The measurement of very low levels of elemental impurities is a regulatory requirement, described in ICH Q3D and USP232 – 233. Contaminants in APIs (Active Pharmaceutical Ingredients) may be derived from catalysts or from reagents and starting materials. Contaminants in excipients may also be present due to their natural origin. Strict limits apply, and Brightlabs is able to apply state-of-the-art techniques to develop and validate quantitative test methods.
In API manufacture it is desirable to understand the elemental impurity levels in starting materials as part of a risk-mitigation strategy for validation. Brightlabs is able to help with the development of a suitable limit test.