Agilent TRS100 Raman

Importance of the Topic

The Agilent TRS100 Raman system addresses the growing need for rapid, non-destructive quality control in pharmaceutical manufacturing. By enabling direct measurement of intact tablets and capsules, it streamlines content uniformity, assay, and identification tests, reducing reliance on time-consuming wet-chemistry methods.

Objectives and Study Overview

This document presents the capabilities and advantages of the TRS100 in routine QC and formulation development. It highlights throughput, simplicity of method development, regulatory compliance, and cost savings compared to traditional techniques.

Methodology and Instrumentation

Transmission Raman Spectroscopy (TRS) employs an 830 nm laser to collect spectra through entire dosage forms. Key features include:

• Intact sample analysis without preparation
• High chemical specificity for APIs, excipients, and polymorphs
• Automated sample trays holding up to 300 units
• Integrated software with chemometric engine
• Regulatory-approved calibration using NIST/ASTM standards

Key Results and Discussion

Comparative data show the TRS100 method can complete content uniformity and assay for an eight-batch campaign in approximately 120 minutes, versus 1,700 minutes for HPLC, eliminating solvents and consumables. Spectra demonstrate sharp, easily interpreted features with low limits of quantification (0.1–1% w/w). Polymorph detection in intact tablets reaches LOQ below 1% in seconds, outperforming pXRD and ssNMR in speed and simplicity.

Benefits and Practical Applications

The TRS100 offers:

• High throughput real-time release testing and in-process monitoring
• Lean calibration via design of experiments
• Regulatory compliance for USP, EP, and 21 CFR Part 11
• Versatility for tablets, capsules, powders, gels, and microplates
• Cost reduction by removing solvents, consumables, and skilled labor time

Future Trends and Opportunities

Transmission Raman is poised to expand adoption through:

• Integration with continuous manufacturing and PAT frameworks
• Enhanced sensitivity via beam guiding or multiplexing
• Broader application in low-dose and multi-API formulations
• Advanced chemometric models for real-time decision support

Conclusion

The Agilent TRS100 Raman system transforms pharmaceutical QC by offering a fast, non-destructive, and fully compliant alternative to traditional analytical methods. Its ability to assay, verify, and quantify APIs, polymorphs, and excipients in intact dosage forms significantly accelerates workflows and lowers operational costs.

References

1. Kumar et al., American Pharmaceutical Review, 19(1), February 2016.
2. Ph. Eur. Chapter 2.9.47, Demonstration of Uniformity of Dosage Units Using Large Sample Sizes.
3. ICH Q2(R1), Q8, Q9, Q10 guidelines.
4. FDA and EMA guidance on near-infrared analytical procedures and spectroscopy in pharmaceuticals.