Dane O. Kildsig Chair and Head of Department of Industrial and Molecular Pharmaceutics Purdue University West Lafayette, Indiana
Nitrosamines have emerged as a significant problem for the pharmaceutical industry due to formation either during manufacturing or upon storage. For example, ranitidine has been withdrawn from the market due to NDMA formation upon storage. We have been exploring the role that crystal defects play in nitrosamine formation in the solid state, including the degradation of ranitidine. Our data shows that processing plays a significant role in increasing degradation rates. Finally, we are exploring how NMR spectroscopy can be used to quantify crystal defects and predict nitrosamine formation.
Learning Objectives:
Learn about nitrosamine formation during either drug manufacturing or upon stability
Understand the mechanisms for the formation of nitrosamines on stability
Demonstrate that crystal defects play a significant role in nitrosamine formation on stability
Understand strategies that can be used to mitigate nitrosamine formation in the solid state
