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Title of Journal: Pharm Res

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Abbravation: Pharmaceutical Research

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Springer US

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DOI

10.1007/978-3-319-14923-3_6

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1573-904X

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Nanoparticulate Impurities in PharmaceuticalGrade

Authors: Daniel Weinbuch Jason K Cheung Jurgen Ketelaars Vasco Filipe Andrea Hawe John den Engelsman Wim Jiskoot
Publish Date: 2015/01/30
Volume: 32, Issue: 7, Pages: 2419-2427
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Abstract

In the present study we investigated the rootcause of an interference signal 100–200 nm of sugarcontaining solutions in dynamic light scattering DLS and nanoparticle tracking analysis NTA and its consequences for the analysis of particles in biopharmaceutical drug productsDifferent sugars as well as sucrose of various purity grades suppliers and lots were analyzed by DLS and NTA before and only for sucrose after treatment by ultrafiltration and diafiltration Furthermore Fourier transform infrared FTIR microscopy scanning electron microscopy coupled energydispersive Xray spectroscopy SEMEDX and fluorescence spectroscopy were employedThe intensity of the interference signal differed between sugar types sucrose of various purity grades suppliers and batches of the same supplier The interference signal could be successfully eliminated from a sucrose solution by ultrafiltration 002 μm pore size Nanoparticles apparently composed of dextrans ash components and aromatic colorants that were not completely removed during the sugar refinement process were found responsible for the interference and were successfully purified from sucrose solutions

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