Validation of ion chromatographic (IC) methods according to USP <1225>

Pharmaceutical manufacturers must meet rigorous regulatory requirements to ensure the safety, efficacy, and consistency of their products. To analyze the active ingredients, impurities, and degradation products in pharmaceuticals, ion chromatography (IC) offers a robust alternative to traditional techniques like high performance liquid chromatography (HPLC). Growing expectations from the Food and Drug Administration (FDA) and other authorities have made ion chromatography method validation a critical component in pharmaceutical labs and developments.

This White Paper demonstrates the determination of performance characteristics required by United States Pharmacopeia (USP) General Chapters, such as accuracy, precision, and specificity, using the lithium assay in lithium citrate as a practical case study. It addresses how system suitability tests and the assessment of analyte concentration across expected ranges ensure that IC methods are fit for purpose. Additionally, it demonstrates how validated IC methods could be used to control active ingredients, verify the quality of raw materials, and detect degradation compounds in finished pharmaceuticals.
 

Key learning points:  

• How to apply USP <1225> criteria for IC method validation in the analysis of finished pharmaceutical products
• Practical guidance on performing method validation and its analytical characteristics – including quantitative assays and system suitability tests
• The importance of evaluating accuracy, precision, specificity, linearity, and other data elements required for a fully validated analytical method
• Real-world example of lithium citrate assay showcasing how IC meets the requirements for a product quality assessment according to USP