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Volumn 14, Issue 4, 2010, Pages 1021-1026

Removal of electrophilic potential genotoxic impurities using nucleophilic reactive resins

Author keywords

[No Author keywords available]

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENTS; BENZENESULFONIC ACID; DOWNSTREAM-PROCESSING; GENOTOXIC IMPURITIES; HIGH YIELD; IDEAL SOLUTIONS; MATRIX EFFECTS; METHANE SULFONIC ACID; NUCLEOPHILIC RESINS; PREPARATIVE CHROMATOGRAPHY; PROCESS DEVELOPMENT; REACTIVE RESIN; RECRYSTALLIZATIONS; RESIN LOADING; SOLVENT CONSUMPTION; SOLVENT EFFECTS; TOXIC IMPURITIES;

EID: 77955355500     PISSN: 10836160     EISSN: 1520586X     Source Type: Journal    
DOI: 10.1021/op1000397     Document Type: Article
Times cited : (41)

References (30)
  • 1
    • 55849151593 scopus 로고    scopus 로고
    • CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006; Committee for Medicinal Products (CHMP), European Medicines Agency (EMEA): London, UK, 28 June
    • Guideline on the Limits of Genotoxic Impurities, CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006; Committee for Medicinal Products (CHMP), European Medicines Agency (EMEA): London, UK, 28 June 2006
    • (2006) Guideline on the Limits of Genotoxic Impurities
  • 3
    • 76749103090 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Silver Spring, MD, U.S.A., December
    • Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Silver Spring, MD, U.S.A., December 2008; http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm079235.pdf
    • (2008) Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches
  • 11
    • 77955365169 scopus 로고    scopus 로고
    • See.
    • See: http://www.restek.com/aoi-pharm-A024.asp.
  • 15
    • 77955361247 scopus 로고
    • U.S. Dept. of Labor, Occupational Safety and Health Administration: OSHA Salt Lake Technical Center, Salt Lake City, UT,; Vol., Publ. #4542; American Conference of Governmental Industrial Hygienists (ACGIH), Cincinnati, OH.
    • OSHA Analytical Methods Manual; U.S. Dept. of Labor, Occupational Safety and Health Administration: OSHA Salt Lake Technical Center, Salt Lake City, UT, 1990; Vol. 1, Publ. #4542; American Conference of Governmental Industrial Hygienists (ACGIH), Cincinnati, OH.
    • (1990) OSHA Analytical Methods Manual , vol.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.