Validation of Impurity Methods, Part I

This column is the second installment in a two-part series that reviews International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and U.S. Food and Drug Administration (FDA) impurity method validation guidelines. In the first column, the authors discussed background information such as validation policy and laboratory controls that pertain to validation. In the second column, they address specifics of ICH and FDA guidelines about impurity method validation components such as specificity, linearity, and reproducibility.