Particle size reduction techniques such as micronization are an essential aspect of pharmaceutical manufacturing operations – and their importance continues to grow. Micronization and other particle reduction techniques are a mainstay in addressing poor drug solubility. Once an exception rather than a rule, most new drug compounds today are highly […]

A chiral molecule is one in which the stereoisomers are mirror images of each other. These mirror images – an example of molecular symmetry – are referred to as enantiomers (see image at right – courtesy of Wikipedia). From a separation standpoint, chiral molecules pose unique challenges. Because they are […]

Impurity isolation and identification in active pharmaceutical ingredients (APIs) and pharmaceutical drug products (DPs) is a critical aspect of the development process. The need to meet the quality guidelines outlined by the ICH (International Conference on Harmonisation) and adopted by regulatory agencies worldwide would be the most obvious reason. But […]

Picking and choosing CROs and CDMOs based solely on cost can ultimately raise project costs and slow your drug development and commercialization. Several weeks ago, we were approached by a company seeking an initial preparation of 20-25 grams of an API. They were a small pharma firm, with a limited […]

Pharmaceutical solid state chemistry – the study of functional relationships between the synthesis, structure, and properties of solid phase materials – plays a crucial role in successful drug development and commercialization. As active pharmaceutical ingredients (APIs) have grown more complex, the importance of understanding the polymorphic landscapes have, as well. […]