Polysorbates are non-ionic surfactants that are widely used in bio-pharmaceutical formulations as therapeutic agents for various diseases. The quality parameters of PS-80, which prevents aggregation of proteins in formulations, is defined in various monographs such as EP, JP and USP. One such parameter is fatty acid composition.<br/><br/>Although there are established specifications for the fatty acid composition of PS-80 (EP, JP, USP) there is allowance for variation in the types and amounts. For example, there are more than twenty different fatty acids present in PS-80, some that are still not unidentified making the total specified fatty acid composition not equivalent to 100% (typically 94 – 97%). This study is focused on establishing the identity and quantity of the unknown fatty acids in PS-80.<br/><br/>Preliminary results indicated that the unidentified fatty acids contribute between 3-6% to the total fatty acid composition of the samples. Shorter chain fatty acids such as capric acid (&lt;0.05 – 0.78%) and lauric acids (0.167 – 1.84%) contributed small but measurable amounts to the total composition. Longer chain fatty acids like palmitoleic acid (C16:1) and stearic acid (C18:0) contributed negligible amounts. Two of the fatty acids contributing more than 1% to the total fatty acid composition were identified as 10, 13 nonadecadienoic acid (C19:2) and eicosenoic acid (C20:1). Other long chain fatty acids identified were arachiadic (eicosanoic) acid (0.2 – 0.3%) and behenic acid (&lt;0.057 – 0.063%).

Evaluation of the fatty acid composition of polysorbate 80 (PS-80)

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

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