Agilent Cary 630 FTIR Pharmacopoeia compliance

Significance of the Topic

The identification and quality control of pharmaceutical substances are critical to ensure patient safety and regulatory compliance. Fourier transform infrared (FTIR) spectroscopy is widely used for rapid, non-destructive analysis and meets standardized criteria in multiple pharmacopoeial compendia.

Objectives and Study Overview

This study evaluates the compliance of the Agilent Cary 630 FTIR spectrometer against performance requirements specified in the United States, European, Japanese, Chinese, Indian and International Pharmacopoeias. Tests focus on resolution, frequency accuracy, reproducibility and identification of model compounds.

Methodology and Workflow

A dedicated Microlab PC method was configured to collect spectra at 4 cm⁻¹ resolution using triangular apodization, no zero filling and a 30 s acquisition (74 co-added scans). A 38 µm NIST-traceable polystyrene film was measured in transmission mode for resolution and accuracy tests. Identification studies used reference spectra of furosemide and caffeine from the International Pharmacopoeia, acquired via DRIFT or ATR techniques.

Instrumentation Used

• Agilent Cary 630 FTIR spectrometer with interchangeable transmission, DRIFT and ATR sampling modules
• Microlab PC software, compliant with 21 CFR Part 11 for data integrity and audit trails
• Automated IQ/OQ qualification software for routine performance verification

Main Results and Discussion

The Cary 630 FTIR exceeded pharmacopoeial specifications: frequency accuracy was 2–10× tighter than limits; resolution tests passed all criteria with margins (e.g. >0.43 AU and >25 %T vs. required >0.33 AU and >18 %T); reproducibility Δ%T and Δcm⁻¹ were well below thresholds. Spectral identification of furosemide and caffeine showed excellent agreement in band positions, confirming reliable compound verification regardless of sampling mode.

Benefits and Practical Applications

The combined features of compact footprint, rugged design and user-friendly, regulation-compliant software make the Cary 630 FTIR ideal for high-throughput pharmaceutical quality control. Automated qualification routines reduce downtime, and multiple sampling options simplify routine identification workflows.

Future Trends and Opportunities

Ongoing developments may include integration of real-time process analytical technology (PAT), advanced chemometric and machine learning algorithms for spectral interpretation, and expanded online connectivity for remote monitoring and data management in GMP environments.

Conclusion

The Agilent Cary 630 FTIR fully meets or surpasses the performance specifications of major global pharmacopoeias. Its robust hardware, comprehensive software suite and versatile sampling capabilities support accurate, efficient pharmaceutical identification and quality control.

References

1. Higgins F., Seelenbinder J. Agilent Cary 630 FTIR Pharmacopoeia Compliance. Agilent Technologies Application Note, November 2011, Publication No. 5990-9379EN.
2. Pharmaceutical Technology Europe. FTIR Identification. September 2011, pp. 87–88.