Elemental analysis equipment corresponding to the guidelines for elemental impurities in pharmaceuticals.

Analytical instruments for evaluating impurity elements, ICP-MS and ICP-OES.

This application note introduces the analytical devices necessary to comply with the elemental impurity guidelines for pharmaceuticals issued by the Ministry of Health, Labour and Welfare on September 30, 2015. The Q3D metal elemental impurities are stated to apply to new pharmaceuticals for which approval applications are submitted on or after April 1, 2017, according to this guideline. ICH Q3D establishes a risk-based assessment method to identify and evaluate elemental impurities in formulations and to set management methods. This assessment is required not only for potential elemental impurities in the formulation itself but also for potential elemental impurities that may be introduced from each component of the formulation (active pharmaceutical ingredients, excipients, container closure systems).

Analytical Equipment and Devices