The Growing Regulatory Burden and Revolution in Global Clinical Trials
At the same time the pharmaceutical industry faces new and complex issues with the drug development process and clinical trial environment, regulatory policies are increasing and adding to the burden of cost and time to market.
The Benefits of DBS-GC–MS/MS in Barbiturate Detection
December 5th 2024Three analytical and two pre-treatment methods—gas chromatography–mass spectrometry (GC–MS), gas chromatography–tandem mass spectrometry (GC–MS/MS), and liquid chromatography–tandem mass spectrometry (LC–MS/MS) plus liquid-liquid extraction (LLE) and dried blood spot (DBS) —were compared for the quantitation and characterization of barbiturates.
Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter <228>.
