AI Article Synopsis

  • Non-ionic surfactants like polysorbate 20, polysorbate 80, and poloxamer188 are commonly used in parenteral protein formulations, and their quantification is important due to their role in visible particle formation.
  • A new mixed mode chromatography method with single quad mass detection has been developed to effectively quantify surfactants and their degradation patterns in highly concentrated protein formulations.
  • This method demonstrated strong performance characteristics, including high linearity, precision, and accuracy, meeting current pharmaceutical standards as outlined in ICH Q2.

Article Abstract

Non-ionic surfactants are commonly used in parenteral protein formulations and include polysorbate 20, polysorbate 80 and poloxamer188. Recently, quantification and characterization of surfactants has generated considerable interest due to their connection to visible particle formation, a critical quality attribute for parenteral formulations. Typically, surfactant quantification is performed by mixed mode chromatography with evaporative light scattering detection (ELSD) or charged aerosol detection (CAD). However, these methods often suffer from loss of specificity in highly concentrated protein formulations. Here we present a mixed mode chromatography method using single quad mass detection, overcoming current limitations for highly concentrated proteins. In addition to content determination of intact surfactants, this method allows to quantify and characterize the predominant degradation patterns of polysorbates within a single measurement. Formulations with up to 200 mg/mL active pharmaceutical product (API) containing surfactant levels between 0.16 and 0.64 mg/mL were tested during method qualification. The obtained results for linearity (r > 0.99), precision (max. 3.8 % RSD) and accuracy (96-116 % recovery) meet current requirements for pharmaceutical products as defined in ICH Q2.

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http://dx.doi.org/10.1016/j.jpba.2023.115651DOI Listing

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