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.
LCGC North America
Click the title above to open the LCGC North America August 2020 issue, Volume 38, Number 8, in an interactive PDF format.
When forced to teach separation science with little or no access to a laboratory, chromatography simulators can help. Here, we describe several that are both useful and free.
A U.S. government-sponsored report released last year puts a spotlight on critical concerns affecting the future of separation science.
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.
LCGC North America
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.
