Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
7688941 | TrAC Trends in Analytical Chemistry | 2016 | 55 Pages |
Abstract
Residual solvents play an important role in the synthesis of drugs and in product formulations. In addition, they pose a serious problem, that is toxicity, as many of them exhibit toxic or environmentally hazardous properties. Therefore, constant monitoring of quality control is needed. In this study, we present an overview of regulatory and general methods described by various pharmacopoeias. Then, the most commonly used methodologies for the determination of residual solvents in different pharmaceutical samples are reviewed to demonstrate their limitations, which form the basis of discussion about new methods. Several interesting new alternatives for sample preparation and gas chromatography (GC) separation are presented using examples from recent studies. The techniques described are direct injection, headspace analysis with different modifications and variations, liquid extraction, single-drop microextraction, and solid-phase microextraction. Various GC separation techniques are compared and new solutions to improve sensitivity and efficiency are presented.
Keywords
LTMDVBAPILPMEIMSECDPDEGMPMHESDMEMTBEDMFFETTVTNMPb.p.N-methyl-2-pyrrolidone1,3-dimethyl-2-ImidazolidinoneFDAFull Evaporation TechniqueSPMEEHCDSCDMIPDMSDMAPTVNIRTGADMSOGC–MSN,N-DimethylacetamideN,N-dimethylformamideQA/QCElectron capture detectorflame ionization detectorILSUS Food and Drug AdministrationMultiple headspace extractionLiquid extractionBenzyl alcoholsolid-phase microextractionThermogravimetric analysisHeadspace analysisQuality assurance/quality controlLow thermal masssingle-drop microextractionSample preparation techniquesResidual solventsFIDThermal desorptiondivinylbenzeneDimethylsulfoxideAnalytical proceduresWorld Health OrganizationIntegrated Risk Information SystemFTIRMass spectrometryFourier transformation infrared spectroscopyNear-infrared spectroscopyIon mobility spectrometryIrisProcess analytical technologiesPermitted daily exposureLodIonic liquidslimit of detectionICHActive Pharmaceutical Ingredientliquid-phase microextractionBoiling pointPharmaceutical samplespatPolyacrylatePolydimethylsiloxanecarbowaxDifferential scanning calorimetryhigh-performance liquid chromatographyHPLCTwo-dimensional gas chromatographygas chromatography coupled to mass spectrometryGas chromatographyInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseWHO
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Maciej Tankiewicz, Jacek NamieÅnik, WiesÅaw Sawicki,