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FDA raised concerns about impurities, aggregates, endotoxins and immunogenicity

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J R Stat Soc Series B Stat Methodol 57:289300 Bentayeb K, Batlle R, Sanchez C, Nerin C, Domeno C (2008) Determination of bile acids in human serum by on-line restricted access material-ultra high-performance liquid chromatography-mass spectrometry

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