In the pharmaceutical industry, the identification and control of impurities are critical for ensuring drug safety and efficacy. Riociguat Intermediate, often recognized as Riociguat Impurity 21 with CAS number 256376-65-5, plays a vital role in this process. This chemical compound, typically supplied as a yellow to dark yellow powder, serves as a crucial reference standard for analytical laboratories and pharmaceutical manufacturers.

The primary function of Riociguat Impurity 21 in pharmaceutical quality assurance is to act as a benchmark for identifying and quantifying impurities that might be present in the active pharmaceutical ingredient (API), Riociguat, or its formulated products. By having a precisely characterized standard of this impurity, analytical chemists can develop and validate methods, such as High-Performance Liquid Chromatography (HPLC) or Gas Chromatography (GC), to detect and measure its levels accurately. This rigorous analytical process is essential for meeting regulatory requirements set by bodies like the FDA and EMA, ensuring that the final drug product adheres to strict purity profiles.

The availability of Riociguat Impurity 21 as a reference standard is particularly important during the development and manufacturing phases. During process development, understanding the impurity profile helps in optimizing synthetic routes to minimize the formation of such impurities. In routine quality control, it allows for batch-to-batch consistency checks, confirming that each lot of Riociguat meets the defined specifications. Suppliers like Nanjing Xinbell Pharmaceutical Technology Co., Ltd. understand this need and provide well-characterized intermediates and impurities to support these critical functions.

The chemical characteristics of Riociguat Impurity 21, such as its melting point of 80-82°C and its specific molecular formula (C14H9FN4), are vital pieces of information for analytical chemists. This data aids in selecting appropriate analytical techniques and conditions for effective separation and detection. The supply of such detailed technical data, alongside the product itself, is a hallmark of a reliable pharmaceutical chemical supplier.

The importance of managing pharmaceutical impurities cannot be overstated. Even trace amounts of certain impurities can affect the safety, efficacy, and stability of a drug. Therefore, having access to high-quality reference standards like Riociguat Impurity 21 is not just a matter of convenience but a necessity for regulatory compliance and patient safety. The meticulous production and supply of these standards by specialized chemical companies are fundamental to the integrity of the pharmaceutical supply chain.