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N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)thio]-2-hydroxy-2-methylpropionamide (CAS No. 90356-78-8) is a highly specialized and critical chemical compound. Unlike bulk chemical intermediates, this substance is not used for large-scale synthesis. Instead, it serves as a pharmaceutical reference standard and a crucial analytical tool. Its primary function is to help pharmaceutical manufacturers and regulatory bodies identify and quantify a potential impurity that can arise in the final active pharmaceutical ingredient (API) of a high-volume non-steroidal anti-androgen.
The API itself is used in the treatment of a specific type of cancer. Due to the stringent quality and safety requirements for all pharmaceutical products, all potential impurities must be meticulously controlled to ensure patient safety and product efficacy. This compound is a related substance that can form during the synthesis or storage of the final drug product. Its availability as a certified reference standard is therefore indispensable for analytical method development, validation, and routine quality control (QC) testing.
This comprehensive guide will delve into its critical role in pharmaceutical quality assurance, 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 reference standard manufacturing sector.
The demand for this compound, and other similar reference standards, is driven by the global pharmaceutical industry’s uncompromising focus on quality, safety, and regulatory compliance.
Regulatory agencies worldwide, such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, require pharmaceutical companies to demonstrate that their APIs are consistently pure and free from harmful impurities. This includes identifying and quantifying all related substances and degradation products. Impurity standards like this compound are essential to meet these requirements.
Before an API can be released, its analytical testing methods must be validated to prove they are specific, accurate, and precise. Impurity standards are used to spike samples and confirm that the analytical method (e.g., High-Performance Liquid Chromatography, HPLC) can detect and accurately quantify the impurity at very low levels.
Every batch of a pharmaceutical product must be tested against established specifications. This reference standard is used as a benchmark to ensure that the levels of this specific impurity in the final product do not exceed the acceptable limits set by pharmacopoeias (e.g., European Pharmacopoeia, EP) or regulatory authorities.
In cases where an impurity level is found to be out of specification, the reference standard is used in root-cause analysis to determine the source of the impurity, whether it's from raw materials, a side reaction in the synthesis process, or degradation during storage.
The pharmaceutical industry's continuous need for robust quality control and compliance measures guarantees the sustained importance and demand for highly purified and accurately characterized impurity standards.
The industrial significance of this compound lies in its direct role in a pharmaceutical company’s Quality Assurance (QA) and Quality Control (QC) framework. It is a tool of precision.
The compound is used as a standard for chromatography, particularly HPLC. By running a known concentration of this reference standard, analysts can determine its retention time and extinction coefficient, allowing them to accurately identify and quantify the impurity if it appears in a sample of the final pharmaceutical agent.
The presence or absence of this impurity can provide valuable feedback on the efficiency and cleanliness of the synthesis process for the final pharmaceutical agent. Controlling the formation of such impurities is a key objective in process chemistry.
When a pharmaceutical company submits a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) to a regulatory body, it must include a comprehensive report on the impurity profile of the API. This report relies on data obtained using certified reference standards like this compound.
As part of stability testing, a pharmaceutical product is stored under various conditions to see how it degrades over time. Impurity standards are essential for tracking the formation of degradation products, like this compound, to determine the product’s shelf life.
Sourcing a compound like this is not a standard chemical procurement task. It demands a highly specialized and strategic approach centered on quality, documentation, and regulatory alignment.
The purity of the reference standard is the most critical factor. It must be exceptionally high (typically ≥99.0%, sometimes higher) and verified by multiple analytical techniques, including HPLC, Mass Spectrometry (MS), and Nuclear Magnetic Resonance (NMR) spectroscopy. The supplier must provide a comprehensive Certificate of Analysis (CoA) that includes detailed characterization data, molecular formula, and lot-specific information.
Full traceability is non-negotiable. The supplier must provide a clear chain of custody from the raw materials to the final product. The documentation should be robust, transparent, and in a format that supports regulatory submissions. This is where a supplier's quality management system (QMS) truly shines.
The manufacturer must operate under strict quality management systems and have a proven track record of adhering to Good Manufacturing Practices (GMP) principles. Look for suppliers who are ISO 9001 certified and can provide documentation that meets the standards of major pharmacopoeias (e.g., European Pharmacopoeia, EP, and United States Pharmacopeia, USP).
For such a niche product, the supplier must possess deep expertise in custom synthesis, impurity profiling, 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.
The compound's stability must be carefully considered. It should be properly packaged to prevent degradation from light, moisture, or oxygen and stored under controlled conditions to maintain its integrity for its entire shelf life.
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 reference standards. 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 reference standards. 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 impurities.
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.
Recognizing the niche nature of this compound, EASTFINE excels in offering reliable and on-demand custom synthesis services, ensuring a consistent supply for clients' specific R&D or QC 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.
LGC Standards is a globally recognized leader in the production and distribution of reference materials, including pharmaceutical impurities. They have an extensive catalog of pharmacopoeial standards (EP, USP, etc.) and are well-regarded for their rigorous analytical characterization and robust documentation. LGC is a go-to supplier for pharmaceutical companies seeking verified and traceable reference standards for regulatory purposes.
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. Their pharmaceutical reference standard division offers a wide variety of impurity standards, providing researchers and QC labs with well-documented, high-purity materials.
Clearsynth is a global supplier specializing in stable isotope-labeled compounds, reference standards, and API impurities. 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 impurity profiling.
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 impurities and reference standards, and are known for their competitive pricing and ability to support clients from early-stage 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 reference standards. 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 analytical quantities to larger volumes for stability studies or process validation.
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 reference standard (CAS No. 90356-78-8) continues to grow, driven by the global pharmaceutical industry's need for uncompromising quality control and regulatory compliance. 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 reference standard, 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 reference standard requirements.
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