Identification of leachables observed in the size exclusion chromatograms of a low concentration product stored in prefilled syringes-Reference-Cited by-同舟云学术

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Identification of leachables observed in the size exclusion chromatograms of a low concentration product stored in prefilled syringes

Published:2017-05 Issue: Volume:139 Page:133-142
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Valente Joseph J.,Peddicord Michael B.,Rinaldi Frank A.,Kelly Kathleen A.,Bolgar Mark S.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference50 articles.

1. Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective;Markovic;Expert Opin. Drug Saf.,2007

2. Effects of surfaces and leachables on the stability of biopharmaceuticals;Bee;J. Pharm. Sci.,2011

3. Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables;Jenke;J. Pharm. Sci.,2007

4. Impact of residual impurities and contaminants on protein stability;Wang;J. Pharm. Sci.,2014

5. Leachables from saline-containing IV bags can alter therapeutic protein properties;Chang;Pharm. Res.,2010

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