In the highly regulated pharmaceutical industry, the quality and safety of Active Pharmaceutical Ingredients (APIs) are of utmost importance. A critical aspect of API quality assurance is the meticulous control of impurities. Even trace amounts of certain impurities can significantly impact the efficacy, safety profile, and stability of a drug product. For antifungal medications, such as Butoconazole, understanding and controlling its potential impurities is a non-negotiable part of the manufacturing and quality control process. This article highlights the role of specific chemical intermediates in this vital area, focusing on compounds like 1-[4-(4-Chlorophenyl)-2-hydroxylbutyl]imidazole (CAS: 67085-11-4).

The Challenge of Impurity Profiling in Pharmaceuticals

During the synthesis of APIs, various side reactions, degradation pathways, or residual starting materials can lead to the formation of impurities. Identifying, quantifying, and setting acceptable limits for these impurities is a complex but essential task. Regulatory bodies worldwide mandate strict controls on API impurities. This often necessitates the use of highly pure reference standards for analytical testing, method validation, and ongoing quality monitoring. For procurement managers and quality control scientists, sourcing these precise reference standards from reliable manufacturers is key.

1-[4-(4-Chlorophenyl)-2-hydroxylbutyl]imidazole as a Butoconazole Impurity Standard

The chemical compound 1-[4-(4-Chlorophenyl)-2-hydroxylbutyl]imidazole, with CAS number 67085-11-4, has been identified as a known impurity in the synthesis or degradation of Butoconazole, an important antifungal agent. As a result, it serves as a valuable analytical standard for pharmaceutical manufacturers. By having access to a high-purity sample of this specific compound, quality control laboratories can accurately detect and quantify its presence in Butoconazole batches. This ensures that the final drug product adheres to all regulatory specifications and safety standards. If your organization requires this specific impurity standard for your quality assurance protocols, partnering with a reliable chemical supplier is essential.

Why Partner with a Dedicated Manufacturer?

NINGBO INNO PHARMCHEM CO.,LTD., as a leading manufacturer and supplier of pharmaceutical intermediates in China, understands the critical need for accurately characterized and high-purity impurity standards. We provide 1-[4-(4-Chlorophenyl)-2-hydroxylbutyl]imidazole with guaranteed purity, ensuring it serves effectively as a reference standard for Butoconazole quality control. Our commitment to quality and consistent supply means you can rely on us for your procurement needs, whether for R&D or commercial production. We encourage you to contact us to inquire about purchasing this crucial compound and to learn more about our comprehensive range of pharmaceutical intermediates.

Ensuring the quality of APIs like Butoconazole relies heavily on the availability and integrity of impurity standards. By sourcing these critical compounds from reputable manufacturers, the pharmaceutical industry can uphold its commitment to patient safety and drug efficacy.