Excipients in Biopharma – Polysorbate Analysis

Polysorbates are non-ionic surfactants widely used in pharmaceutical, food, and cosmetic products to solubilize ingredients, stabilize emulsions and enhance formulation stability and texture. The complex heterogeneous nature and lack of strong chromophore present challenges for the analysis and quality control of Polysorbate 80. The U.S. Pharmacopeia (USP) procedure relies on a complex reflux procedure and GC-FID analysis.

In this webinar, we present a high-throughput HPLC method using Charged Aerosol Detection for the quantification of fatty acids in polysorbate 80.

Method performance characteristics including quantification limits, linearity, system suitability are demonstrated. The developed method enables reliable quality testing by measuring fatty acid composition in polysorbate 80 raw materials.

Key Takeaways

• Discover a new CAD solution designed for reliable analysis of non-UV detectable compounds, including PS20 and PS80.
• Learn how a single-vendor platform can support robust, compliance-ready analytical workflows.
• Explore advanced CDS enhancements, orthogonal detection strategies, and integrated machine learning capabilities that simplify data analysis and improve productivity.

This webinar is designed for:

Biopharma professionals involved in protein therapeutics, analytical development, and quality control of raw materials and formulations.

Don't miss it!

Presenter: Margaret Maziarz (Principal Scientist, Waters Corporation)

In her current role, she is responsible for development, validation, modernization, scaling, and transfer of analytical methods. She specializes in development of new applications, creating technical seminar presentations, webinars, marketing collateral and demo projects to support the sales and marketing organizations globally.

Before joining Waters in 2010, Margaret held various scientific positions in life sciences industry.

Presenter: Pawel Bigos (Senior Scientist, Waters Corporation)

Pawel Bigos is a Senior Scientist at Waters Corporation in the QA/QC Biologics group in Milford, Massachusetts. He holds a Bachelor of Science degree in Chemistry from the University of South Florida.

Prior to Waters, Pawel gained valuable experience at Frequency Therapeutics, Novartis, and Symbiotic Research. Since joining Waters in 2022, he has concentrated on biomolecule separations and plays a critical role in providing analytical support in the development, commercialization, and application of Waters innovative products.