Monitoring Impurities Using a High Throughput Focused Gradient With the Alliance™ iS Bio System

The Alliance iS Bio HPLC System provides an efficient HPLC platform for routine monitoring of quality indicating attributes in protein drug substances. Innovative products such as Waters IonHance™ difluoroacetic acid, when used in conjunction with the Titanium diffusion bonded mixer, and the integrated sample metering pump, provides improved UV-detection through reduced baseline noise, increased sensitivity, and reliable detection for improved peak integration. This unique configuration increases confidence in monitoring low-abundant impurities by retention time matching in UV-based assays, making it particularly well-suited for quality control environments. In this study, a shortened focused gradient targeting an oxidized peptide and its native species was developed via mass confirmation and transferred to the Alliance iS Bio HPLC System which provides high throughput and efficient monitoring.

Benefits
- The Titanium diffusion bonded mixer reduces baseline noise for increased confidence in detecting low-abundant impurities via retention time matching
- The sample metering pump and large volume needle loop of the Alliance iS Bio HPLC System is capable of precise injections up to 100 µL, bypassing the need for external loops
- The Alliance iS Bio HPLC System consistently monitors low-abundant impurities over extended analysis periods