June 2024

In the pharmaceutical industry, the development and manufacture of Active Pharmaceutical Ingredients (APIs) require meticulous attention to quality control and impurity management. One particularly challenging class of impurities to address is the N-nitrosamines, also known as N-nitroso compounds. These impurities have garnered significant attention in recent years due to their potential carcinogenic properties, leading to

The development of Active Pharmaceutical Ingredients (APIs) is a complex and meticulous process that requires stringent quality control measures to ensure the safety and efficacy of the final drug product. One critical aspect of this process is the identification and quantification of impurities, which can have significant implications for the overall quality and safety of

Pharmaceutical products require stringent purity standards to guarantee their safety and effectiveness. Despite these efforts, impurities can still arise during production. These impurities can originate from various sources, including starting materials, by-products, synthesis intermediates, and degradation products. Identifying and controlling these impurities is crucial for ensuring the quality and efficacy of the final product. With