volume 267, issue 1-2, P113-120 2003
DOI: 10.1016/j.ijpharm.2003.08.004
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Abstract: During a compatibility study between a formulation containing sulfobutylether cyclodextrin (SBECD) and silicone tubing, an extraneous peak was observed in the HPLC chromatograms. The extraneous material was identified by LC/MS, MS/MS and UV as a previously unreported tubing extractable, o-phenylphenol (o-PP). Several studies were conducted to assess the impact of formulation and process-related variables on the amount of the o-PP extracted, including contact time, sulfobutylether cyclodextrin concentration, fo…

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