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

التفاصيل البيبلوغرافية
العنوان:	Critical practical aspects in the application of liquid chromatography-mass spectrometric studies for the characterization of impurities and degradation products.
المؤلفون:	Narayanam M; Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar 160062, Punjab, India., Handa T, Sharma P, Jhajra S, Muthe PK, Dappili PK, Shah RP, Singh S
المصدر:	Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2014 Jan; Vol. 87, pp. 191-217. Date of Electronic Publication: 2013 Apr 28.
نوع المنشور:	Journal Article; Review
اللغة:	English
بيانات الدورية:	Publisher: Elsevier Science Country of Publication: England NLM ID: 8309336 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-264X (Electronic) Linking ISSN: 07317085 NLM ISO Abbreviation: J Pharm Biomed Anal Subsets: MEDLINE
أسماء مطبوعة:	Publication: <2006->: London : Elsevier Science Original Publication: Oxford ; New York : Pergamon Press, c1983-
مواضيع طبية MeSH:	Chromatography, Liquid/methods , Mass Spectrometry/methods , Pharmaceutical Preparations/*analysis, Drug Contamination ; Pharmaceutical Preparations/chemistry ; Pharmaceutical Preparations/standards
مستخلص:	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. (Copyright © 2013 Elsevier B.V. All rights reserved.)
فهرسة مساهمة:	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
المشرفين على المادة:	0 (Pharmaceutical Preparations)
تواريخ الأحداث:	Date Created: 20130528 Date Completed: 20140829 Latest Revision: 20131209
رمز التحديث:	20221213
DOI:	10.1016/j.jpba.2013.04.027
PMID:	23706957
قاعدة البيانات:	MEDLINE

View record from ScienceDirect

Full Text Finder

الوصف
تدمد:	1873-264X
DOI:	10.1016/j.jpba.2013.04.027