Risk assessment report of potential impurities in cetirizine dihydrochloride.

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第一作者： Adrian,Leistner

第一单位： University of Würzburg, Institute for Pharmacy and Food Chemistry, 97074, Würzburg, Germany.

作者： Adrian,Leistner ^[1] ; Stephan,Haerling ^[2] ; Joerg-Detlef,Kreher ^[2] ; Ivonne,Becker ^[2] ; Dirk,Jung ^[2] ; Ulrike,Holzgrabe ^[3]

作者单位： University of Würzburg, Institute for Pharmacy and Food Chemistry, 97074, Würzburg, Germany. ^[1] Arevipharma GmbH, Quality Unit, 01445, Radebeul, Germany. ^[2] University of Würzburg, Institute for Pharmacy and Food Chemistry, 97074, Würzburg, Germany. Electronic address: ulrike.holzgrabe@uni-wuerzburg.de. ^[3]

关键词 Active pharmaceutical ingredients Cetirizine dihydrochloride Manufacturing process Related substances Risk assessment Unexpected impurities

主题词西替利嗪(Cetirizine);药物污染(Drug Contamination);药用制剂(Pharmaceutical Preparations);危险性评估(Risk Assessment);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1016/j.jpba.2020.113425

PMID 32599488

发布时间 2021-06-17

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