Mass Spectrometry

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Dried tangerine peel isolated on white background | Image Credit: © leungchopan - stock.adobe.com

Researchers from Nanjing University of Chinese Medicine leveraged ultrahigh-pressure liquid chromatography coupled to quadrupole time-of-flight mass spectrometry (UHPLC–QTOF-MS) and network pharmacology to identify potential quality markers of three processed Qingpi products and elucidate their mechanism in liver disease treatment.

Photo Credit: Oligo Factory

LCGC and Spectroscopy Editor Patrick Lavery spoke with Oligo Factory CEO Chris Boggess about the company’s recently attained compliance with Good Manufacturing Practice (GMP) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Group (Q7) guidance and its distinction from Research Use Only (RUO) and International Organization for Standardization (ISO) 13485 designations.

Performing chromatographic peak purity assessments (PPA) in the pharmaceutical industry | Image Credit: © Vladimir Polikarpov - stock.adobe.com

This review article discusses scientific rationales and current best practices in the pharmaceutical industry for performing chromatographic peak purity assessments (PPA). These activities are associated with the development and validation of liquid chromatographic (LC) stability-indicating analytical methods applicable to regulatory submissions of small-molecule drug candidates. The discussion includes a comprehensive overview of the PPA-related regulatory and scientific landscape and common industry approaches to obtain PPA results, as well as the strengths and weaknesses of PDA-facilitated ultraviolet (UV) PPA and other PPA techniques.