For professionals in the chemical and pharmaceutical industries, understanding the precise specifications of raw materials is fundamental to successful product development and manufacturing. Etodolac (CAS 41340-25-4) is a crucial active pharmaceutical ingredient (API) widely used for its anti-inflammatory and analgesic properties. Sourcing this compound requires a keen eye for detail, particularly concerning its chemical specifications. This guide aims to demystify these details for R&D scientists, product formulators, and procurement managers looking to buy Etodolac.

The primary specification for any chemical raw material, especially an API, is its purity. For Etodolac, a minimum assay of 99% is typically the standard for pharmaceutical applications. This high level of purity is vital because even minor impurities can affect the drug's efficacy, stability, and safety profile. Manufacturers like Ningbo Inno Pharmchem prioritize achieving and maintaining this high assay through rigorous quality control throughout their production processes. When inquiring about Etodolac, always ask for the guaranteed minimum assay percentage.

Beyond the overall assay, the profile of related substances and impurities is equally important. Regulatory bodies and pharmacopoeia standards (like USP, BP, EP) set strict limits on individual impurities and the total impurity content. For Etodolac, specifications will detail limits for 'any other single impurity' and 'total impurities.' Understanding these limits helps buyers assess the potential impact of by-products from the manufacturing process. A reputable supplier will provide detailed documentation on their impurity profiles and how they ensure these are within acceptable ranges. For example, specifications might list limits such as NMT 0.5% for any single impurity and NMT 2.0% for total impurities.

Another critical aspect of the specification sheet is the control of residual solvents. These are solvents used during the manufacturing process that, if not adequately removed, can pose health risks. Common residual solvents to monitor for Etodolac might include Toluene and Methanol, with defined maximum limits (e.g., NMT 0.089% for Toluene, NMT 0.1% for Methanol). Proper solvent control is indicative of advanced manufacturing techniques and a commitment to product safety.

Other key specifications include physical characteristics like 'Appearance' (e.g., White or Almost White Crystalline Powder), and chemical tests such as 'Identification' (often confirmed by IR spectrum), 'Chloride' content, 'Water' content (e.g., NMT 0.5%), and 'Residue on Ignition' (e.g., NMT 0.1%). Heavy Metals limits are also crucial, typically specified as NMT 10ppm. These parameters collectively define the quality and suitability of the Etodolac for its intended pharmaceutical use.

For businesses looking to purchase Etodolac, engaging with a knowledgeable manufacturer and supplier is key. They can provide comprehensive technical data sheets and answer specific questions regarding these specifications. By thoroughly understanding and verifying these details, procurement managers and R&D scientists can confidently select Etodolac that meets all necessary quality and regulatory requirements, ensuring the integrity of their pharmaceutical products. Whether you are looking for an Etodolac manufacturer in China or a reliable global supplier, paying close attention to these specifications is the first step towards a successful partnership.