title: Near infrared spectroscopy for qualitative comparison of pharmaceutical batches.
abstract: Pharmaceuticals are produced according to current pharmacopoeias, which require quality parameters. Tablets of identical formulation, produced by different factories should have the same properties before and after storage. In this article, we analyzed samples having two different origins before and after storage (30 degrees C, 75% relative moisture). The aim of the study is to propose two approaches to understand the differences between origins and the storage effect by near infrared spectroscopy. In the first part, the main wavelengths are identified in transmittance and reflectance near infrared spectra in order to identify the major differences between the samples. In this paper, this approach is called fingerprinting. In the second part, principal component analysis (PCA) is computed to confirm the fingerprinting interpretation. The two interpretations show the differences between batches: physical aspect and moisture content. The manufacturing process is responsible for the physical differences between batches. During the storage, changes are due to the increase of moisture content and the decrease of the active content.
authors.affiliation: Bau 65, Raum 516, Hoffmann-La Roche, Grenzacherstrasse, 4070 Basel, Switzerland. yves.roggo@roche.com
authors.forename: Y
authors.initials: Y
authors.lastname: Roggo
authors.forename: C
authors.initials: C
authors.lastname: Roeseler
authors.forename: M
authors.initials: M
authors.lastname: Ulmschneider
mesh_terms: D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry / Q000592:standards*; D019265:Spectroscopy, Near-Infrared / Q000379:methods* / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations