Experimental design for the optimization and robustness testing of a liquid chromatography tandem mass spectrometry method for the trace analysis of the potentially genotoxic 1,3-diisopropylurea.
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G. Szekely | M. Gil | György Székely | Bruno Henriques | Marco Gil | Carlos Alvarez | C. Álvarez | B. Henriques
[1] Frank David,et al. Analysis of potential genotoxic impurities in pharmaceuticals by two-dimensional gas chromatography with Deans switching and independent column temperature control using a low-thermal-mass oven module , 2010, Analytical and bioanalytical chemistry.
[2] B. Sellergren,et al. Design, preparation and characterization of novel molecularly imprinted polymers for removal of potentially genotoxic 1,3-diisopropylurea from API solutions , 2012 .
[3] Coral Barbas,et al. Development of chromatographic methods for the determination of genotoxic impurities in cloperastine fendizoate. , 2012, Journal of pharmaceutical and biomedical analysis.
[4] Benjamin Debrus,et al. Application of design of experiments and design space methodology for the HPLC-UV separation optimization of aporphine alkaloids from leaves of Spirospermum penduliflorum Thouars. , 2012, Journal of pharmaceutical and biomedical analysis.
[5] E Claassen,et al. A novel carbodiimide coupling method for synthetic peptides. Enhanced anti-peptide antibody responses. , 1990, Journal of immunological methods.
[6] Zadeo Cimarosti,et al. Application of Quality by Design Principles to Support Development of a Control Strategy for the Control of Genotoxic Impurities in the Manufacturing Process of a Drug Substance , 2010 .
[7] Liping Liu,et al. Rational design of core–shell molecularly imprinted polymer based on computational simulation and Doehlert experimental optimization: application to the separation of tanshinone IIA from Salvia miltiorrhiza Bunge , 2012, Analytical and Bioanalytical Chemistry.
[8] Giancarlo Francese,et al. Confocal Raman microscopy to probe content uniformity of a lipid based powder for inhalation: a quality by design approach. , 2009, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[9] J. R. Torres-Lapasió,et al. Optimal experimental designs in RPLC at variable solvent content and pH based on prediction error surfaces , 2011, Analytical and bioanalytical chemistry.
[10] E. Rozet,et al. Innovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space. , 2011, Journal of chromatography. A.
[11] B. Sellergren,et al. Organic solvent nanofiltration: A platform for removal of genotoxins from active pharmaceutical ingr , 2011 .
[12] S. Piletsky,et al. Reichardt's dye and its reactions with the alkylating agents 4‐chloro‐1‐butanol, ethyl methanesulfonate, 1‐bromobutane and Fast Red B ‐ a potentially useful reagent for the detection of genotoxic impurities in pharmaceuticals , 2009 .
[13] Wayne A Pritts,et al. Determination of low ppm levels of dimethyl sulfate in an aqueous soluble API intermediate using liquid-liquid extraction and GC-MS. , 2009, Journal of pharmaceutical and biomedical analysis.
[14] David Q. Liu,et al. Enhancing the detection sensitivity of trace analysis of pharmaceutical genotoxic impurities by chemical derivatization and coordination ion spray-mass spectrometry. , 2010, Journal of chromatography. A.
[15] N. Sinelli,et al. Minimisation of instrumental noise in the acquisition of FT-NIR spectra of bread wheat using experimental design and signal processing techniques , 2011, Analytical and bioanalytical chemistry.
[16] B. Sellergren,et al. Removal of potentially genotoxic acetamide and arylsulfonate impurities from crude drugs by molecular imprinting. , 2012, Journal of chromatography. A.
[17] N V V S S Raman,et al. Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective. , 2011, Journal of pharmaceutical and biomedical analysis.
[18] David Q. Liu,et al. Matrix deactivation: A general approach to improve stability of unstable and reactive pharmaceutical genotoxic impurities for trace analysis. , 2010, Journal of pharmaceutical and biomedical analysis.
[19] D. Muddiman,et al. Global optimization of the infrared matrix-assisted laser desorption electrospray ionization (IR MALDESI) source for mass spectrometry using statistical design of experiments. , 2011, Rapid communications in mass spectrometry : RCM.
[20] Erik Johansson,et al. Strategy for optimizing LC-MS data processing in metabolomics: a design of experiments approach. , 2012, Analytical chemistry.
[21] Zhihong Ge,et al. Development and Validation of an HPLC Method for the Impurity and Quantitative Analysis of Etoricoxib , 2003 .
[22] David Q. Liu,et al. Recent advances in trace analysis of pharmaceutical genotoxic impurities. , 2010, Journal of pharmaceutical and biomedical analysis.
[23] B. Sellergren,et al. Environmental and economic analysis for selection and engineering sustainable API degenotoxification processes , 2013 .
[24] Cyrus Agarabi,et al. Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate. , 2012, Journal of pharmaceutical and biomedical analysis.
[25] Frederick G Vogt,et al. Development of quality-by-design analytical methods. , 2011, Journal of pharmaceutical sciences.
[26] G. J. Jong,et al. A new approach for generic screening and quantitation of potential genotoxic alkylation compounds by pre-column derivatization and LC-MS/MS analysis , 2011, Analytical and bioanalytical chemistry.
[27] B. Sellergren,et al. A hybrid approach to reach stringent low genotoxic impurity contents in active pharmaceutical ingredients: Combining molecularly imprinted polymers and organic solvent nanofiltration for removal of 1,3-diisopropylurea , 2012 .
[28] C. Welch,et al. Removal of Electrophilic Potential Genotoxic Impurities Using Nucleophilic Reactive Resins , 2010 .
[29] Lutz Müller,et al. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. , 2006, Regulatory toxicology and pharmacology : RTP.
[30] M. Careri,et al. Optimization of headspace sampling using solid‐phase microextraction for chloroanisoles in cork stoppers and gas chromatography–ion‐trap tandem mass spectrometric analysis , 2003 .
[31] G. Szekely,et al. Design of experiments as a tool for LC-MS/MS method development for the trace analysis of the potentially genotoxic 4-dimethylaminopyridine impurity in glucocorticoids. , 2012, Journal of pharmaceutical and biomedical analysis.
[32] K. Mukkanti,et al. Development and validation of RP-UPLC method for the determination of darifenacin hydrobromide, its related compounds and its degradation products using design of experiments. , 2012, Journal of pharmaceutical and biomedical analysis.
[33] E. J. Song,et al. Experimental design optimization of the capillary electrophoresis separation of leucine enkephalin and its immune complex. , 2007, Journal of separation science.
[34] David Q. Liu,et al. A Systematic Method Development Strategy for Determination of Pharmaceutical Genotoxic Impurities , 2010 .
[35] H. Gally,et al. Overall impact of the regulatory requirements for genotoxic impurities on the drug development process. , 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[36] Benjamin Debrus,et al. Application of new methodologies based on design of experiments, independent component analysis and design space for robust optimization in liquid chromatography. , 2011, Analytica chimica acta.
[37] J. Fekete,et al. Rapid high performance liquid chromatography method development with high prediction accuracy, using 5cm long narrow bore columns packed with sub-2microm particles and Design Space computer modeling. , 2009, Journal of chromatography. A.