ArticleThe AAPS journal2026
Hand-Held Raman Spectroscopy for Paracetamol Assay in Solution for Infusion: Expanding the Capabilities of Process Analytical Technologies.
Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Currently, the manufacture of injectable drug products relies on a quality-by-test approach, where product quality is evaluated at fixed manufacturing steps. The introduction of the quality-by-design approach, supported on process analytical technologies (PAT) is changing this paradigm. The US Food and Drug Administration established the foundations for the application of PAT in real-time control of the drug manufacturing process. One of the most versatile PAT tools is the Raman spectroscopy. Nevertheless, the application of this technique to injectables is still underexplored. This work intends to expand the use of Raman spectroscopy as a PAT tool for injectable drug products. A Raman spectroscopy method was developed for the assay of paracetamol in paracetamol infusion solutions, using a PLS (partial least squares) algorithm. The method is specific, with a root mean square error of calibration (RMSEC), cross-validation (RMSECV) and prediction (RMSEP) of 1.067%, 2.591%, and 2.601%, respectively, with R
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