Unified Multi Attribute Testing of Organic Excipients in Biologic Formulations

Controlling organic excipients is essential in biologic drug development and quality control, yet conventional chromatographic methods often require multiple assays, extensive preparation, and systematic calibration efforts. This whitepaper introduces a unified benchtop NMR workflow that significantly simplifies testing through direct and fully automated multi attribute procedures.

Using the Fourier 80 benchtop NMR in combination with the new Advanced Chemical Profiling software, the automated method delivers accurate quantitation of organic excipients such as sugars, amino acids, antioxidants, and surfactants with a single-point calibration and without necessitating any sample preparation.

Highlights

• Push-button automated workflows for multiple excipients
• Direct analysis of neat formulations
• Single point external calibration
• Robust quantitation across concentration ranges and instruments
• Suitable for development, stability studies, and routine QC in regulated environments

Download the Whitepaper

Learn how automated benchtop NMR streamlines excipient testing in biologics through unified multi attribute workflows.