Agilent Raman Solutions for Pharmaceutical QC

Significance of Topic

Pharmaceutical quality control demands rapid, non-destructive analysis for raw material identification, content uniformity testing and polymorph characterization. Raman spectroscopy, enhanced by spatially offset and transmission modalities, meets these needs by enabling container-through measurements, minimal sample preparation and high throughput, aligning with evolving regulatory requirements.

Study Objectives and Overview

This article reviews Agilent’s Raman solutions—Vaya, RapID and TRS100—designed to:

• Authenticate raw materials without opening containers
• Perform content uniformity (CU), assay and solid-state analysis in oral solid dosage forms
• Reduce operational costs and accelerate QC workflows

Methodology and Instrumentation

• Vaya handheld Raman with SORS: Delivers material ID in seconds through clear vials, colored liners, plastic tubs, FIBCs, paper sacks and amber glass without sampling.
• RapID portable SORS system: Handles challenging opaque containers (excluding metal/fiber drums), integrates barcode scanning and networking, and supports GMP and 21 CFR Part 11 compliance.
• TRS100 transmission Raman: Quantitatively analyzes intact tablets, capsules and powders for CU, assay, ID and polymorph content in under 10 seconds per sample array, eliminating solvents, consumables and extensive prep.

Key Results and Discussion

The TRS100 system achieved:

• CU and assay on up to 300 tablets per tray in 10–15 minutes versus hours for HPLC workflows.
• Quantification of active pharmaceutical ingredients and polymorphic forms down to 0.1–1 % w/w with high specificity.
• Per-campaign cost savings of thousands of dollars and removal of solvents, columns and UV lamps.

Practical Benefits and Applications

• Direct ID testing in quarantine areas speeds material release to manufacturing.
• Simplified, 100 % ID workflows that comply with GMP and 21 CFR Part 11.
• Nondestructive stability studies, formulation development support and at-line or real-time release testing.

Future Trends and Opportunities

• Integration of Raman analytics into automated warehouses and digital QA/QC platforms.
• Expansion of transmission Raman for continuous manufacturing and inline process monitoring.
• Advances in chemometric algorithms and machine learning for enhanced polymorph screening and predictive quality control.

Conclusion

Agilent’s Vaya, RapID and TRS100 systems harness SORS and transmission Raman spectroscopy to revolutionize pharmaceutical QC by offering fast, container-through material ID, content uniformity and polymorph analysis. These solutions drive cost savings, boost throughput and ensure regulatory compliance, supporting more agile and data-driven manufacturing.