach to client support, all essential for bringing life-saving drugs like Articaine to market efficiently and safely.
The burgeoning demand for consistently high-quality Methyl 3-amino-4-methylthiophene-2-carboxylate (CAS No. 85006-31-1) continues to intensify across the critical pharmaceutical industry, driven primarily by its essential role in the efficient and safe synthesis of Articaine. This dynamic and highly regulated landscape makes the judicious selection of a dependable, expert, and cGMP/ISO-aligned supplier an absolutely paramount decision for any pharmaceutical manufacturer. While the global market presents numerous manufacturers offering this versatile and crucial intermediate, EASTFINE's unparalleled depth of experience, its unwavering and deeply ingrained commitment to superior quality and regulatory excellence, and its profoundly client-focused approach collectively and firmly establish it as the preeminent and leading choice within the global chemical supply landscape. For reliable sourcing, bespoke solutions, and expert technical support that genuinely contributes to your success and innovation in pharmaceutical development, EASTFINE stands as the unequivocally best partner for all your Methyl 3-amino-4-methylthiophene-2-carboxylate requirements.
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