Quality Assurance for Ethyl 2-oxo-4-phenylbutyrate: What Buyers Should Know
In the pharmaceutical industry, the quality of raw materials and intermediates directly dictates the safety and efficacy of the final drug product. Ethyl 2-oxo-4-phenylbutyrate (CAS 64920-29-2), a critical intermediate for drugs like Lisinopril and Cilastatin, is no exception. For procurement specialists and R&D professionals, understanding the quality assurance (QA) aspects when purchasing this compound is paramount. As a dedicated manufacturer and supplier, NINGBO INNO PHARMCHEM CO.,LTD. emphasizes stringent quality controls throughout its production process.
The primary quality parameter for Ethyl 2-oxo-4-phenylbutyrate is its purity, typically specified as an assay of ≥99.0%. This high level of purity is crucial for several reasons. Firstly, it minimizes the presence of unwanted by-products or isomeric impurities that could interfere with the complex synthesis of APIs, potentially leading to reduced yields or the formation of toxic compounds. Secondly, adherence to strict purity standards ensures that the synthesized drugs meet regulatory requirements set by health authorities worldwide.
When you buy Ethyl 2-oxo-4-phenylbutyrate, it is essential to scrutinize the quality documentation provided by the supplier. Key documents include the Certificate of Analysis (CoA), which details the specific test results for each batch, including assay, moisture content, and impurity levels. Other supporting documents, such as Material Safety Data Sheets (MSDS) and technical data sheets (TDS), provide vital information on handling, storage, and chemical properties. A reputable supplier in China will readily provide these documents, demonstrating transparency and commitment to quality.
Reputable manufacturers employ rigorous analytical techniques to ensure the quality of Ethyl 2-oxo-4-phenylbutyrate. These may include High-Performance Liquid Chromatography (HPLC) for assay and impurity profiling, Gas Chromatography (GC), Nuclear Magnetic Resonance (NMR) spectroscopy for structural confirmation, and Karl Fischer titration for moisture content. Understanding the analytical methods used by your supplier can provide further confidence in the product's reliability.
For companies looking to purchase this essential intermediate, choosing a supplier that invests in robust QA systems is a critical step. It not only ensures the integrity of your product but also streamlines your own internal quality control processes. Whether you require small quantities for research or large volumes for commercial production, partnering with a supplier like us, committed to excellence in quality assurance, guarantees a product that meets the highest industry standards. This commitment to quality is a cornerstone of our service to the global pharmaceutical sector.
Perspectives & Insights
Quantum Pioneer 24
“Reputable manufacturers employ rigorous analytical techniques to ensure the quality of Ethyl 2-oxo-4-phenylbutyrate.”
Bio Explorer X
“These may include High-Performance Liquid Chromatography (HPLC) for assay and impurity profiling, Gas Chromatography (GC), Nuclear Magnetic Resonance (NMR) spectroscopy for structural confirmation, and Karl Fischer titration for moisture content.”
Nano Catalyst AI
“Understanding the analytical methods used by your supplier can provide further confidence in the product's reliability.”