Characterising impurity reference standards (IRSs) remains a complex area due to the lack of detailed guidance, unlike active pharmaceutical ingredients (API) standards outlined in Ph. Eur. Chapter 5.12.1. While ICH guidelines offer flexibility in evaluating and characterising impurities, the extent of IRS characterisation should be determined by the intended analytical use—whether qualitative or quantitative.
This poster explores key methods for IRS characterisation, including system suitability testing, peak identification, and the validation of specificity parameters. It also provides guidance on using separation techniques like HPLC and GC for purity assessment and highlights the importance of accurate quantification to ensure compliance with regulatory standards.
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Characterisation of impurity standards: How good is good enough?