Use of Ion Chromatography in Pharmaceutical Quality Control
The regulation of pharmaceutical ingredients and raw materials is crucial in ensuring treatment efficacy and patient safety around the globe. One of the main ways this is achieved is through the use of regional pharmacopeial testing in compliance with published methods to allow materials to be assessed against set specifications. Over recent years, the preferred methods published within these pharmacopeia has shifted to include techniques which afford increased selectivity and sensitivity over traditional wet chemistry techniques; ion chromatography is one of these techniques.
A series of examples will be explored where existing or recently added pharmacopeial methods featuring the use of ion chromatography have been used for either assay or impurity testing of raw materials, or as a starting point for the development of analytical methods for finished products. The importance of method verification and validation, respectively, will also be discussed.
Presenter: Catherine Frankis (Technical Specialist, Reading Scientific Services Ltd., United Kingdom)
Dr. Catherine Frankis (She/Her) is a technical specialist at RSSL who works across the Functional Ingredients and Investigative Analysis teams, specializing in chromatography and spectroscopy-based techniques, with a particular interest in ion chromatography. She works on projects covering a wide variety of issues, including contamination, adulteration, and the development and validation of new analytical methods within the food, pharmaceutical, and cosmetic industries.
Presenter: Stella Planou (Senior Scientist, Reading Scientific Services Ltd., United Kingdom)
Stella Planou (She/Her) is a senior scientist at RSSL who works at the Functional Ingredients team supporting in chromatography techniques mainly ion chromatography and high pressure liquid chromatography. She joined RSSL in 2022 but her background is mainly in the pharmaceutical industry following GMP guidelines which includes method development and validation, stability studies and routine analysis.
