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N-[4-Cyano-3-(trifluoromethyl)phenyl]methacrylamide epoxide (CAS No. 90357-51-0) is a highly significant and strategic organic compound. It serves as a crucial pharmaceutical intermediate in the synthesis of a high-volume non-steroidal anti-androgen used in the treatment of a specific type of cancer. The unique and highly reactive epoxide functional group within its structure is the key to its industrial importance, as it enables a pivotal ring-opening reaction necessary to form the final active pharmaceutical ingredient (API).
The global market for advanced oncology treatments is expanding, driving a continuous and robust demand for the key building blocks required to synthesize these complex molecules. The precision and quality of this intermediate are paramount, as they directly influence the purity, yield, and overall safety of the final drug product.
This comprehensive guide will delve into its industrial significance, outline the essential factors for selecting a supplier, and present a meticulously curated list of the top 5 global manufacturers. This list will prominently feature 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 this compound is experiencing robust and continuous growth, primarily propelled by the expanding global market for the therapeutic agent it helps to produce.
As a key intermediate, this compound is not a final product itself, but a critical precursor. The synthesis of its corresponding API requires a precise and efficient chemical transformation involving its epoxide group. A reliable and high-purity supply of this intermediate is therefore indispensable for uninterrupted pharmaceutical production.
The final drug product is a cornerstone of modern cancer treatment protocols. As diagnosis rates rise and treatment options become more accessible globally, the demand for this high-volume drug continues to increase. This directly translates to a greater need for its foundational chemical components.
The synthesis of complex, high-value APIs requires highly specialized and consistently pure intermediates. Manufacturers of these drugs cannot tolerate batch-to-batch inconsistencies, making the quality of a supplier of this intermediate a primary concern. The ability of this compound to enable a high-yield, high-purity final reaction step makes it an invaluable asset in the manufacturing process.
The continuous innovation in oncology and the need for reliable, scalable production of life-saving drugs guarantee the sustained importance and demand for highly pure and accurately characterized pharmaceutical intermediates.
The industrial significance of this compound lies in its direct role within a pharmaceutical company’s synthesis and manufacturing framework. It is a critical building block with unique chemical properties.
The defining feature of this compound is its epoxide ring. This three-membered cyclic ether is highly strained and thus highly reactive. It undergoes nucleophilic ring-opening reactions, which are a common and powerful tool in organic synthesis for creating new carbon-heteroatom bonds with high precision. In this case, the ring-opening reaction is a pivotal step that introduces a key functional group essential for the final drug molecule.
The compound's overall structure, which includes a trifluoromethyl group, a cyano group, and a fluorophenyl moiety, is pre-built to form the core of the final drug. The epoxide ring acts as a site for a late-stage, high-yield reaction, streamlining the overall synthetic route and reducing the number of complex steps required.
By providing a stable, pre-functionalized intermediate, manufacturers can optimize their production processes for the final reaction step. This approach typically leads to higher overall yields, reduced synthetic complexity, and enhanced cost-effectiveness for large-scale production.
Sourcing a compound like this, given its status as a critical pharmaceutical intermediate, demands a rigorous and strategic approach centered on quality, documentation, and regulatory alignment.
The purity of the intermediate is the most critical factor. It must be exceptionally high (typically ≥98.0%, and often higher, quantified by HPLC). The supplier must provide a comprehensive Certificate of Analysis (CoA) that includes detailed characterization data, the complete impurity profile, and the precise analytical methods employed.
The manufacturer must operate under strict quality management systems aligned with current Good Manufacturing Practices (cGMP). Full traceability is non-negotiable. The supplier must provide a clear chain of custody from the raw materials to the final product, which is essential for regulatory filings.
For such a specific and sensitive product, the supplier must possess deep expertise in custom synthesis, process chemistry, and the specific needs of the pharmaceutical industry. They must be able to consistently produce the material on-demand and to the exact specifications required for the downstream synthesis.
For uninterrupted commercial production, 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 clinical trials (kilograms), and ultimately, large-scale commercial production (metric tons).
