The purity of a pharmaceutical drug product is of paramount importance to ensure drug quality from the standpoint of patient exposure to impurities. Although precautions are always implemented to optimize excipient selection, formulation process, manufacturing process and the appropriate packaging selection, impurities are still likely to be encountered. It is mainly due to degradation pathways of active pharmaceutical ingredients (API) and/or due to leachable compounds originating from the container closure system (CCS) or the manufacturing contact surfaces of the drug product. The International Conference on Harmonization (ICH) Q3B provides guidance on the control of impurities in drug products. It is important that highly selective and sensitive analytical methods are in place for the impurity investigations during the product development phase.Two case studies describing identification of impurities using a combination of GC-MS and accurate mass LC-QTOF in the pharmaceutical drug products will be presented. The mass accuracy error between the theoretical mass and the experimental mass of the identified impurities were found to be less than 0.5 ppm. An MS/MS analysis was utilized to provide mass spectrometry fragments to support verification of the identified structures.

Identification of impurities in pharmaceutical products using advanced analytical tools

Macromolecular Chemistry: The Second Century

[Author Benefits](https://scimeetings.acs.org/?utm_source=pubs_content_marketing&utm_medium=website&utm_campaign=0320_MCF_NPI_Launch_Spring_Homepage&ref=pubs_content_marketing)

[How to use SciMeetings](https://storage.googleapis.com/dl.morressier.com/acs/SciMeetings-ACSSpring2020-HowToGuide_M3020-Final.pdf)

[Frequently Asked Questions](https://storage.googleapis.com/dl.morressier.com/acs/SciMtng_ACSNMSp2020_FAQ_M3120_Final.pdf)

ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.