In the highly regulated world of pharmaceutical manufacturing, the quality of raw materials and intermediates is non-negotiable. Ethyl 2-oxo-4-phenylbutyrate (CAS 64920-29-2), a key intermediate, must meet stringent specifications to ensure the efficacy, safety, and consistency of the final drug products. These specifications cover its physical appearance, chemical purity, and the absence of critical impurities, all of which are vital for its performance in complex synthetic pathways.

The primary specification for Ethyl 2-oxo-4-phenylbutyrate is its assay purity, which typically needs to be 95.0% or higher, often reaching 98.0% or 99.0% for demanding applications. This high purity level ensures that the compound is primarily the desired molecule, minimizing the presence of other chemical species that could interfere with downstream reactions or introduce unwanted byproducts into the final drug. For instance, when used in the synthesis of Lisinopril or Cilastatin, even small amounts of impurities could lead to altered reaction kinetics or the formation of toxic or ineffective compounds.

Beyond assay purity, other critical specifications often include water content, usually specified as ≤0.5% or even lower. Excessive moisture can lead to hydrolysis of the ester or keto group, degrading the intermediate and impacting reaction yields. Additionally, limits are placed on specific known impurities, such as phenyl ethyl alcohol or diethyl oxalate, which might arise from the synthesis process itself. The precise control and monitoring of these impurities are essential for regulatory compliance and product quality. The appearance, described as a light yellow oily liquid, also serves as an initial indicator of quality and consistency.

Manufacturers like NINGBO INNO PHARMCHEM CO.,LTD. adhere to rigorous quality control protocols to ensure their Ethyl 2-oxo-4-phenylbutyrate meets these exacting standards. This includes utilizing advanced analytical techniques such as Gas Chromatography (GC) for purity assessment, Karl Fischer titration for water content, and High-Performance Liquid Chromatography (HPLC) for impurity profiling. Compliance with international pharmacopoeial standards (USP, BP, EP) further validates the quality of the intermediate.

For pharmaceutical companies, consistently sourcing Ethyl 2-oxo-4-phenylbutyrate that meets all specified parameters is crucial. It not only guarantees the integrity of their manufacturing process but also underpins the quality and reliability of the medicines they produce. Therefore, a strong partnership with reputable suppliers who prioritize and meticulously control these specifications is fundamental to success in the pharmaceutical industry.