Screening of Polysorbate-80 Composition by High Resolution Mass Spectrometry with Rapid H/D Exchange-Reference-Cited by-同舟云学术

Screening of Polysorbate-80 Composition by High Resolution Mass Spectrometry with Rapid H/D Exchange

Published:2019-10-22 Issue:22 Volume:91 Page:14649-14656
ISSN:0003-2700
Container-title:Analytical Chemistry
language:en
Short-container-title:Anal. Chem.

Author:

Yang Kui¹^ORCID,Hewarathna Asha¹,Geerlof-Vidavsky Ilan¹,Rao V. Ashutosh²,Gryniewicz-Ruzicka Connie¹,Keire David¹

Affiliation:

1. Division of Pharmaceutical Analysis, Office of Testing and Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, St. Louis, Missouri 63110, United States

2. Division of Biotechnology Review and Research III, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20903, United States

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.analchem.9b03809

Reference34 articles.

1. Polysorbates 20 and 80 Degradation by Group XV Lysosomal Phospholipase A 2 Isomer X1 in Monoclonal Antibody Formulations

2. Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations

3. Toward Understanding Molecular Heterogeneity of Polysorbates by Application of Liquid Chromatography–Mass Spectrometry with Computer-Aided Data Analysis

4. Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways

5. Use of High Resolution Mass Spectrometry for Analysis of Polymeric Excipients in Drug Delivery Formulations

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