USP <1660> Analytical Strategies: Pharmaceutical Glass Delamination Studies

Glass remains the preferred option for parenteral or injectable drugs, yet its interaction with drug products necessitates thorough evaluation due to potential issues such as leaching, ion exchange, and delamination.

In this guide, in accordance with USP <1660>, we discuss various test methods typically applied to evaluate the interaction of the DP (drug product) or a simulant solution with the glass container after normal or accelerated storage conditions at different time points. We will also cover DIC Microscopy and SEM investigation of the inner vial glass surface (SEM, DIC); Monitoring of elemental composition by ICP; Particle screening (PS), and more! 

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