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Volumn 51, Issue 5, 2010, Pages 999-1014

Recent advances in trace analysis of pharmaceutical genotoxic impurities

Author keywords

Chemical derivatization; Coordination ion spray mass spectrometry; Genotoxic impurities; Matrix deactivation; Method development; Trace analysis; Unstable reactive analytes

Indexed keywords

2 CHLOROETHANOL; ALCOHOL; ALKANESULFONIC ACID DERIVATIVE; ALKYLHALIDE DERIVATIVE; CHLORBUTOL; CHLOROETHYLOXYETHANOL; EPOXIDE; FORMALDEHYDE; HALIDE; HYDRAZINE DERIVATIVE; HYDROPEROXIDE DERIVATIVE; MESYLIC ACID ETHYL ESTER; NELFINAVIR; PAZOPANIB; UNCLASSIFIED DRUG;

EID: 72749101941     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2009.11.009     Document Type: Review
Times cited : (127)

References (94)
  • 8
    • 72749108672 scopus 로고    scopus 로고
    • EMEA-CHMP, Guideline on the limit of genotoxic impurities CPMP/SWP/5199/02, EMEA/CHMP/QMP/251344/2006, 28 June, 2006.
    • EMEA-CHMP, Guideline on the limit of genotoxic impurities CPMP/SWP/5199/02, EMEA/CHMP/QMP/251344/2006, 28 June, 2006.
  • 12
    • 84889482886 scopus 로고    scopus 로고
    • Smith R.J., and Webb M.L. (Eds), Blackwell Publishing Ltd., Oxford
    • Skett P.W. In: Smith R.J., and Webb M.L. (Eds). Analysis of Drug Impurities (2007), Blackwell Publishing Ltd., Oxford 82-163
    • (2007) Analysis of Drug Impurities , pp. 82-163
    • Skett, P.W.1
  • 23
    • 72749084864 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) Guidelines, Q3C and Q3C(M): Impurities: Guideline for Residue Solvents, July 1997 and September 2002, respectively.
    • International Conference on Harmonization (ICH) Guidelines, Q3C and Q3C(M): Impurities: Guideline for Residue Solvents, July 1997 and September 2002, respectively.
  • 24
    • 72749127349 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) Guidelines, Q3A (R): Impurities in New Drug Substances (Revised Guideline), February 2002.
    • International Conference on Harmonization (ICH) Guidelines, Q3A (R): Impurities in New Drug Substances (Revised Guideline), February 2002.
  • 25
    • 72749123187 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) Guidelines, Q3B(R): Impurities in New Drug Products (Revised Guideline), February 2003.
    • International Conference on Harmonization (ICH) Guidelines, Q3B(R): Impurities in New Drug Products (Revised Guideline), February 2003.
  • 37
    • 72749105205 scopus 로고    scopus 로고
    • Analysis of pharmaceutical impurities using hydrophilic interaction liquid chromatography (HILIC)
    • P. Wang (Ed, Taylor & Francis Group in preparation
    • M. Sun, D.Q. Liu, Analysis of pharmaceutical impurities using hydrophilic interaction liquid chromatography (HILIC), in: P. Wang (Ed.), Hydrophilic Interaction Liquid Chromatography (HILIC) and Its Advanced Applications, Taylor & Francis Group (in preparation).
    • Hydrophilic Interaction Liquid Chromatography (HILIC) and Its Advanced Applications
    • Sun, M.1    Liu, D.Q.2
  • 48
    • 72749086391 scopus 로고    scopus 로고
    • M. Sun, L. Bai, G. Terfloth, D.Q. Liu, A. Kord, JPBA, JPBA-D-09-01341, doi:10.1016/j.jpba.2009.11.027.
    • M. Sun, L. Bai, G. Terfloth, D.Q. Liu, A. Kord, JPBA, JPBA-D-09-01341, doi:10.1016/j.jpba.2009.11.027.
  • 65
  • 92
    • 72749123803 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) Guidelines, Q2 (R1): Validation of Analytical Procedures (Text and Methodology), June 1995.
    • International Conference on Harmonization (ICH) Guidelines, Q2 (R1): Validation of Analytical Procedures (Text and Methodology), June 1995.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.