Degradation of polysorbates 20 and 80 catalysed by histidine chloride buffer.

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作者： Ema Valentina,Brovč ^[1] ; Janez,Mravljak ^[2] ; Roman,Šink ^[3] ; Stane,Pajk ^[4]

作者单位： University of Ljubljana, Faculty of Pharmacy, The Chair of Pharmaceutical Chemistry, Aškerčeva 7, SI-1000 Ljubljana, Slovenia; Global Drug Development, Technical Research & Development, Novartis, Biologics Technical Development Mengeš, Drug Product Development Biosimilars, Lek Pharmaceuticals d.d., Kolodvorska 27, SI-1234 Mengeš, Slovenia. ^[1] University of Ljubljana, Faculty of Pharmacy, The Chair of Pharmaceutical Chemistry, Aškerčeva 7, SI-1000 Ljubljana, Slovenia. ^[2] Global Drug Development, Technical Research & Development, Novartis, Biologics Technical Development Mengeš, Drug Product Development Biosimilars, Lek Pharmaceuticals d.d., Kolodvorska 27, SI-1234 Mengeš, Slovenia. Electronic address: roman.sink@novartis.com. ^[3] University of Ljubljana, Faculty of Pharmacy, The Chair of Pharmaceutical Chemistry, Aškerčeva 7, SI-1000 Ljubljana, Slovenia. Electronic address: stane.pajk@ffa.uni-lj.si. ^[4]

关键词 Biopharmaceutical formulations Degradation Histidine buffer Liquid chromatography Mass spectrometry Polysorbates

主题词缓冲剂(Buffers);催化作用(Catalysis);氯化物(Chlorides);组氨酸(Histidine);聚山梨醇酯类(Polysorbates)

DOI 10.1016/j.ejpb.2020.07.010

PMID 32693155

发布时间 2021-06-02

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