LEADER 05320nam 2200649Ia 450 001 9910830641003321 005 20230721030648.0 010 $a1-281-32024-2 010 $a9786611320249 010 $a0-470-98874-6 010 $a0-470-99422-3 035 $a(CKB)1000000000401063 035 $a(EBL)350928 035 $a(OCoLC)476169700 035 $a(SSID)ssj0000102932 035 $a(PQKBManifestationID)11108581 035 $a(PQKBTitleCode)TC0000102932 035 $a(PQKBWorkID)10061034 035 $a(PQKB)10096807 035 $a(MiAaPQ)EBC350928 035 $a(EXLCZ)991000000000401063 100 $a20060519d2007 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aAnalysis of drug impurities$b[electronic resource] /$fedited by Richard J. Smith and Michael L. Webb 210 $aOxford ;$aAmes, Iowa $cBlackwell$d2007 215 $a1 online resource (290 p.) 225 1 $aAnalytical chemistry series 300 $aDescription based upon print version of record. 311 $a1-4051-3358-9 320 $aIncludes bibliographical references and index. 327 $aAnalysis of Drug Impurities; Contents; Preface; List of contributors; 1 Organic impurities in drug substance: origin, control, and measurement; 1.1 Introduction; 1.2 Origin of impurities; 1.2.1 Process impurities; 1.2.2 Degradation impurities; 1.2.3 Contamination impurities; 1.2.4 Other impurities; 1.3 Control of drug substance impurities; 1.3.1 Control of residual solvents; 1.3.2 Control of synthetic impurities; 1.3.3 Control of impurities in biological and botanical products; 1.3.4 Purification processes; 1.3.5 Control of impurities from packaging; 1.3.6 Control of contamination impurities 327 $a1.3.7 Control of degradants on stability1.4 Measurement of drug substance impurities; 1.4.1 HPLC; 1.4.2 GC; 1.4.3 CE; 1.4.4 General considerations; 1.5 Conclusions; Disclaimer; References; 2 Organic impurities in drug products: origin, control and measurement; 2.1 Introduction; 2.2 Analytical methodology; 2.3 Drug-excipient compatibility experimental design; 2.4 Degradation mechanisms; 2.5 Excipients' role in drug product destabilisation; 2.6 Processing as a source of moisture; 2.7 Hydrolysis; 2.8 Oxidation; 2.9 Photolysis; 2.10 Impact of processing on photostability 327 $a2.11 Miscellaneous reactions2.12 Container-closure systems; References; 3 Stereochemical impurities; 3.1 Introduction; 3.2 Separation techniques: direct resolution; 3.2.1 HPLC using CSPs; 3.2.2 HPLC using chiral mobile-phase additives; 3.2.3 Capillary electrophoresis using chiral selectors; 3.2.4 Supercritical fluid chromatography using chiral stationary phases; 3.2.5 Gas chromatography using chiral stationary phases; 3.3 Separation techniques: indirect resolution; 3.4 Non-separation techniques; 3.4.1 Chiroptical spectroscopy; 3.4.2 Nuclear magnetic resonance spectroscopy; 3.5 Conclusions 327 $aAcknowledgementsReferences; 4 Low-level measurement of potent toxins; 4.1 Introduction; 4.2 Classes of genotoxic impurity; 4.2.1 Alkylating agents; 4.2.2 Reactive amines; 4.2.3 Fused tricyclics; 4.2.4 Substituted purines and pyrimidines; 4.2.5 Hydroperoxides; 4.3 The analytical challenge of genetic; 4.4 Gas chromatography; 4.4.1 Sample introduction techniques; 4.4.2 Detectors; 4.5 High-performance liquid chromatography; 4.5.1 Separation modes; 4.5.2 Detection techniques; 4.6 Supercritical fluid chromatography; 4.7 Thin-layer chromatography; 4.8 Sample pre-concentration 327 $a4.8.1 Liquid-liquid extraction4.8.2 Solid-phase extraction; 4.8.3 Solid-phase microextraction; 4.8.4 Liquid-phase microextraction; 4.9 Other techniques; 4.9.1 Electrochemical measurements; 4.9.2 Derivatisation methods; 4.10 Adapting analytical methods from fields beyond pharmaceuticalsimpurities analysis; 4.10.1 Antineoplastic agents; 4.10.2 Other fields; 4.11 Validation of trace analytical methods; 4.11.1 Sensitivity; 4.11.2 Specificity; 4.11.3 Accuracy; 4.11.4 Solution stability; 4.11.5 Linearity and precision; 4.12 Conclusions; References; 5 A systematic approach to impurity identification 327 $a5.1 Introduction 330 $aA key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods.Written for both practic 410 0$aAnalytical chemistry series. 606 $aDrugs$xAnalysis 606 $aMateria medica 615 0$aDrugs$xAnalysis. 615 0$aMateria medica. 676 $a615.1901 676 $a615/.1901 701 $aSmith$b Richard J$0118377 701 $aWebb$b Michael L$092608 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830641003321 996 $aAnalysis of drug impurities$92202139 997 $aUNINA