Validation and Implementation of In-Process Control HPLC Assays for Active Pharmaceutical Ingredients

Researchers investigating the relationship between cannabis use during pregnancy and depressive symptoms—and whether continued use beyond the first trimester or higher levels of use were linked to increased symptoms—used liquid chromatography–tandem mass spectrometry (LC–MS/MS) to confirm the presence of 11-nor-9-carboxy-delta-9-tetrahydrocannabinol (THC-COOH) in urine samples.

Analytical scientists are faced with the task of finding the right column from an almost unmanageable range of products. This paper focuses on columns that enable protein analysis under native conditions through size exclusion, hydrophobic interaction, and ion exchange chromatography. It will highlight the different column characteristics—pore size, particle size, base matrices, column dimensions, ligands—and which questions will help decide which columns to use.

Karolinska University Hospital researchers recently tested new approaches for analyzing drugs of abuse in oral fluids.

A recent roundtable discussion featuring Aloka Srinivasan of Raaha, Mayank Bhanti of the United States Pharmacopeia (USP), and Amber Burch of Purisys discussed the challenges surrounding nitrosamine analysis in pharmaceuticals.