The pharmaceutical industry operates under rigorous quality control standards, where the purity of active pharmaceutical ingredients (APIs) is paramount. NINGBO INNO PHARMCHEM CO.,LTD. is dedicated to supporting these standards by providing high-quality reference materials. Among these, Ethyl 6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate, identified by its CAS number 503615-07-4, holds a significant position as an impurity reference standard for Apixaban.

Apixaban, a leading anticoagulant, is manufactured through a complex series of chemical reactions. Like any intricate synthesis, there is a possibility for the formation of by-products or related substances, which are termed impurities. The presence of these impurities, even in trace amounts, can affect the efficacy, safety, and stability of the final drug product. Therefore, accurate identification and quantification of these impurities are essential regulatory requirements.

The compound with CAS 503615-07-4 is one such related substance that can arise during the Apixaban production process. By making this compound available as a certified reference standard, NINGBO INNO PHARMCHEM CO.,LTD. enables pharmaceutical manufacturers to establish robust analytical methods, such as High-Performance Liquid Chromatography (HPLC). These methods are used to detect, identify, and quantify the presence of this specific impurity in Apixaban batches, ensuring that they comply with pharmacopoeial limits and internal specifications.

The availability of reliable reference standards is not just a matter of compliance; it is a cornerstone of patient safety. When manufacturers can accurately monitor and control impurity levels, they can guarantee that the Apixaban they produce is safe and effective for patient use. This commitment to quality extends from the raw material sourcing to the final product release.

For companies involved in Apixaban manufacturing or research, securing a dependable supply of Ethyl 6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate as a reference standard is crucial. NINGBO INNO PHARMCHEM CO.,LTD. offers this vital chemical, facilitating rigorous quality assurance and contributing to the overall integrity of the pharmaceutical supply chain. Understanding the role of such reference materials underscores the precision and dedication required in modern drug development and production.