Simultaneous quantification of polysorbate 20 and poloxamer 188 in biopharmaceutical formulations using evaporative light scattering detection.

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第一作者： Christoph A,Paschen

第一单位： F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070, Basel, Switzerland.

作者： Christoph A,Paschen ^[1] ; Denis,Klemm ^[1] ; Tobias,Graf ^[2] ; Robert,Kopf ^[1] ; Cosimo,Pinto ^[1] ; Claudia,Müller ^[1] ; Christian H,Bell ^[1] ; Janina,Pfaff ^[3]

作者单位： F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070, Basel, Switzerland. ^[1] Roche Diagnostics GmbH, Nonnenwald 2, 82377, Penzberg, Germany. ^[2] F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070, Basel, Switzerland. Electronic address: janina.pfaff@roche.com. ^[3]

关键词 DoE HPLC-ELSD MAb formulation Mixed-mode chromatography Poloxamer 188 Polysorbate 20 Surfactants

主题词生物制品(Biological Products);色谱法, 高压液相(Chromatography, High Pressure Liquid);泊洛沙姆(Poloxamer);聚山梨醇酯类(Polysorbates);散射, 辐射(Scattering, Radiation);表面活性剂(Surface-Active Agents)

DOI 10.1016/j.jpba.2020.113640

PMID 33002754

发布时间 2021-06-17

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