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The Use of Ion Chromatography for Measuring Residual Ions in Drug Product

The Use of Ion Chromatography for Measuring Residual Ions in Drug Product

Ion Chromatography (IC) is a liquid chromatographic method that’s used to separate and analyze ionic molecules. IC is a preferred method to analyze active pharmaceutical ingredients (APIs), excipients, degradation products, and/or impurities that contain inorganic and organic ions, polar substances, or chemically similar analytes. IC is becoming a more prevalent analytical tool in biopharma, and is being used to develop methods to analyze pharmaceutical raw materials, intermediates, diluents, drug products and drug substances.

The Role of Ion Chromatography in Analyzing APIs

There are some clear advantages when considering IC over HPLC for API analysis, including the capability to have more automated assays as well as the ability to perform counter ion analyses of salt form drug substances, which are used to confirm both API identity and content. A number of European and United States Pharmacopeia methods rely on IC, and drug products that contain APIs which can be analyzed by Ion Chromatography per USP and Ph. Eur. monographs include:

  • Neomycin
  • Cefadroxil
  • Gentamicin
  • Bethanechol chloride

Determining Impurities & Degradation Products with Ion Chromatography

Ion Chromatography is often used in pharmaceutical analysis to identify degradation products and impurities in drug products and drug substances. Multiple ions and their concentrations can be analyzed concurrently with one IC method, providing a comprehensive understanding of degradation products and impurities with a single method, while other techniques and methods are unlikely to be able to do the same.

How Avomeen Utilizes Ion Chromatography for Pharmaceutical Testing

Avomeen’s industry-leading pharmaceutical scientists are well-versed in method development and analysis of drug products and drug substances by Ion Chromatography. If you’ve got a specific project in mind or have questions about whether IC is the right method for your project, let’s talk.

 

 

Our featured blogger is Katie Morgan, Avomeen’s Senior Director of Marketing and Business Development. She has over a decade of experience establishing and implementing client development strategies, and her broad range of experience includes strategic contract development and marketing and content development.

Learn more about Katie’s expertise and experience.