Here we provide an overview of the fundamentals and best practices on the development of stability-indicating HPLC methods for drug substances and products. We explain both traditional and easier modern approaches to developing stability-indicating HPLC methods—including using a universal generic method for new chemical entities—and address regulatory considerations and life cycle management strategies.
In electromembrane extraction (EME), the target analyte is extracted from an aqueous sample across a supported liquid membrane (SLM) and analyzed using LC. Through the study presented here, we demonstrate the principles of the technique and test its performance.
Low-pressure gas chromatography (LPGC)–MS should be the first option in many GC–MS applications to provide fast, sensitive, and robust analyses; and the installation, instrumentation, and implementation of LPGC is possible in any GC–MS system.
If you are analyzing metal-sensitive biomolecules, and a bioinert instrument is unavailable, or insufficient, passivation or mobile-phase additives may help. Here’s how to use those solutions, with tips for avoiding potential pitfalls.