A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products
作者： Saranjit Singh , Tarun Handa , Mallikarjun Narayanam , Archana Sahu , Mahendra Junwal
DOI: 10.1016/J.JPBA.2012.03.044
关键词: Chemistry 、 Spectral analysis 、 Chromatography 、 Data interpretation 、 Genotoxic impurities 、 Biochemical engineering
摘要: … control of impurities (IMPs) and degradation products (DPs) (including genotoxic impurities) in … for application of hyphenated tools in impurity and degradation product profiling of small …
elsevier.com
sci-hub.se 参考文章(227)
Sunny Piyush Bhardwaj, Saranjit Singh, Study of forced degradation behavior of enalapril maleate by LC and LC–MS and development of a validated stability-indicating assay method Journal of Pharmaceutical and Biomedical Analysis. ,vol. 46, pp. 113- 120 ,(2008) , 10.1016/J.JPBA.2007.09.014
Aurélie Vassort, Paul Nicholas Shaw, Paul D. Ferguson, Roman Szücs, David A. Barrett, Comparison of CZE, open-tubular CEC and non-aqueous CE coupled to electrospray MS for impurity profiling of drugs. Electrophoresis. ,vol. 29, pp. 3563- 3574 ,(2008) , 10.1002/ELPS.200700769
Steven W. Baertschi, Douglas E. Dorman, John L. Occolowitz, Monte W. Collins, Larry A. Spangle, Gregory A. Stephenson, Leslie J. Lorenz, Isolation and structure elucidation of the major degradation products of cefaclor formed under aqueous acidic conditions Journal of Pharmaceutical Sciences. ,vol. 86, pp. 526- 539 ,(1997) , 10.1021/JS960427X
Anton Pozniak, Lutz Muller, Miklos Salgo, Judith K Jones, Peter Larson, David Tweats, Elevated ethyl methanesulfonate (EMS) in nelfinavir mesylate (Viracept, Roche): overview. Aids Research and Therapy. ,vol. 6, pp. 18- 18 ,(2009) , 10.1186/1742-6405-6-18
Stephen W. Holman, Patricia Wright, Neil J. Wells, G. John Langley, Evidence for site-specific intra-ionic hydrogen/deuterium exchange in the low-energy collision-induced dissociation product ion spectra of protonated small molecules generated by electrospray ionisation. Journal of Mass Spectrometry. ,vol. 45, pp. 347- 357 ,(2010) , 10.1002/JMS.1714
Chi-Yu Lu, Chia-Hsien Feng, Identification of dimer impurities in ampicillin and amoxicillin by capillary LC and tandem mass spectrometry. Journal of Separation Science. ,vol. 30, pp. 329- 332 ,(2007) , 10.1002/JSSC.200600362
Patrik Petersson, Magnus Jörntén-Karlsson, Maria Stålebro, Direct coupling of micellar electrokinetic chromatography to mass spectrometry using a volatile buffer system based on perfluorooctanoic acid and ammonia. Electrophoresis. ,vol. 24, pp. 999- 1007 ,(2003) , 10.1002/ELPS.200390144
Ira S. Krull, John D. Orr, Michael E. Swartz, Validation of Impurity Methods, Part I Lc Gc North America. ,vol. 21, pp. 1146- 1152 ,(2003)
Andreas Körner, Uncovering deficiencies in mass balance using HPLC with chemiluminescence nitrogen-specific detection Lc Gc North America. ,vol. 20, pp. 364- 373 ,(2002)
Gerhardus J. De Jong, Cas Van Den Beld, Thijs K. Gerding, Silke Klick, Alexander J. Debets, Pim G. Muijselaar, Cari Sänger-Van De Griend, Christian Korn, Thomas Eichinger, Joop Waterval, Govert W. Somsen, Toward a generic approach for: Stress testing of drug substances and drug products Pharmaceutical technology. ,vol. 29, pp. 48- 66 ,(2005)