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Kalibrationsmodelle zur Bestimmung des Wassergehaltes pharmazeutischer Hilfsstoffe mittels Nah-Infrarot-Spektroskopie (NIRS)

Jutta Beyer^a*) und Klaus-Jürgen Steffens^b

Zentralinstitut Arzneimittelforschung GmbH^a, Sinzig, und Pharmazeutisches Institut, Pharmazeutische Technologie, Rheinische Friedrich-Wilhelms-Universität^b, Bonn

Calibration models for determination of water content in pharmaceutical excipients using near-infrared spectroscopy (NIRS)

Determination of water content in pharmaceutical excipients is a major pre-requisite in prediction of compounds process characteristics. For determination of water content different methods are well established according to the pharmacopoeias. However all these methods are labour intensive, destructive and time con-suming due to extended sample preparation. Alternatively NIR calibration models could be developed to facilitate and speed up standard pharmaceutical quality control. The excipient classes lactoses, starches, magnesium stearates and microcrystalline celluloses were investigated. In spite of some remarkable deviations in the physicochemical characteristics of the samples in one class, precise analytics could be achieved with only one calibration model. Consequently, near-infrared spectroscopy (NIRS) can be used as a fast, non destructive method for the determination of water content without sample preparation.

Key words Nah-Infrarot-Spektroskopie (NIRS), · Pharmazeutische Hilfsstoffe, · Qualitätssicherung, Wassergehalt