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Tracking Fate and Purge of Impurities and Calculating Carryover

Vast quantities of data are collected during route scouting and process development. Much of it, to track the fate and purge of impurities. Analytical data is used to monitor the quality of the process, to assess purity of the API, and as proof to regulatory authorities of an effective control strategy.

While synthetic data is stored in electronic notebooks the associated analytical information, used to monitor impurity carry-over and calculate fate and purge, is typically transferred into Microsoft Excel spreadsheets as area % value.

Transfer of analytical data into Excel not only requires tedious manual data transcription (introducing the risk of errors), it also abstracts rich analytical information into binary form that is difficult to interrogate.

Download this application note to learn how Luminata™ software helps project teams:

  • Manage assembled synthetic routes, associated impurities, and all relevant analytical data
  • Make informed decisions based on quantitative purge factors calculated directly from LC/MS data