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Updated: Jul 26, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
Development and validation of a method for the polymorphic analysis of pharmaceutical preparations using near
1Departament de Química, Unitat de Química Analítica, Facultat de Ciències, Universitat Autònoma de Barcelona, E-08193 Bellaterra, Spain. marcel.blanco@uab.es
Abstract:
A new method for the characterization and determination of crystalline miokamycin in a pharmaceutical preparation using near infrared spectroscopy is proposed. The procedure involves the identification against a spectral library of samples with contents above the legal limit (viz. 5% of the crystalline form in amorphous miokamycin) using the Mahalanobis distance as the discriminating criterion, and the determination of the total and crystalline contents using partial least squares models that provide errors <1%. The proposed method was validated following the ICH guidelines. Its simplicity and expeditiousness make it highly suitable for quality control analyses of solid dosage forms.
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