A multidisciplinary approach is crucial in transitioning high-risk prostacyclin therapies in PAH. A successful transition from high-dose intravenous epoprostenol to high-dose subcutaneous treprostinil ...

Following high-profile recalls involving nitrosamine impurities, such as N-Nitrosodimethylamine (NDMA), regulatory bodies like the FDA and EMA now require pharmaceutical manufacturers to closely ...

These impurities are called nitrosamines and they are in food, drink and medicines, but are not allowed to be over a certain level in these products. This is because animal testing has indicated ...

Analytical chemistry in pharmaceutical analysis deals with the investigation of bulk drug materials, active pharmaceutical ingredients, intermediates, drug products, including their impurities and ...

One of the unique aspects of third-party labs is their ability to respond quickly to evolving regulatory requirements. "When new challenges arise—like the detection of nitrosamines, genotoxic ...