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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.
At RSSL, we have a dedicated and experienced metals analysis team that works with our clients to plan and deliver appropriate elemental impurities analysis. This includes a risk assessment, followed by feasibility analysis, method development and validation, and subsequent testing of the required materials for the selected elements.
Our modern, well-equipped laboratory enables us to conduct a wide range of preparation and analytical techniques, allowing for efficient elemental impurities analysis. This ensures that validations are performed successfully and in compliance with all relevant guidelines so that the final method is ready for both regulatory submission and routine testing as part of QC procedures.
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