Agilent Cary 630 FTIR Pharmacopoeia compliance

Importance of the Topic

The accurate identification of pharmaceutical ingredients and confirmation of instrument performance are critical for ensuring drug safety and compliance with global regulatory standards. Fourier transform infrared spectroscopy (FTIR) is one of the most widely used techniques for rapid, non-destructive identification of active pharmaceutical ingredients (APIs) and excipients. Harmonization across multiple pharmacopoeias enhances the reliability of quality control processes in the pharmaceutical industry.

Objectives and Study Overview

This application note 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. The study aims to demonstrate that the instrument meets or exceeds standards for wavelength accuracy, spectral resolution, reproducibility and identification of reference materials.

Methodology and Instrumentation

A Cary 630 FTIR system was tested immediately after standard factory validation without additional tuning. Performance tests were implemented using Agilent Microlab PC software with predefined methods for frequency accuracy and resolution measurements. A NIST-traceable 38 µm polystyrene film was analyzed in transmission mode to assess wavelength accuracy and spectral resolution. Identification studies employed both diffuse reflectance (DRIFT) and attenuated total reflectance (ATR) sampling techniques. Sample preparation included KBr pellet formation and ATR/DRIFT accessory measurements.

Main Results and Discussion

All performance metrics fell within or exceeded pharmacopoeial tolerances:

• Wavelength accuracy deviations were two- to tenfold better than the strictest requirements, with maximum deviations under 0.6 cm⁻¹.
• Spectral resolution tests demonstrated clear separation of specified polystyrene peaks, with intensity ratios surpassing minimum transmission thresholds.
• Reproducibility between scans remained below 0.5 %T and wavelength drift under 0.5 cm⁻¹.
• API identification of furosemide and caffeine showed excellent correlation of band positions with reference spectra despite differences in sampling technique and pathlength.

The Cary 630 FTIR’s automated installation and operational qualification software further ensures ongoing instrument performance in regulated environments.

Benefits and Practical Applications

By meeting global pharmacopoeial specifications, the Cary 630 FTIR supports routine quality control workflows in pharmaceutical manufacturing and regulatory testing laboratories. Key advantages include compact footprint, rugged design for field or in-line use, simplified sample handling through ATR and DRIFT accessories, and 21 CFR part 11 compliant data management.

Future Trends and Applications

Continued integration of FTIR with digital laboratory information management systems (LIMS), enhanced chemometric libraries and cloud-based spectral databases will streamline identification workflows. Advances in miniature, portable FTIR instruments may enable on-site raw material verification and counterfeit detection. Development of automated sampling robotics and real-time process monitoring are emerging applications.

Conclusion

The Agilent Cary 630 FTIR spectrometer fully complies with the performance standards of major pharmacopoeias worldwide. Its combination of accuracy, resolution, reproducibility and ease of use makes it an ideal solution for pharmaceutical quality control and regulatory compliance.

Reference

• Higgins F and Seelenbinder J. Agilent Cary 630 FTIR Pharmacopoeia compliance. Agilent Technologies Application Note. Published November 10, 2011; Publication number 5990-9379EN.