AS252: Fully Automated Method For Drug Product Leachable Studies


15th August 2022

Application Note AS252 – Fully Automated Method For Drug Product Leachable Studies – describes the application of a fully automated sample preparation applied to an extractables and leachables (E+L) study. Laboratory analysts are often faced with laborious sample preparation which is time consuming and prone to errors and therefore look for ways the processes can be automated. In addition, some sample types encountered in +EL studies can be challenging both manually and for automated preparation.

With relative standard deviations (RSDs) of 13% or less, much lower than the limit of 25%, it is demonstrated that automation can meet the precision targets required. With sensitivity sometimes an issue for analysts, automated solvent exchange with the GERSTEL mVap has been shown to improve method sensitivities without reduction in performance of recovery or repeatability.

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