Using SEC-MALS-IV to Characterize PLGA for FDA Generic Drug Approval

Chris Deng

Presented By: Chris Deng, Ph.D., Wyatt Technology
Presented Live: November 14, 2019

Traditionally, size exclusion chromatography (SEC) with column calibration is used to obtain the molar mass distributions of polymers such as PLGA. However, this technique has significant drawbacks as it assumes the standards used for calibration are physically similar to the sample, of particular concern for copolymers and other non-standard macromolecules. In comparison, multi-angle light scattering utilizes first principles to obtain a truly accurate molar mass measurement. Combined with a differential viscometer to measure intrinsic viscosity (IV), SEC-MALS produces a bevy of useful information from PLGA analysis, including branching ratio and conformation.

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