Practical Application of Quality by Design Principles to The Development of an HPLC Assay Method for an API and Impurities
A method for the assay of an active pharmaceutical ingredient (API) and five known and unknown impurities was developed in accordance with Quality by Design (QbD) principles.
A method for the assay of an active pharmaceutical ingredient (API) and five known and unknown impurities was developed in accordance with Quality by Design (QbD) principles. Highly influential separation parameters were simultaneously and systematically studied so that the quality of the HPLC method could be understood, controlled and ensured. Consequently, during routine analysis out of specification (OOS) results can be corrected more effectively.
Extracting Estrogenic Hormones Using Rotating Disk and Modified Clays
April 14th 2025University of Caldas and University of Chile researchers extracted estrogenic hormones from wastewater samples using rotating disk sorption extraction. After extraction, the concentrated analytes were measured using liquid chromatography coupled with photodiode array detection (HPLC-PDA).
Polysorbate Quantification and Degradation Analysis via LC and Charged Aerosol Detection
April 9th 2025Scientists from ThermoFisher Scientific published a review article in the Journal of Chromatography A that provided an overview of HPLC analysis using charged aerosol detection can help with polysorbate quantification.
Removing Double-Stranded RNA Impurities Using Chromatography
April 8th 2025Researchers from Agency for Science, Technology and Research in Singapore recently published a review article exploring how chromatography can be used to remove double-stranded RNA impurities during mRNA therapeutics production.
