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Crystallization of Toxic Glycol Solvates of Rifampin from Glycerin and Propylene Glycol Contaminated with Ethylene Glycol or Diethylene Glycol

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dc.contributor.author Bourne, Susan
dc.contributor.author Caira, Mino
dc.contributor.author Li, Jinjing
dc.contributor.author Liebenberg, Wilna
dc.contributor.author Strydom, Schalk Johannes
dc.contributor.author De Villiers, Melgardt M.
dc.date.accessioned 2012-11-09T09:34:20Z
dc.date.available 2012-11-09T09:34:20Z
dc.date.issued 2011
dc.identifier.citation De Villiers, M. et al. 2011. Crystallization of toxic glycol solvates of rifampin from glycerin and propylene glycol contaminated with ethylene glycol or diethylene glycol. Molecular pharmaceutics, 8(3):877-888. [http://pubs.acs.org/journal/mpohbp/about.htm] en_US
dc.identifier.issn 1543-8384
dc.identifier.issn 1543-8392 (Online)
dc.identifier.uri http://hdl.handle.net/10394/7745
dc.description.abstract This study was initiated when it was suspected that syringe blockage experienced upon administration of a compounded rifampin suspension was caused by the recrystallization of toxic glycol solvates of the drug. Single crystal X-ray structure analysis, powder X-ray diffraction, thermal analysis and gas chromatography were used to identify the ethylene glycol in the solvate crystals recovered from the suspension. Controlled crystallization and solubility studies were used to determine the ease with which toxic glycol solvates crystallized from glycerin and propylene glycol contaminated with either ethylene or diethylene glycol. The single crystal structures of two distinct ethylene glycol solvates of rifampin were solved while thermal analysis, GC analysis and solubility studies confirmed that diethylene glycol solvates of the drug also crystallized. Controlled crystallization studies showed that crystallization of the rifampin solvates from glycerin and propylene glycol depended on the level of contamination and changes in the solubility of the drug in the contaminated solvents. Although the exact source of the ethylene glycol found in the compounded rifampin suspension is not known, the results of this study show how important it is to ensure that the drug and excipients comply with pharmacopeial or FDA standards. en_US
dc.description.uri http://dx.doi.org/10.1021/mp100459y
dc.language.iso en en_US
dc.publisher American Chemical Society en_US
dc.subject Toxic glycols en_US
dc.subject solvate en_US
dc.subject rifampin en_US
dc.subject contaminated solvents en_US
dc.title Crystallization of Toxic Glycol Solvates of Rifampin from Glycerin and Propylene Glycol Contaminated with Ethylene Glycol or Diethylene Glycol en_US
dc.type Article en_US


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