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Published in 2017 at "Pharmaceutical Research"
DOI: 10.1007/s11095-017-2274-4
Abstract: PurposeTo investigate the effect of nanoparticulate impurities (NPIs) isolated from pharmaceutical-grade sucrose, on the stability of monoclonal antibodies (mAbs).MethodsNPIs were purified from pharmaceutical-grade sucrose and spiked into trastuzumab, rituximab, infliximab, and cetuximab formulations. The stability…
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Keywords:
isolated pharmaceutical;
grade sucrose;
nanoparticulate impurities;
pharmaceutical grade ... See more keywords
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Published in 2020 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2020.11.011
Abstract: Sucrose is a commonly used stabilizing excipient in protein formulations. However, recent studies have indicated the presence of nanoparticulate impurities (NPIs) in the size range of 100 - 200 nm in pharmaceutical-grade sucrose. Furthermore, isolated…
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Keywords:
nanoparticulate impurities;
grade sucrose;
vitro;
pharmaceutical grade ... See more keywords