Module 3 Presentations

07/05/2024

Tests employed in the routine use a method that assures that the method is performing, or will perform, as expected and within its validated parameters HPLC example ● Reproducibility – 6 injections of a standard, RSD < 1% ● Resolution between closest eluting components ● Tailing factor System Suitability

The Organisation for Professionals in Regulatory Affairs

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Drug Substance Impurities Organic Impurities by HPLC

• Validation suite very similar to main band assay • Limit of detection, limit of quantitation need consideration • The range of the linearity experiment needs careful consideration. • How do main band and impurities linearities interact (method design)? • RRFs for individual impurities?

The Organisation for Professionals in Regulatory Affairs

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