Near-infrared spectroscopy; Method Validation; Results Accuracy; Process Analytical Technology; Review
Abstract :
[en] Based on the large number of publications reported over the past five years, near-infrared spectroscopy (NIRS) is more and more considered an attractive and promising analytical tool regarding Process Analytical Technology and Green Chemistry. From the reviewed literature, few of these publications present a thoroughly validated NIRS method even if some guidelines have been published by different groups and regulatory authorities. However, as any analytical method, the validation of NIRS method is a mandatory step at the end of the development in order to give enough guarantees that each of the future results during routine use will be close enough to the true value. Besides the introduction of PAT concepts in the revised document of the European Pharmacopoeia (2.2.40) dealing with near-infrared spectroscopy recently published in Pharmeuropa, it agrees very well with this mandatory step. Indeed, the latter suggests to use similar analytical performance characteristics than those required for any analytical procedure based on acceptance criteria consistent with the intended use of the method.
In this context, this review gives a comprehensive and critical overview of the methodologies applied to assess the validity of quantitative NIRS methods used in pharmaceutical applications.
Research center :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
De Bleye, Charlotte ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Chavez, Pierre-François ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Mantanus, Jérôme ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Language :
English
Title :
Critical Review of Near-Infrared Spectroscopic Methods Validations in Pharmaceutical Applications
Publication date :
2012
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Elsevier Science, Oxford, United Kingdom
Volume :
69
Pages :
125-132
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie [BE] F.R.S.-FNRS - Fonds de la Recherche Scientifique [BE]
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