The pharmaceutical industry demands exacting standards for every component used in drug synthesis. For Ethyl 3-[[3-amino-4-(methylamino)benzoyl]-pyridin-2-ylamino]propanoate (CAS 212322-56-0), a critical intermediate for Dabigatran etexilate, adherence to precise specifications is non-negotiable. Manufacturers must ensure their product consistently meets these benchmarks to facilitate smooth and successful downstream processes.

The appearance of the compound is typically described as a white or pale yellow crystalline solid. This physical characteristic is a primary visual indicator of product quality and consistency. Beyond appearance, purity is the most crucial specification. A minimum purity of ≥98.0%, confirmed by analytical methods like HPLC, is standard. This high purity level minimizes interference and side reactions during complex synthesis pathways, a key concern for R&D scientists.

Impurity profiling is equally vital. Manufacturers must control single impurities to ≤0.5% and total impurities to ≤1.0%. These stringent limits are essential for ensuring the safety and efficacy of the final Active Pharmaceutical Ingredient (API). Parameters such as residue on ignition (≤0.5%) and moisture content (≤0.5%) further contribute to the overall quality and stability of the intermediate.

When engaging with a supplier, always request a detailed Certificate of Analysis (CoA) that substantiates these specifications. Understanding the sourcing and manufacturing processes can also provide assurance. For those looking to purchase CAS 212322-56-0, partnering with a manufacturer that transparently provides this information is key. This diligence ensures that your procurement aligns with regulatory expectations and quality standards, supporting your efforts to buy this essential chemical.

In summary, focusing on appearance, high purity, controlled impurity levels, and stable physical properties are paramount when sourcing Ethyl 3-[[3-amino-4-(methylamino)benzoyl]-pyridin-2-ylamino]propanoate. Manufacturers committed to these specifications are invaluable partners for pharmaceutical companies aiming for excellence in their production pipelines. We invite you to explore our offerings as a reliable supplier committed to delivering these essential quality attributes.