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New Mixed-Mode LC Column Enables Polysorbate 80 Stability Monitoring in Protein Formulations (AN-1193)
Polysorbate 80 (commonly known as Tween-80) is a non-ionic surfactant comprising a heterogeneous mixture of partial fatty acid esters. It is widely used as a stabilizing agent in biopharmaceutical formulations. However, polysorbate 80 is susceptible to degradation via oxidation and enzymatic hydrolysis, which can alter the profile of its sub-components. Monitoring these changes is essential for evaluating the quality and stability of drug formulations. Webster et al. proposed a balanced method that separates polysorbate 80 into distinct peaks using a column packed with Strata Poly X-A material. This approach offers a moderate run time and yields a late-eluting peak that is free from interference by protein formulation components—making it suitable as a stability-indicating method. In this application note, we implemented Webster’s method using the commercially available Biozen Poly X-A column.
New Mixed-Mode LC Column Enables Polysorbate 80 Stability Monitoring in Protein Formulations (AN-1193)
Polysorbate 80 (commonly known as Tween-80) is a non-ionic surfactant comprising a heterogeneous mixture of partial fatty acid esters. It is widely used as a stabilizing agent in biopharmaceutical formulations. However, polysorbate 80 is susceptible to degradation via oxidation and enzymatic hydrolysis, which can alter the profile of its sub-components. Monitoring these changes is essential for evaluating the quality and stability of drug formulations. Webster et al. proposed a balanced method that separates polysorbate 80 into distinct peaks using a column packed with Strata Poly X-A material. This approach offers a moderate run time and yields a late-eluting peak that is free from interference by protein formulation components—making it suitable as a stability-indicating method. In this application note, we implemented Webster’s method using the commercially available Biozen Poly X-A column.
Document Type:
Technical Notes
Target Industries:
Techniques:
Brands:
Separation Modes:
Reversed Phase
New Mixed-Mode LC Column Enables Polysorbate 80 Stability Monitoring in Protein Formulations (AN-1193)
Polysorbate 80 (commonly known as Tween-80) is a non-ionic surfactant comprising a heterogeneous mixture of partial fatty acid esters. It is widely used as a stabilizing agent in biopharmaceutical formulations. However, polysorbate 80 is susceptible to degradation via oxidation and enzymatic hydrolysis, which can alter the profile of its sub-components. Monitoring these changes is essential for evaluating the quality and stability of drug formulations. Webster et al. proposed a balanced method that separates polysorbate 80 into distinct peaks using a column packed with Strata Poly X-A material. This approach offers a moderate run time and yields a late-eluting peak that is free from interference by protein formulation components—making it suitable as a stability-indicating method. In this application note, we implemented Webster’s method using the commercially available Biozen Poly X-A column.
| Target Industries: | Biopharmaceutical Analysis |
| Techniques: | HPLC, HPLC Reversed Phase |
| Brands: | Biozen LC |
| Separation Modes: | Reversed Phase |
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Phenomenex is a technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers worldwide.