Development and Validation of Handheld Vibrational Spectroscopy Methods for the Quantitation of Active Ingredients in Pharmaceutical Solid Dosage Forms - 2025
Development and Validation of Handheld Vibrational Spectroscopy Methods for the Quantitation of Active Ingredients in Pharmaceutical Solid Dosage Forms
Sacre, Pierre-Yves; De Bleye, Charlotte; BECKERS, Pierreet al.
2025 • In Peru, Deborah A. (Ed.) Practical Quantitative Vibrational and Electronic Spectroscopy: A Guide for Developing, Optimizing, and Validating Procedures
Analytical Quality by Design; total analytical error; handheld Raman spectroscopy; chemometrics
Abstract :
[en] Over the last decades, vibrational spectroscopy methods such as Raman and near-infrared (NIR) spectroscopy have seen increasing adoption in the pharmaceutical industry. These techniques are valued for their non-destructive nature, rapid data acquisition, and ability to assess both physical and chemical properties of pharmaceuticals, including active ingredient levels, humidity, and polymorphism. Initially reliant on benchtop instruments for monitoring and quality control, advancements in technology have enabled the development of portable, handheld devices, facilitating a shift from the traditional “Sample to Laboratory” model to a “Laboratory to Sample” approach.
This chapter details the development and validation of a handheld Raman spectroscopy method for quantifying active ingredients in immediate-release tablets. It emphasizes the use of the Analytical Quality by Design (AQbD) framework, as defined in ICH Q14/Q2(R2) and USP <1220> guidelines, to streamline method development and adapt it to various scenarios. All important steps are exemplified and discussed to enable the user to adopt such approach and tailor it to its own application.
Research Center/Unit :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Sacre, Pierre-Yves ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
De Bleye, Charlotte ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
BECKERS, Pierre ; Centre Hospitalier Universitaire de Liège - CHU
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Ziemons, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Language :
English
Title :
Development and Validation of Handheld Vibrational Spectroscopy Methods for the Quantitation of Active Ingredients in Pharmaceutical Solid Dosage Forms
Publication date :
December 2025
Main work title :
Practical Quantitative Vibrational and Electronic Spectroscopy: A Guide for Developing, Optimizing, and Validating Procedures
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