Why are specificity and precision required with biorelevant media?

Specificity and precision must be performed in the presence of biorelevant media. Biorelevant dissolution media contain natural surfactants which can affect chromatographic properties leading to erroneous analytical results.
Biorelevant media typically contain components that are lipophilic which differ significantly from QC dissolution media. If undiluted biorelevant media (especially fed state) are injected into an HPLC this can adversely affect the column properties. The media can reduce the power of stationary phase (in case of reverse phase chromatography) by sticking to the silane carbon chains thereby affecting the elution power. Hence, performing specificity and precision with biorelevant media are vital for analytical method establishment.

Download our Biorelevant Dissolution Guides here.