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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.

Titel:	Critical practical aspects in the application of liquid chromatography-mass spectrometric studies for the characterization of impurities and degradation products.
Autor/in / Beteiligte Person:	Narayanam, M ; Handa, T ; Sharma, P ; Jhajra, S ; Muthe, PK ; Dappili, PK ; Shah, RP ; Singh, S
Zeitschrift:	Journal of pharmaceutical and biomedical analysis, Jg. 87 (2014), S. 191-217
Veröffentlichung:	<2006->: London : Elsevier Science ; <i>Original Publication</i>: Oxford ; New York : Pergamon Press, c1983-, 2014
Medientyp:	academicJournal
ISSN:	1873-264X (electronic)
DOI:	10.1016/j.jpba.2013.04.027
Schlagwort:	Drug Contamination Pharmaceutical Preparations chemistry Pharmaceutical Preparations standards Chromatography, Liquid methods Mass Spectrometry methods Pharmaceutical Preparations analysis
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Review Language: English [J Pharm Biomed Anal] 2014 Jan; Vol. 87, pp. 191-217. <i>Date of Electronic Publication: </i>2013 Apr 28. MeSH Terms: Chromatography, Liquid / methods ; Mass Spectrometry / methods ; Pharmaceutical Preparations / *analysis ; Drug Contamination ; Pharmaceutical Preparations / chemistry ; Pharmaceutical Preparations / standards Contributed Indexing: Keywords: (4-hydrazino-4-oxobutyl) tris(2,4,6-trimethoxyphenyl) phosphonium bromide; 1,2-dimethylimidazole-4-sulfonyl; 1-(2,4-dinitro-5-fluorophenyl)-4-methylpiperazine; 1-(carboxymethyl) pyridium chloride hydrazide; 1-(carboxymethyl) trimethylammonium chloride hydrazide; 2,2,2-trifluoroethanol; 2,2′-azobis(2-amidinopropane) dihydrochloride; 2,4-dinitrophenylhydrazine; 2-(N,N-dimethyl-amino) ethyl acrylate; 2-MeTHF; 2-acrylamino-2-methyl-propanesulfonic acid; 2-hydrazino-1-methyl-pyridine; 2-hydrazinopyridine; 2-methyltetrahydrofuran; 2-nitro-4-trifluoromethylphenylhydrazine; 2-nitrobenzaldehyde; 2NFP-APB; 4-(1H-pyrazol-1-yl) benzenesulfonyl; 4-(2-((4-bromophenethyl) dimethylammonio) ethoxy) benzenaminium dibromide; 4-(4-methyl-1-piperazyl)-3-nitrobenzoyl azide; 4-(4-nitrophenyl)-1,2,4-triazoline-3,5-dione; 4-(trimethylammonium) anilyl-N-hydroxysuccidimidyl carbamate iodide; 4-APEBA; 4-[2-(6,7-dimethoxy-4-methyl-3-oxo-3,4-dihydroquinoxalyl)ethyl]-1,2,4-triazoline-3,5-dione; 4-[2-(N,N-dimethylamino) ethylaminosulfonyl]-7-(2-aminoethylamino)-2,1,3-benzoxadiazole; 4-[2-(N,N-dimethylamino) ethylaminosulfonyl]-7-N-methylhydrazino-2,1,3-benzoxadiazole; 4-[4-(6-methoxy-2-benzoxazolyl) phenyl]-1,2,4-triazoline-3,5-dione; 4-bromomethyl-7-methoxycoumarin; 4-nitro-7-piperazion-2,1,3-benzoxadiazole; 7-chloro-4-nitro-2,1,3-benzoxadiazole; 7-fluoro-4-nitro-2,1,3-benzoxadiazole; AAPH; ACN; AIBN; AMDSA; APCI; API; APPI; APZ; BMC; CHEFOG; CID; Characterization; DAABD-AE; DAABD-MHz; DAPB; DBA; DCU; DFT; DIPEA; DMAE; DMAP; DMEQTAD; DMF; DMIS; DMSO; DNPH; DPs; Da; Dalton; Degradation products; Dns-Cl; Dns-Hz; ESI; ESI-MS; ESI-MS/TOF; FT-ICR; GirP; GirT; H/D; HILIC; HMP; HP; HPLC; HRMS; IHD; IMPs; IR; IUPAC; Impurities; International Union of Pure and Applied Chemistry; LC; LC-ESI-MS; LC–MS; LOQ; MBOTAD; MDMAES; MNBDH; MS; MS(n); MS-TOF; N-methyl-4-hydrazino-7-nitrobenzofurazan; NA; NBA; NBD-Cl; NBD-F; NBDPZ; NFPH; NH(4)OH; NIT; NMR; NPTAD; NSAIDs; PABA; PAHs; PBS; PFB-Br; PFPA; PGF2α; PPZ; PS; Practical aspects; Q-TOF; RDB; RP-HPLC; S-pentafluorophenyl tris(2,4,6-trimethoxyphenyl) phosphonium acetate bromide; SRM; Strategy; TFA; TFE; THAS; THF; TMAE; TMPP; TMPP-AcPFP; TMPP-PrG; TOF; TSH; UV; X-ray Diffraction; XRD; [3-(2-nitro-4-trifluoromethylphenyl) aminophenyl] dihydroxyborane; [M+H](+); acetonitrile; ammonium hydroxide; atmospheric pressure chemical ionization; atmospheric pressure ionization; atmospheric pressure photoionization; azobisisobutyronitrile; chemical formula generator; collision-induced dissociation; dansyl chloride; dansyl hydrazine; dansyl-3-aminophenylboronic acid; degradation products; density functional theory; di-n-butyl amine; dicyclohexyl urea; diisopropylethylamine; dimethyl amino pyridine; dimethyl sulfoxide; dimethylformamide; electrospray ionization; electrospray ionization mass spectrometry/time of flight; electrospray ionization-mass spectrometry; fourier transform-ion cyclotron resonance; high performance liquid chromatography; high resolution mass spectrometry; hydrogen/deuterium; hydrophilic interaction liquid chromatography; impurities; index of hydrogen deficiency; infrared; isonicotinoyl azide; limit of quantification; liquid chromatography; liquid chromatography-electrospray ionization-mass spectrometry; liquid chromatography–mass spectrometry; mM; mass spectrometry; mass spectrometry-time of flight; milli mass unit; millimolar; mmu; molecular ion; mono(dimethylaminoethyl) succinyl imidazolide; multi stage mass spectrometry; naphthylisothiocyanate; non-steroidal anti-inflammatory drugs; nuclear magnetic resonance; p-toluenesulfonylhydrazide; para-amino benzoic acid; parts per million; pentafluorobenzyl bromide; pentafluoropropionic acid anhydride; polycyclic aromatic hydrocarbons; ppm; prostaglandin F2α; pyridine-3-sulfonyl; quadrupole-time of flight; reversed phase-high performance liquid chromatography; ring plus double bonds; selected reaction monitoring; tetrahydrofuran; time of flight; trifluoroacetic acid; trimethyl amino-ethylalcohol; tris(2,4,6-trimethoxyphenyl) phosphine; ultra violet Substance Nomenclature: 0 (Pharmaceutical Preparations) Entry Date(s): Date Created: 20130528 Date Completed: 20140829 Latest Revision: 20131209 Update Code: 20240513

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Critical practical aspects in the application of liquid chromatography-mass spectrometric studies for the characterization of impurities and degradation products.