![]() and the American Pharmacists Association. The techniques and observations described will be useful for the correct identification of proteinaceous versus nonproteinaceous particles in pharmaceutical products. In addition, particles containing a mixture of protein and fatty acids were also identified, suggesting that the particulation pathways for the two particle types may not be distinct. The particles were readily distinguishable from protein particles by these methods. They could be identified by distinct IR bands, with additional confirmation from energy-dispersive X-ray spectroscopy analysis. The fatty acid particles were granular or sand-like in morphology and were several microns in size. These fatty acid particles were observed in multiple mAb formulations during their expected shelf life under recommended storage conditions. We report, for the first time, the identification of fatty acid particles in formulations containing the surfactant polysorbate 20. Free fatty acid particles in protein formulations, part 1: microspectroscopic identification.Ĭao, Xiaolin Fesinmeyer, R Matthew Pierini, Christopher J Siska, Christine C Litowski, Jennifer R Brych, Stephen Wen, Zai-Qing Kleemann, Gerd R ![]()
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