TY - JOUR T1 - Forced degradation and impurity profiling: recent trends in analytical perspectives. AU - Jain,Deepti, AU - Basniwal,Pawan Kumar, Y1 - 2013/07/31/ PY - 2013/05/09/received PY - 2013/06/28/revised PY - 2013/07/07/accepted PY - 2013/8/24/entrez PY - 2013/8/24/pubmed PY - 2014/5/27/medline KW - (1)H NMR KW - (13)C NMR KW - 1,1,1,3,3,3-hexafluoroisopropanol KW - 1,1,2-trichloro ethane KW - 13 carbon nuclear magnetic resonance spectroscopy KW - 1D/2D NMR KW - 3,4-methylenedioxy-N-methylamphetamine KW - AAMRT KW - ACN KW - APCI-MS KW - API KW - Analytical perspectives KW - BADGE KW - BEH KW - C(6)H(6) KW - CAD KW - CCD KW - CCl(4) KW - CE KW - CEAD KW - CH(2)Cl(2) KW - CH(3)COONH(4) KW - CHCl(2)CH(2)Cl KW - CHCl(3) KW - CID KW - CO(2) KW - COPD KW - DAD/MS KW - DEPT KW - Drug products KW - EDTA KW - ELSD KW - EMEA KW - ESI-CID-MS/MS KW - ESI-FTICR-MS KW - ESI/MS(n) KW - European agency for the evaluation of medicinal products KW - FT-IR KW - FTICR KW - Forced degradation profiling KW - Fourier transform infrared KW - Fourier transform ion cyclotron resonance KW - GC-FID KW - GC–MS KW - GFC KW - GTIs KW - H(2)O KW - H(3)PO(4) KW - HCOOH KW - HCOONH(4) KW - HCl KW - HEIP KW - HILIC KW - HP-SEC KW - HPAE-IPAD KW - HPLC KW - HPLC/ESI-MS KW - HPTLC KW - ICH KW - IFM KW - IND KW - IPA KW - Impurity KW - International Conference on Harmonization KW - K(2)HPO(4) KW - KH(2)PO(4) KW - KOH KW - LC/MS/MS KW - LC–ESI-MS(n) KW - LC–ESI-QT/MS/MS KW - LC–MS KW - LiCl KW - MDMA KW - MECC KW - MEKC KW - MPLC KW - MPTP KW - MS KW - MeOH KW - N-methyl-4-phenyl-1,2,3,6-tetrahydropyridine KW - NDA KW - NH(3) KW - NH(4)H(2)PO(4) KW - NH(4)OH KW - NOESY KW - NSAIDs KW - Na(2)HPO(4) KW - Na(3)PO(4) KW - NaCl KW - New Drug Application KW - OVIs KW - PCA KW - PDA KW - PDA-MS KW - PFPA KW - Q-TOF KW - RI KW - RRF KW - SDS KW - SDS-PAGE KW - SFC KW - SPME KW - TEA KW - TFA KW - Tris KW - UPLC KW - US Food and Drug Administration KW - USFDA KW - acetonitrile KW - active pharmaceutical ingredient KW - ammonia KW - ammonium acetate KW - ammonium dihydrogen phosphate KW - ammonium formate KW - ammonium hydroxide KW - atmospheric-pressure chemical-ionization mass spectrometry KW - auto-associative multivariate regression trees KW - benzene KW - bisphenol A diglycidyl ether KW - bridged ethylene hybrid KW - capillary electrophoresis KW - carbon dioxide KW - central composite design KW - charged aerosol detector KW - chloroform KW - chronic obstructive pulmonary disease KW - collision-induced dissociation KW - coulometric electrode array detection KW - diode array detector-mass spectrometry KW - dipotassium hydrogen phosphate KW - disodium phosphate KW - distortionless enhancement by polarization transfer KW - electronspray ionization multi-stage or tandem mass spectrometry KW - electrospray ionization Fourier transform ion cyclotron resonance mass spectrometry KW - electrospray ionization, collision-induced dissociation and tandem mass spectrometry KW - ethylene diamine tetra acetic acid KW - evaporative light scattering detector KW - formic acid KW - gas chromatography-flame ionization detector KW - gas chromatography–mass spectrometry KW - gel filtration chromatography KW - genotoxic impurities KW - headspace solid phase microextraction KW - high performance liquid chromatography KW - high performance thin layer chromatography KW - high-performance anion-exchange chromatography-integrated pulsed amperometric detection KW - high-performance liquid chromatography/electrospray ionization mass spectrometry KW - high-performance size-exclusion chromatography KW - hydrochloric acid KW - hydrophilic interaction chromatography KW - impurity fate mapping KW - investigational new drugs KW - isoproyl alcohol KW - liquid chromatography–electro spray ionization-tandem mass spectrometer KW - liquid chromatography–mass spectrometry KW - liquid chromatography–tandem mass spectrometry KW - liquid chromatography–tandem mass spectrometry using electrospray ionization source and Q-trap mass analyzer KW - lithium chloride KW - mass spectrometry KW - medium pressure liquid chromatography KW - methanol KW - methylene chloride KW - micellar electrokinetic capillary chromatography KW - micellar electrokinetic chromatography KW - non-steroidal anti-inflammatory drugs KW - nuclear overhauser effect spectroscopy KW - one dimensional/two dimensional nuclear magnetic resonance KW - organic volatile impurities KW - pentafluoropropionic acid anhydride KW - phosphoric acid KW - photodiode array KW - photodiode array detector-mass spectrometry KW - potassium dihydrogen phosphate KW - potassium hydroxide KW - principal component analysis KW - proton nuclear magnetic resonance spectroscopy KW - quadrupole-time-of-flight KW - refractive index KW - relative response factor KW - sodium chloride KW - sodium dodecyl sulfate KW - sodium dodecyl sulfate polyacrylamide gel electrophoresis KW - sodium phosphate KW - supercritical fluid chromatography KW - tetrachloromethane KW - triethylamine KW - trifluoroacetic acid KW - trisaminomethane KW - ultra performance liquid chromatography KW - water SP - 11 EP - 35 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 86 N2 - This review describes an epigrammatic impression of the recent trends in analytical perspectives of degradation and impurities profiling of pharmaceuticals including active pharmaceutical ingredient (API) as well as drug products during 2008-2012. These recent trends in forced degradation and impurity profiling were discussed on the head of year of publication; columns, matrix (API and dosage forms) and type of elution in chromatography (isocratic and gradient); therapeutic categories of the drug which were used for analysis. It focuses distinctly on comprehensive update of various analytical methods including hyphenated techniques for the identification and quantification of thresholds of impurities and degradants in different pharmaceutical matrices. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/23969330/Forced_degradation_and_impurity_profiling:_recent_trends_in_analytical_perspectives_ DB - PRIME DP - Unbound Medicine ER -