Closing a gap in the current literature by addressing the evaluation and quality assessment of raw data, this practice-oriented guide is clearly divided into three parts. The first describes basic considerations of chromatographic data quality, common errors and potential pitfalls in reading out and quantifying the data. Part two systematically covers the most important chromatographic methods as well as the specific requirements for obtaining good chromatographic data. The final part looks at data quality from the perspective of those regulatory authorities demanding certain standards in data quality, describing in detail best practices. Written with the practitioner in mind, the text not only teaches the mathematical basics but also provides invaluable advice.
Hans-Joachim Kuss is the head of biomedical analytics at the psychiatric hospital of the Ludwig Maximilian University in Munich. He has specialised on HPLC analysis of pharmaceuticals and regularly teaches courses for students and technicians on this topic. Stavros Kromidas works as an independent consultant for analytical chemistry. For more than 20 years he has regularly held lectures and training courses on HPLC, and has authored numerous articles and several best-selling books on various aspects of chromatography.
EVALUATION AND ESTIMATION OF CHROMATOGRAPHIC DATA Evaluating Chromatograms (Hans-Joachim Kuss and Daniel Stauffer) Integration Parameters (Daniel Stauffer and Hans-Joachim Kuss) Integration Errors (Hans-Joachim Kuss) Simulation of Chromatograms (Uwe Neue) Integration of Asymmetric Peaks (Hans-Joachim Kuss) Deconvolution (Mike Hillebrand) General Interpretation of Analytical Data (Joachim Ermer) Metrological Aspects of Chromatographic Data Evaluation (Ulrich Panne) CHARACTERIZATION OF THE EVALUATION OF DIFFERENT CHROMATOGRAPHIC MODES Evaluation and Estimation of Chromatographic Data in GC (Werner Engewald) Data evaluation in LC-MS (Hartmut Kirchherr) Evaluation of Chromatography Data in Ion Chromatography (Heiko Herrmann and Detlef Jensen) Qualification of GPC/GFC/SEC Data and Results (Daniela Held and Peter Kilz) REQUIREMENTS FOR CHROMATOGRAPHIC DATA ANALYSIS FROM THE VIEWPOINT OF ORGANISATIONS AND PUBLIC AUTHORITIES The Science Behind the Pharmaceutical Regulatory Chromatographic Procedures (Linda Ng) Interpretation of Chromatographic Data According to the Pharmacopoeias-Control of Impurities (Ulrich Rose) Requirements of (Chromatographic) Data in Pharmaceutical Analysis (Joachim Ermer) Evaluation and Valuation of Chromatographic Data (Stavros Kromidas)