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3D Depth Profile Reconstruction of Segregated Impurities Using Secondary Ion Mass Spectrometry
Published on: April 29, 2020
Forced degradation and impurity profiling: recent trends in analytical perspectives.
Deepti Jain1, Pawan Kumar Basniwal
1School of Pharmaceutical Sciences, Rajiv Gandhi Technological University, Bhopal 462 033, Madhya Pradesh, India.
Journal of Pharmaceutical and Biomedical Analysis
|August 24, 2013
Summary
This review highlights pharmaceutical analysis trends from 2008-2012, focusing on degradation and impurity profiling of active pharmaceutical ingredients (APIs) and drug products using advanced analytical methods.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
Background:
- Impurity profiling and degradation analysis are critical for pharmaceutical quality control.
- Monitoring these aspects ensures drug safety and efficacy throughout their lifecycle.
Purpose of the Study:
- To review recent trends in analytical techniques for pharmaceutical degradation and impurity profiling.
- To provide a comprehensive update on methods used between 2008 and 2012.
Main Methods:
- Analysis of trends based on publication year, chromatographic conditions (columns, elution), and drug matrices.
- Focus on various analytical methods, including hyphenated techniques.
Main Results:
- Identified key trends in forced degradation and impurity profiling over the 2008-2012 period.
- Detailed the application of chromatographic and hyphenated techniques for impurity identification and quantification.
Conclusions:
- Analytical perspectives in pharmaceutical degradation and impurity profiling have evolved significantly.
- Advanced methods are crucial for accurately identifying and quantifying impurities in diverse pharmaceutical matrices.
Keywords:
(1)H NMR(13)C NMR1,1,1,3,3,3-hexafluoroisopropanol1,1,2-trichloro ethane13 carbon nuclear magnetic resonance spectroscopy1D/2D NMR3,4-methylenedioxy-N-methylamphetamineAAMRTACNAPCI-MSAPIAnalytical perspectivesBADGEBEHC(6)H(6)CADCCDCCl(4)CECEADCH(2)Cl(2)CH(3)COONH(4)CHCl(2)CH(2)ClCHCl(3)CIDCO(2)COPDDAD/MSDEPTDrug productsEDTAELSDEMEAESI-CID-MS/MSESI-FTICR-MSESI/MS(n)European agency for the evaluation of medicinal productsFT-IRFTICRForced degradation profilingFourier transform infraredFourier transform ion cyclotron resonanceGC-FIDGC–MSGFCGTIsH(2)OH(3)PO(4)HCOOHHCOONH(4)HClHEIPHILICHP-SECHPAE-IPADHPLCHPLC/ESI-MSHPTLCICHIFMINDIPAImpurityInternational Conference on HarmonizationK(2)HPO(4)KH(2)PO(4)KOHLC/MS/MSLC–ESI-MS(n)LC–ESI-QT/MS/MSLC–MSLiClMDMAMECCMEKCMPLCMPTPMSMeOHN-methyl-4-phenyl-1,2,3,6-tetrahydropyridineNDANH(3)NH(4)H(2)PO(4)NH(4)OHNOESYNSAIDsNa(2)HPO(4)Na(3)PO(4)NaClNew Drug ApplicationOVIsPCAPDAPDA-MSPFPAQ-TOFRIRRFSDSSDS-PAGESFCSPMETEATFATrisUPLCUS Food and Drug AdministrationUSFDAacetonitrileactive pharmaceutical ingredientammoniaammonium acetateammonium dihydrogen phosphateammonium formateammonium hydroxideatmospheric-pressure chemical-ionization mass spectrometryauto-associative multivariate regression treesbenzenebisphenol A diglycidyl etherbridged ethylene hybridcapillary electrophoresiscarbon dioxidecentral composite designcharged aerosol detectorchloroformchronic obstructive pulmonary diseasecollision-induced dissociationcoulometric electrode array detectiondiode array detector-mass spectrometrydipotassium hydrogen phosphatedisodium phosphatedistortionless enhancement by polarization transferelectronspray ionization multi-stage or tandem mass spectrometryelectrospray ionization Fourier transform ion cyclotron resonance mass spectrometryelectrospray ionization, collision-induced dissociation and tandem mass spectrometryethylene diamine tetra acetic acidevaporative light scattering detectorformic acidgas chromatography-flame ionization detectorgas chromatography–mass spectrometrygel filtration chromatographygenotoxic impuritiesheadspace solid phase microextractionhigh performance liquid chromatographyhigh performance thin layer chromatographyhigh-performance anion-exchange chromatography-integrated pulsed amperometric detectionhigh-performance liquid chromatography/electrospray ionization mass spectrometryhigh-performance size-exclusion chromatographyhydrochloric acidhydrophilic interaction chromatographyimpurity fate mappinginvestigational new drugsisoproyl alcoholliquid chromatography–electro spray ionization-tandem mass spectrometerliquid chromatography–mass spectrometryliquid chromatography–tandem mass spectrometryliquid chromatography–tandem mass spectrometry using electrospray ionization source and Q-trap mass analyzerlithium chloridemass spectrometrymedium pressure liquid chromatographymethanolmethylene chloridemicellar electrokinetic capillary chromatographymicellar electrokinetic chromatographynon-steroidal anti-inflammatory drugsnuclear overhauser effect spectroscopyone dimensional/two dimensional nuclear magnetic resonanceorganic volatile impuritiespentafluoropropionic acid anhydridephosphoric acidphotodiode arrayphotodiode array detector-mass spectrometrypotassium dihydrogen phosphatepotassium hydroxideprincipal component analysisproton nuclear magnetic resonance spectroscopyquadrupole-time-of-flightrefractive indexrelative response factorsodium chloridesodium dodecyl sulfatesodium dodecyl sulfate polyacrylamide gel electrophoresissodium phosphatesupercritical fluid chromatographytetrachloromethanetriethylaminetrifluoroacetic acidtrisaminomethaneultra performance liquid chromatographywaterMore Related Videos
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