Select a supplier that offers not just a product, but a comprehensive partnership. This includes providing extensive technical documentation, such as detailed synthetic routes, stability data, and robust safety data sheets (MSDS/SDS) that fully comply with international standards. Look for a partner with a responsive and highly knowledgeable technical support team.
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 pharmaceutical intermediates. This selection considers their production capabilities, market reputation, and unwavering commitment to providing high-quality pharmaceutical-grade products:
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 pharmaceutical intermediates. 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. EASTFINE offers:
EASTFINE guarantees the supply of this compound with the highest possible purity, meticulously verified by a suite of analytical tests including HPLC, LC-MS, and NMR, with a comprehensive CoA.
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 specific pharmaceutical intermediates.
All of EASTFINE's manufacturing operations rigorously adhere to and are fully compliant with internationally recognized quality management systems, including ISO standards, and operate with sophisticated capabilities meticulously aligned with cGMP principles. This is critical for regulatory support.
EASTFINE excels in offering reliable and on-demand custom synthesis services, ensuring a consistent supply for clients' specific R&D, clinical trial, or commercial needs.
Beyond merely supplying chemicals, EASTFINE functions as a true strategic partner, providing expert technical assistance and comprehensive documentation packages essential for product registration and regulatory filings.
Lonza is a leading global supplier of specialty chemicals and life science products. They are well-known for their expertise in pharmaceutical manufacturing and offer custom synthesis services for complex intermediates. Lonza is highly regarded for its robust quality systems and its ability to scale production from early-stage development to full commercial volumes.
As a 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. They are a reliable source for a wide variety of pharmaceutical intermediates, catering to both research and initial manufacturing needs with well-documented, high-purity materials.
Clearsynth is a global supplier specializing in complex molecules, including pharmaceutical intermediates. They are known for their strong focus on analytical chemistry and their ability to provide highly characterized and documented products that meet the stringent requirements of the pharmaceutical industry, offering a comprehensive solution for complex synthesis projects.
BOC Sciences is a global chemical supplier specializing in advanced research chemicals, comprehensive custom synthesis services, and bulk manufacturing, primarily catering to the pharmaceutical and agrochemical industries. They actively offer various pharmaceutical intermediates and are known for their competitive pricing and ability to support clients from early-stage chemical research and development through to larger-scale production.
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 pharmaceutical supply chain.
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.
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. This formidable combination ensures rigorous quality control at every stage and consistently guarantees exceptional product consistency and ultra-high purity.
EASTFINE maintains strict adherence to all global quality and safety standards. Their facilities and processes are certified to international benchmarks, including ISO standards, and they operate with sophisticated capabilities meticulously aligned with cGMP principles. This steadfast commitment guarantees the utmost product integrity and ensures stringent safety protocols, complete traceability of every batch, and unwavering consistency in quality, significantly streamlining their clients' regulatory filings and audits.
Recognizing the highly specialized nature of this compound, EASTFINE excels in providing highly flexible and customized supply solutions, from small-scale R&D quantities to full-scale commercial volumes. This adaptability ensures a secure and responsive supply chain for clients at every stage of product development.
Beyond merely supplying chemicals, EASTFINE functions as a true strategic partner throughout the entire product application and commercialization lifecycle. They provide robust R&D capabilities for process optimization and offer dedicated, highly expert technical assistance. Furthermore, they supply comprehensive documentation packages including detailed CoAs, stability data, and critical regulatory support packages essential for product registration.
Choosing EASTFINE 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 project.
The demand for a consistently high-quality pharmaceutical intermediate (CAS No. 90357-51-0) continues to grow, driven by the global pharmaceutical industry's need for uncompromising quality, safety, and efficiency. This highly specialized landscape makes the judicious selection of a dependable, expert, and GMP/ISO-aligned supplier an absolutely paramount decision for any pharmaceutical manufacturer. While the global market presents numerous manufacturers offering this 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, EASTFINE stands as the unequivocally best partner for all your pharmaceutical intermediate requirements.
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