The pharmaceutical industry places an unwavering emphasis on product quality and safety. For complex APIs like butoconazole, a well-known antifungal agent, maintaining stringent quality control throughout the manufacturing process is critical. In this context, understanding and managing process-related impurities is paramount. 1-(2-Chloro-4-(4-chlorophenyl)butyl)-1H-imidazole (CAS: 67085-12-5) plays a significant dual role: it's a key intermediate in the synthesis of butoconazole, and it also functions as a critical impurity reference standard.

From Intermediate to Impurity Standard

As a chemical intermediate, 1-(2-Chloro-4-(4-chlorophenyl)butyl)-1H-imidazole, with its molecular formula C13H14Cl2N2 and appearance as a white powder, is essential for building the final butoconazole molecule. Its high purity, often u226598.0%, directly influences the quality of the final API. However, due to its presence in the synthetic pathway, it can also appear as an impurity in the finished butoconazole product. This makes it an invaluable tool for analytical chemists and quality control professionals.

Manufacturers utilize precisely characterized batches of 1-(2-Chloro-4-(4-chlorophenyl)butyl)-1H-imidazole as reference standards. These standards are used to develop and validate analytical methods, such as High-Performance Liquid Chromatography (HPLC), to accurately detect and quantify its presence in butoconazole batches. By establishing a baseline for this impurity, pharmaceutical companies can ensure that their products meet the strict regulatory limits set by health authorities worldwide. This process is vital for guaranteeing the safety and efficacy of the antifungal medication.

Ensuring API Purity: Procurement and Analysis

For procurement managers, sourcing high-quality 1-(2-Chloro-4-(4-chlorophenyl)butyl)-1H-imidazole for both synthetic purposes and as a reference standard requires diligence. Partnering with a reputable manufacturer and supplier, particularly one based in China with a strong track record in producing pharmaceutical intermediates, is crucial. When purchasing, it's important to request detailed specifications, including purity assays, and Certificates of Analysis (CoAs) that confirm the lot’s identity and purity.

The analytical characterization of this compound often involves techniques like Nuclear Magnetic Resonance (NMR) spectroscopy, Mass Spectrometry (MS), and FT-IR spectroscopy, in addition to HPLC. These methods confirm the chemical structure and purity, which are essential for its role as a reference standard. The availability of comprehensive analytical data from the supplier is a strong indicator of their commitment to quality.

Strategic Sourcing for Quality Assurance

When you need to buy 1-(2-Chloro-4-(4-chlorophenyl)butyl)-1H-imidazole, consider its critical role in quality assurance. A reliable supplier will not only offer competitive pricing but also consistent quality and documentation to support your quality control procedures. Engaging with manufacturers who understand the nuances of pharmaceutical intermediates and impurity standards will ensure that your procurement decisions contribute to the overall safety and efficacy of your antifungal products.

For companies looking to buy this essential compound, focusing on suppliers who provide high-purity material for both synthesis and quality control applications is a strategic advantage. Investigate manufacturers and suppliers that can offer the necessary certifications and consistent quality, thereby supporting your commitment to pharmaceutical excellence.