Elemental impurities analysis

RSSL can support the implementation of elemental impurities analysis by developing and validating methods to determine the levels of elemental impurities present in accordance with ICH Q3D guidance.


Since the ICH Q3D was published in December 2014, the USP and EP have harmonised their approach to reflect these fundamental changes to the analysis of elemental impurities.


ICH Q3D uses an elemental classification system based on toxicity studies and the use of risk-based assessments of the materials and processes used in the finished product. By following this approach, we can help you establish a suitable testing programme for your raw materials and final drug product. 

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