SPECTROSCOPY SOLUTIONS FOR PHARMACEUTICALS

Significance of the Topic

Atomic and molecular spectroscopy play a critical role in the pharmaceutical industry, addressing stringent regulatory requirements, ensuring product quality, and enabling efficient drug development workflows.

Study Objectives and Overview

This whitepaper reviews Agilent’s range of spectroscopy platforms designed for pharmaceutical laboratories, highlighting new technologies and their capabilities in routine and critical assessments.

Methodology and Used Instrumentation

The analysis covers Agilent’s latest instrumentation:

• Agilent 7900 ICP-MS: Ultra-high matrix tolerance, wide dynamic range, helium collision mode, USP 232/233 compliance.
• Agilent 5110 SVDV ICP-OES: Simultaneous axial and radial detection, DSC optics, solid-state RF, low argon consumption.
• Agilent 200 Series AAS: Flame and Zeeman graphite furnace options, hydride vapor generation accessory.
• Agilent Cary 8454 UV-Vis: Photodiode array detection, rapid full-spectrum acquisition, GLP and pharmacopoeia compliance.
• Agilent Cary 630 FTIR: Compact benchtop, interchangeable sampling (ATR, transmission, DialPath), FDA 21 CFR Part 11 support.
• Agilent Cary Eclipse Fluorescence: Xenon flash lamp, high sensitivity, kinetic measurements, microplate compatibility.

Main Results and Discussion

Each platform demonstrates significant performance improvements:

• The 7900 ICP-MS achieves tenfold improvements in matrix tolerance, dynamic range, and signal-to-noise, reducing reruns and ensuring accurate trace metal quantification.
• The 5110 SVDV ICP-OES’s dual-view capability doubles throughput by measuring major to trace elements in a single run.
• AAS systems offer cost-effective solutions for targeted metal analysis, with furnace designs delivering ppb-level sensitivity.
• UV-Vis and FTIR instruments provide rapid, reproducible spectral data, supporting both qualitative and quantitative assays under regulatory frameworks.
• Fluorescence detection extends analytical flexibility with multiple collection modes and high-speed scanning for kinetic studies.

Benefits and Practical Applications

Agilent’s spectroscopy solutions deliver:

• Enhanced throughput and reduced cost per analysis.
• Regulatory compliance with USP, FDA, GLP, and GMP standards.
• Versatile sampling and software integration for end-to-end workflows.
• Robust data quality with advanced interference removal and precision optics.

Future Trends and Potential Applications

Emerging directions include greater automation, integration with laboratory information management systems, miniaturized detectors for process analytical technology (PAT), and AI-driven data analysis to further streamline drug development and quality control.

Conclusion

Agilent’s comprehensive suite of atomic and molecular spectroscopy instruments offers pharmaceutical laboratories the accuracy, flexibility, and regulatory compliance needed to meet evolving industry demands and drive future innovations.