In the pharmaceutical industry, the quality of every component, from the final Active Pharmaceutical Ingredient (API) down to the raw materials and intermediates, is rigorously scrutinized. For the synthesis of Febuxostat, a vital medication for managing gout, the intermediate Ethyl 2-(3-cyano-4-hydroxyphenyl)-4-methylthiazole-5-carboxylate (CAS: 161798-02-3) is no exception. Ensuring its quality is not just a regulatory requirement but a fundamental aspect of producing a safe and effective drug.

The Critical Role of Purity for CAS 161798-02-3

As a manufacturer of this key intermediate, NINGBO INNO PHARMCHEM CO.,LTD. places immense emphasis on quality control. The purity of Ethyl 2-(3-cyano-4-hydroxyphenyl)-4-methylthiazole-5-carboxylate directly impacts the success of downstream synthesis steps for Febuxostat. Impurities, even in trace amounts, can lead to:

  • Reduced yield in the final API synthesis.
  • Formation of unwanted by-products that are difficult to remove.
  • Potential safety concerns if certain impurities carry over into the final drug product.
  • Challenges in meeting regulatory standards.

Therefore, manufacturers rigorously test for purity using advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC). The typical specification for this intermediate is often stated as ≥99% purity, with strict limits on individual impurities.

Key Quality Control Parameters for Manufacturers

When you buy Ethyl 2-(3-cyano-4-hydroxyphenyl)-4-methylthiazole-5-carboxylate from a reputable supplier, you can expect meticulous attention to several quality parameters:

  • Appearance: Typically specified as an off-white solid, any deviation might indicate contamination or degradation.
  • Melting Point: A sharp melting point within the specified range (208-210°C) is an indicator of purity.
  • Water Content (Moisture): Controlled to prevent unwanted side reactions during storage or further processing.
  • Residue on Ignition: Measures inorganic impurities.
  • Identification Tests: Spectroscopic methods like NMR and IR are used to confirm the chemical structure.

Partnering for Quality Assurance

As a dedicated Febuxostat intermediate manufacturer, we integrate quality control throughout our entire production process, from raw material sourcing to final product packaging. Our commitment is to provide pharmaceutical companies with an intermediate they can trust. If you are seeking a reliable CAS 161798-02-3 supplier, we invite you to contact us to learn more about our quality assurance protocols and to discuss how we can meet your specific needs for this critical pharmaceutical component.

Prioritizing quality in the sourcing of intermediates is not just about compliance; it’s about ensuring the efficacy, safety, and consistency of the final pharmaceutical product, ultimately benefiting the patients who rely on them.