Enabling Scalable and Reproducible NMR Analysis for Polymeric Raw Materials in Pharma QC

Enabling Scalable and Reproducible NMR Analysis for Polymeric Raw Materials in Pharma QC

Author(s)

Valentin Poirier

Significance of the Solution

Controlling polymeric excipients, such as cyclodextrins (betadex), poly(lactide-co-glycolide) copolymers (PLGA), poloxamers, and polyethylene glycol (PEG) derivatives, has long presented analytical challenges. Although NMR spectroscopy is a powerful tool for characterizing these materials, its use has traditionally required expert interpretation and manual data processing. The new Advanced Chemical Profiling 2.0 software (ACP 2.0), that integrates with Bruker’s Fourier 80 benchtop NMR, overcomes these barriers by enabling automated, sample-to-report NMR workflows for any quantitative applications. This document demonstrates how ACP 2.0 supports push-button polymer analysis, including for compendial testing, allowing quality control laboratories to obtain accurate, precise, and reproducible results without specialized NMR expertise. It thus provides a robust platform for routine analysis while offering advanced features to address emerging analytical needs.

Key Benefits

• End-to-End automation: ACP 2.0 enables a true sample-to-report workflow: routine users simply submit samples, and all acquisition, processing, and analysis steps are performed automatically in the background. No NMR expertise or manual intervention is required.

• Comprehensive toolbox for simple and complex samples: ACP 2.0 delivers accurate quantification under full automation for any type of sample. It not only streamlines classic workflows but expands the applicability of NMR to a wider range of materials but providing new analysis tools that address challenging samples with signal overlap or baseline distortion.

• Robust, GMP-ready compliance: ACP integrates directly with Bruker GxP readiness platform for comprehensive data integrity, user management, and audit trails - supporting compliance in regulated environments, without additional training for routine users while enhancing analytical workflow robustness.

Download the whitepaper to explore how ACP 2.0 expands the suitability and applicability of NMR in pharmaceutical quality control, offering a robust, unified, and scalable solution for routine testing of simple and complex products.