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.
Inside the Laboratory: The Zydney Group at Pennsylvania State University
November 26th 2024In this edition of “Inside the Laboratory,” Andrew Zydney of Pennsylvania State University discusses his laboratory’s work with using high performance liquid chromatography (HPLC) to analyze biopharmaceutical products before and after membrane separation processes.
Green Chemistry: What is it (and What Is It Not)? And How Does It Apply to Gas Chromatography?
October 31st 2024Everyone is talking about sustainability, and organizations are creating sustainability programs. But what does green chemistry really mean, and how does it apply to gas chromatography?
