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Volumn 27, Issue 2, 2009, Pages

Genotoxic and non-genotoxic Impurities in pharmaceuticals current regulations, status and trend

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EID: 67649878788     PISSN: 0392839X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (5)

References (18)
  • 1
    • 67649854959 scopus 로고    scopus 로고
    • www.fda.gov/cder
  • 2
    • 67649846339 scopus 로고    scopus 로고
    • www.ich.org
  • 3
    • 67649863585 scopus 로고    scopus 로고
    • www.emea.europa.eu
  • 4
    • 49449091670 scopus 로고    scopus 로고
    • Genotoxic Impurities : A Quantitative Approach
    • Z. Y. Yuabova et al., "Genotoxic Impurities : A Quantitative Approach", J. Liq. Chromatogr. Related Technol., 31 (15), pp. 2318-2330 (2008).
    • (2008) J. Liq. Chromatogr. Related Technol , vol.31 , Issue.15 , pp. 2318-2330
    • Yuabova, Z.Y.1
  • 5
    • 67649854958 scopus 로고    scopus 로고
    • www.emea.eu.int (document id: CPMP/SWP/5 1 99/02; EMEA/CHMP/QWP/251344/ 2006)
    • www.emea.eu.int (document id: CPMP/SWP/5 1 99/02; EMEA/CHMP/QWP/251344/ 2006)
  • 6
    • 33645840463 scopus 로고    scopus 로고
    • A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity
    • L. Mueller et al., "A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity", Regul. Toxicol. Pharm., 44 (3), pp. 198-211 (2006).
    • (2006) Regul. Toxicol. Pharm , vol.44 , Issue.3 , pp. 198-211
    • Mueller, L.1
  • 7
    • 33747890096 scopus 로고    scopus 로고
    • Regulation of genotoxic and carcinogenic impurities in drug substances and products, TrAC
    • T. McGovern et al., "Regulation of genotoxic and carcinogenic impurities in drug substances and products", TrAC, Trends in Analytical Chemistry, 25 (8), pp. 790-795 (2006).
    • (2006) Trends in Analytical Chemistry , vol.25 , Issue.8 , pp. 790-795
    • McGovern, T.1
  • 8
    • 50649100669 scopus 로고    scopus 로고
    • Drug safety, drug quality, drug analysis
    • S. Gorog, "Drug safety, drug quality, drug analysis", J. Pharm. Biomed. Anal., 48 (2), pp. 247-253 (2008).
    • (2008) J. Pharm. Biomed. Anal , vol.48 , Issue.2 , pp. 247-253
    • Gorog, S.1
  • 9
    • 33947128696 scopus 로고    scopus 로고
    • Identification of pharmaceutical impurities
    • F. Qiu et al., "Identification of pharmaceutical impurities", J. Liq. Chromatogr. Related Technol., 30 (5-7), pp. 877-935 (2007).
    • (2007) J. Liq. Chromatogr. Related Technol , vol.30 , Issue.5-7 , pp. 877-935
    • Qiu, F.1
  • 10
    • 33846794634 scopus 로고    scopus 로고
    • Pharmaceutical impurities : Regulatory perspective for Abbreviated New Drug Applications
    • A. K. Basak et al., "Pharmaceutical impurities : Regulatory perspective for Abbreviated New Drug Applications", Adv. Drug Delivery Rev., 59 (1), pp. 64-72 (2007).
    • (2007) Adv. Drug Delivery Rev , vol.59 , Issue.1 , pp. 64-72
    • Basak, A.K.1
  • 11
    • 33947249054 scopus 로고    scopus 로고
    • Applications of LC/MS in structure identifications of small molecules and proteins in drug discovery
    • G. Chen et al., "Applications of LC/MS in structure identifications of small molecules and proteins in drug discovery", J. Mass Spectrom., 42 (3), pp. 279-287 (2007).
    • (2007) J. Mass Spectrom , vol.42 , Issue.3 , pp. 279-287
    • Chen, G.1
  • 12
    • 33747875755 scopus 로고    scopus 로고
    • The changing role of NMR spectroscopy in offline impurity identification: A conceptual view, TrAC
    • C. Szantay et al., "The changing role of NMR spectroscopy in offline impurity identification: A conceptual view", TrAC, Trends in Analytical Chemistry, 25 (8), pp. 806-820 (2006).
    • (2006) Trends in Analytical Chemistry , vol.25 , Issue.8 , pp. 806-820
    • Szantay, C.1
  • 13
    • 34249948356 scopus 로고    scopus 로고
    • On-line H/D exchange LC-MS strategy for structural elucidation of pharmaceutical impurities
    • D. Q. Liu et al., "On-line H/D exchange LC-MS strategy for structural elucidation of pharmaceutical impurities", J. Pharm. Biomed. Anal., 44 (2), pp. 320-329 (2007).
    • (2007) J. Pharm. Biomed. Anal , vol.44 , Issue.2 , pp. 320-329
    • Liu, D.Q.1
  • 14
    • 58149331918 scopus 로고    scopus 로고
    • Preparative isolation of impurities
    • G. Terfloth, "Preparative isolation of impurities", Analysis of Drug Impurities, pp. 215-234 (2007).
    • (2007) Analysis of Drug Impurities , pp. 215-234
    • Terfloth, G.1
  • 15
    • 53049088565 scopus 로고    scopus 로고
    • A practical derivatization LC/MS approach for determination of trace level alkyl sulfonates and dialkyl sulfates genotoxic impurities in drug substances
    • J. An et al., "A practical derivatization LC/MS approach for determination of trace level alkyl sulfonates and dialkyl sulfates genotoxic impurities in drug substances", J. Pharm. Biomed. Anal., 48 (3), pp. 1006-1010 (2008).
    • (2008) J. Pharm. Biomed. Anal , vol.48 , Issue.3 , pp. 1006-1010
    • An, J.1
  • 16
    • 53349098836 scopus 로고    scopus 로고
    • Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients
    • D. P. Elder et al., "Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients", J. Pharm. Biomed. Anal., 48 (3), 497-507 (2008).
    • (2008) J. Pharm. Biomed. Anal , vol.48 , Issue.3 , pp. 497-507
    • Elder, D.P.1
  • 17
    • 49949110106 scopus 로고    scopus 로고
    • Development and validation of RP-HPLC method for the determination of genotoxic alkyl benzenesulfonates in amlodipine besylate
    • N. V. V. S. S. Raman, et al., "Development and validation of RP-HPLC method for the determination of genotoxic alkyl benzenesulfonates in amlodipine besylate", J. Pharm. Biomed. Anal., 48 (1), pp. 227-230 (2008).
    • (2008) J. Pharm. Biomed. Anal , vol.48 , Issue.1 , pp. 227-230
    • Raman, N.V.V.S.S.1
  • 18
    • 49449091670 scopus 로고    scopus 로고
    • Genotoxic Impurities : A Quantitative Approach
    • Z. Y. Yuabova et al., "Genotoxic Impurities : A Quantitative Approach", J. Liq. Chromatogr. Related Technol., 31 (15), pp. 2318-2330 (2008).
    • (2008) J. Liq. Chromatogr. Related Technol , vol.31 , Issue.15 , pp. 2318-2330
    • Yuabova, Z.Y.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.