TY - JOUR T1 - Critical practical aspects in the application of liquid chromatography-mass spectrometric studies for the characterization of impurities and degradation products. AU - Narayanam,Mallikarjun, AU - Handa,Tarun, AU - Sharma,Parul, AU - Jhajra,Shalu, AU - Muthe,Praveen Kumar, AU - Dappili,Pavan Kumar, AU - Shah,Ravi P, AU - Singh,Saranjit, Y1 - 2013/04/28/ PY - 2013/04/10/received PY - 2013/04/18/accepted PY - 2013/5/28/entrez PY - 2013/5/28/pubmed PY - 2014/8/30/medline KW - (4-hydrazino-4-oxobutyl) tris(2,4,6-trimethoxyphenyl) phosphonium bromide KW - 1,2-dimethylimidazole-4-sulfonyl KW - 1-(2,4-dinitro-5-fluorophenyl)-4-methylpiperazine KW - 1-(carboxymethyl) pyridium chloride hydrazide KW - 1-(carboxymethyl) trimethylammonium chloride hydrazide KW - 2,2,2-trifluoroethanol KW - 2,2′-azobis(2-amidinopropane) dihydrochloride KW - 2,4-dinitrophenylhydrazine KW - 2-(N,N-dimethyl-amino) ethyl acrylate KW - 2-MeTHF KW - 2-acrylamino-2-methyl-propanesulfonic acid KW - 2-hydrazino-1-methyl-pyridine KW - 2-hydrazinopyridine KW - 2-methyltetrahydrofuran KW - 2-nitro-4-trifluoromethylphenylhydrazine KW - 2-nitrobenzaldehyde KW - 2NFP-APB KW - 4-(1H-pyrazol-1-yl) benzenesulfonyl KW - 4-(2-((4-bromophenethyl) dimethylammonio) ethoxy) benzenaminium dibromide KW - 4-(4-methyl-1-piperazyl)-3-nitrobenzoyl azide KW - 4-(4-nitrophenyl)-1,2,4-triazoline-3,5-dione KW - 4-(trimethylammonium) anilyl-N-hydroxysuccidimidyl carbamate iodide KW - 4-APEBA KW - 4-[2-(6,7-dimethoxy-4-methyl-3-oxo-3,4-dihydroquinoxalyl)ethyl]-1,2,4-triazoline-3,5-dione KW - 4-[2-(N,N-dimethylamino) ethylaminosulfonyl]-7-(2-aminoethylamino)-2,1,3-benzoxadiazole KW - 4-[2-(N,N-dimethylamino) ethylaminosulfonyl]-7-N-methylhydrazino-2,1,3-benzoxadiazole KW - 4-[4-(6-methoxy-2-benzoxazolyl) phenyl]-1,2,4-triazoline-3,5-dione KW - 4-bromomethyl-7-methoxycoumarin KW - 4-nitro-7-piperazion-2,1,3-benzoxadiazole KW - 7-chloro-4-nitro-2,1,3-benzoxadiazole KW - 7-fluoro-4-nitro-2,1,3-benzoxadiazole KW - AAPH KW - ACN KW - AIBN KW - AMDSA KW - APCI KW - API KW - APPI KW - APZ KW - BMC KW - CHEFOG KW - CID KW - Characterization KW - DAABD-AE KW - DAABD-MHz KW - DAPB KW - DBA KW - DCU KW - DFT KW - DIPEA KW - DMAE KW - DMAP KW - DMEQTAD KW - DMF KW - DMIS KW - DMSO KW - DNPH KW - DPs KW - Da KW - Dalton KW - Degradation products KW - Dns-Cl KW - Dns-Hz KW - ESI KW - ESI-MS KW - ESI-MS/TOF KW - FT-ICR KW - GirP KW - GirT KW - H/D KW - HILIC KW - HMP KW - HP KW - HPLC KW - HRMS KW - IHD KW - IMPs KW - IR KW - IUPAC KW - Impurities KW - International Union of Pure and Applied Chemistry KW - LC KW - LC-ESI-MS KW - LC–MS KW - LOQ KW - MBOTAD KW - MDMAES KW - MNBDH KW - MS KW - MS(n) KW - MS-TOF KW - N-methyl-4-hydrazino-7-nitrobenzofurazan KW - NA KW - NBA KW - NBD-Cl KW - NBD-F KW - NBDPZ KW - NFPH KW - NH(4)OH KW - NIT KW - NMR KW - NPTAD KW - NSAIDs KW - PABA KW - PAHs KW - PBS KW - PFB-Br KW - PFPA KW - PGF2α KW - PPZ KW - PS KW - Practical aspects KW - Q-TOF KW - RDB KW - RP-HPLC KW - S-pentafluorophenyl tris(2,4,6-trimethoxyphenyl) phosphonium acetate bromide KW - SRM KW - Strategy KW - TFA KW - TFE KW - THAS KW - THF KW - TMAE KW - TMPP KW - TMPP-AcPFP KW - TMPP-PrG KW - TOF KW - TSH KW - UV KW - X-ray Diffraction KW - XRD KW - [3-(2-nitro-4-trifluoromethylphenyl) aminophenyl] dihydroxyborane KW - [M+H](+) KW - acetonitrile KW - ammonium hydroxide KW - atmospheric pressure chemical ionization KW - atmospheric pressure ionization KW - atmospheric pressure photoionization KW - azobisisobutyronitrile KW - chemical formula generator KW - collision-induced dissociation KW - dansyl chloride KW - dansyl hydrazine KW - dansyl-3-aminophenylboronic acid KW - degradation products KW - density functional theory KW - di-n-butyl amine KW - dicyclohexyl urea KW - diisopropylethylamine KW - dimethyl amino pyridine KW - dimethyl sulfoxide KW - dimethylformamide KW - electrospray ionization KW - electrospray ionization mass spectrometry/time of flight KW - electrospray ionization-mass spectrometry KW - fourier transform-ion cyclotron resonance KW - high performance liquid chromatography KW - high resolution mass spectrometry KW - hydrogen/deuterium KW - hydrophilic interaction liquid chromatography KW - impurities KW - index of hydrogen deficiency KW - infrared KW - isonicotinoyl azide KW - limit of quantification KW - liquid chromatography KW - liquid chromatography-electrospray ionization-mass spectrometry KW - liquid chromatography–mass spectrometry KW - mM KW - mass spectrometry KW - mass spectrometry-time of flight KW - milli mass unit KW - millimolar KW - mmu KW - molecular ion KW - mono(dimethylaminoethyl) succinyl imidazolide KW - multi stage mass spectrometry KW - naphthylisothiocyanate KW - non-steroidal anti-inflammatory drugs KW - nuclear magnetic resonance KW - p-toluenesulfonylhydrazide KW - para-amino benzoic acid KW - parts per million KW - pentafluorobenzyl bromide KW - pentafluoropropionic acid anhydride KW - polycyclic aromatic hydrocarbons KW - ppm KW - prostaglandin F2α KW - pyridine-3-sulfonyl KW - quadrupole-time of flight KW - reversed phase-high performance liquid chromatography KW - ring plus double bonds KW - selected reaction monitoring KW - tetrahydrofuran KW - time of flight KW - trifluoroacetic acid KW - trimethyl amino-ethylalcohol KW - tris(2,4,6-trimethoxyphenyl) phosphine KW - ultra violet SP - 191 EP - 217 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 87 N2 - Liquid chromatography-mass spectrometry (LC-MS) is considered today as a mainstay tool for the structure characterization of minor components like impurities (IMPs) and degradation products (DPs) in drug substances and products. A multi-step systematic strategy for the purpose involves high resolution mass and multi-stage mass studies on both the drug and IMPs/DPs, followed by comparison of their fragmentation profiles. Its successful application requires consideration of many practical aspects at each step. The same are critically discussed in this review. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/23706957/Critical_practical_aspects_in_the_application_of_liquid_chromatography_mass_spectrometric_studies_for_the_characterization_of_impurities_and_degradation_products_ DB - PRIME DP - Unbound Medicine ER -