Reference : Quantitative analysis using near infrared spectroscopy, Application to tablet content un...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/12815
Quantitative analysis using near infrared spectroscopy, Application to tablet content uniformity, I. Methodology
English
[fr] Le dosage par spectroscopie proche infrarouge, Application au test de l'uniformité de teneur des comprimés, I. Méthodologie
Ginot, Y. M. [Technologie Servier > > > >]
Bernard-Moulin, P. [Thermo Fisher Scientific > > > >]
Cinier, R. [Bruker Optics > > > >]
Despagne, F. [ABB > > > >]
Dubost, J. P. [Université Bordeaux 2 Victor Segalen > Pharmacie > Laboratoire de Chimie Analytique > >]
Francès, L. [Beaufour Ipsen Industrie > > > >]
Le Bihan, M. [Buchi > > > >]
Le Page, M. [Sanofi-Aventis > > > >]
Michelet, A. [Perkin Elmer > > > >]
Meunieur, L. [Technologie Servier > > > >]
Monteillet, G. [Merial > > > >]
Quintana, A. [Sanofi-Aventis > > > >]
Rieutord, A. [Hôpital Antoine-Béclère > > > >]
Storme, I. [AGEPS > > > >]
Thenevot, F. [Beaufour Ipsen Industrie > > > >]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Apr-2010
STP PHARMA PRATIQUES
Editions de Santé
20
2
117-135
No
International
1157-1497
Paris
Fance
[en] Near infrared spectroscopy ; Content uniformity ; Modeling ; Chemometrics ; Validation
[en] This first document describes guidelines to develop a quantification method for active pharmaceutical ingredient content in solid dose formulation, using near-infrared spectroscopy. This new approach offers several advantages over classical techniques, in particular for tablets content uniformity determination. This document is intended to help users addressing the numerous questions pertaining to number and types of samples, usable spectral range for quantification, importance of the reference method, development of a model and potential pitfalls, use of chemometrics tools and method validation. It also offers a statistical support that used as an aid for decision for routine controls, when a sample falls near acceptance limits. The document gathers basic principles and will be complemented by a second article with practical examples to illustrate the methodology.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/12815

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