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The process of impurity analysis is tightly regulated by institutions such as ICH and FDA, and is a key quality control step in pharmaceutical and biopharmaceutical production. In synthetic organic chemistry, the chances of obtaining a single final product of 100% are minimal and always produce by-products, for example, in the case of Paracetamol bulk, diacetylated paracetamol (Fig. 1) may form as a bi product.1 Organic impurities may occur during pharmaceutical manufacturing and storage. They may be known or unidentified and may be volatile or non-volatile. Their sources include raw materials, intermediates, by-products, degradation products, catalysts, and the like. In all cases, these organic impurities lead to undesired biological activity, affecting product quality and even causing toxic risks to patients, such as genotoxic drug impurities of recent interest.
Fig. 1 Production of Paracetamol from intermediate p-aminophenol
Alfa Chemistry's experienced experts are always on the lookout for the latest USP, ICH and other regulations to help our global customers provide the most suitable testing services. Equipped with state-of-the-art equipment and powerful data analysis capabilities, Alfa Chemistry is the ideal partner for the analysis of organic impurities in the pharmaceutical industry, providing comprehensive expertise to help your products meet and exceed regulatory standards, bringing quality and safety to every personal life.
Alfa Chemistry's technologies for organic impurities analysis include but not limited to: