caa a22 4500 463191552 CHVBK 20180406164910.0 cr unu---uuuuu 170326e20070901xx s 000 0 eng 10.1007/s10973-006-7962-y doi (NATIONALLICENCE)springer-10.1007/s10973-006-7962-y Comparison of quantitative methods for analysis of polyphasic pharmaceuticals [Elektronische Daten] [Danielle Giron, S. Monnier, M. Mutz, P. Piechon, T. Buser, F. Stowasser, K. Schulze, M. Bellus] Adequate very sensitive quantification methods are needed for the development and are also now required for the monitoring of undesirable solid form(s) as routine tests. The pre-requisite for quantitation are selectivity, sensitivity and most important the purity of standards and their proper storage, what is a challenge for metastable forms. Several analytical techniques are available such as X-ray diffraction, spectroscopy, thermal analysis and microcalorimetry. The different steps of the validation of the analytical methods and problems to be solved are discussed. Examples illustrate the different techniques and compare their possible advantages and limits. The relative standard deviation of measurements should allow for checking the homogenization procedure of mixtures for calibration. The validation should be carried out following ICH guidelines for validation of analytical methods. Comparison of different techniques in adequate concentration range add confidence in the analytical results. Springer Science+Business Media LLC, 2007 amorphous content of drug substances nationallicence crystalline nationallicence drug products nationallicence FTIR nationallicence FT-Raman nationallicence microcalorimetry nationallicence phase changes nationallicence polymorphism nationallicence pseudopolymorphism nationallicence quantitative analysis nationallicence solution calorimetry nationallicence thermal analysis nationallicence X-ray diffraction nationallicence Giron Danielle Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut Monnier S. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut Mutz M. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut Piechon P. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut Buser T. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut Stowasser F. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut Schulze K. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut Bellus M. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut Journal of Thermal Analysis and Calorimetry Springer US; http://www.springer-ny.com 89/3(2007-09-01), 729-743 1388-6150 89:3<729 2007 89 10973 https://doi.org/10.1007/s10973-006-7962-y text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10973-006-7962-y text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Giron Danielle Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut NATIONALLICENCE 700 1- Monnier S. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut NATIONALLICENCE 700 1- Mutz M. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut NATIONALLICENCE 700 1- Piechon P. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut NATIONALLICENCE 700 1- Buser T. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut NATIONALLICENCE 700 1- Stowasser F. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut NATIONALLICENCE 700 1- Schulze K. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut NATIONALLICENCE 700 1- Bellus M. Novartis Pharma, Chemical and Analytical Research and Development, Basel, Switzerland aut NATIONALLICENCE 773 0- Journal of Thermal Analysis and Calorimetry Springer US; http://www.springer-ny.com 89/3(2007-09-01), 729-743 1388-6150 89:3<729 2007 89 10973 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer