Using SEC-MALS-IV to Characterize PLGA for 

FDA Generic Drug Approval 

•  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. 

Using SEC-MALS-IV to Characterize PLGA for FDA Generic Drug Approval from Wyatt Technology on Vimeo.