Technical note: The content of nevirapine and related impurities
Posted: 14 December 2021 | Thermo Fisher Scientific | No comments yet
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
In both R&D and QC pharmaceutical laboratories, determining the content of an active pharmaceutical ingredient and its related impurities are typical analyses.
While it is common to apply different methods for assay and impurity determination for one API, in practice it is preferred to combine both analyses into one single run. Automated data processing and reporting allows for a quick, reliable data evaluation and documentation, as it is required in the pharmaceutical regulated environment.
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Analytical techniques, Biologics, Biopharmaceuticals, Chromatography, Data integrity, Excipients, Formulation, Informatics, Mass Spectrometry, Proteomics, QA/QC, Regulation & Legislation, Research & Development (R&D), Spectroscopy, Vaccines
