Pulse Brain · Growing Health Evidence Index
Peer-reviewed

Near infrared spectroscopy for blend uniformity monitoring: An innovative qualitative application based on the coefficient of determination

Yves Roggo; Lizbeth Martinez; Antonio Peinado; Sanni Matero

Journal of Near Infrared Spectroscopy · 2022

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Summary

Blending process is a critical unit operation in the pharmaceutical industry during the solid dosage form production. Near infrared (NIR) spectroscopy is a powerful analytical tool to assess the blend homogeneity in real-time. In this paper, a new methodology for blending process monitoring and for end point confirmation is proposed. Quantitative procedure validation and maintenance of NIR procedures are time-consuming activities that can prevent the adoption of PAT tools in the pharmaceutical industry. Clearly, there is a need in the industry for simpler and more intuitive qualitative blend monitoring analytical procedure that are easy to build, validate and maintain. The method introduced herein consists of tracking the trend of the Coefficient of Determination (CD) between a mean refer

Source type
Peer-reviewed study
DOI
10.1177/09670335221130430
Catalogue ID
NRmo9rin9c-0ty
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