Agilent Cary 630 FTIR

Significance of the Topic

The ability to perform rapid, reliable and regulation-compliant chemical analysis is critical in pharmaceutical quality control, quality assurance, and method development. FT-IR spectroscopy provides non-destructive identification and quantification of active ingredients, excipients, and packaging materials, ensuring product safety, authenticity, and compliance with international pharmacopeia standards.

Objectives and Study Overview

This whitepaper presents the capabilities of the Agilent Cary 630 FT-IR spectrometer and its MicroLab software for routine laboratory and manufacturing applications. It aims to demonstrate how simple spectral matching, multivariate classification, and quantitative models can address daily analytical challenges such as raw material identification, in-process monitoring, final product verification, and counterfeit detection.

Used Methodology and Instrumentation

The analytical strategy combines the following approaches:

• Qualitative identification via single-spectrum library search
• Classification of closely related compounds using PLS-DA chemometrics
• Quantitative determination of APIs and excipients using Beer’s law or multivariate PLS calibration

The instrumentation includes:

• Agilent Cary 630 FT-IR spectrometer with pre-aligned sampling interfaces
• MicroLab software (21 CFR Part 11 compliant) featuring guided workflows and automated IQ/OQ
• Sampling accessories: ATR, diffuse reflectance, transmission, DialPath liquid cell, TumblIR liquid accessory

Main Findings and Discussion

The Cary 630 delivers:

• High wavelength accuracy and spectral resolution compliant with USP, EP, JP, CP, IP and other pharmacopeia requirements
• Automatic accessory recognition for fast, alignment-free sample measurement
• Minimal footprint (20 cm × 20 cm) suitable for labs, gloveboxes, and fume hoods
• Robust 21 CFR Part 11 features including audit trail, user management, and data security

Application results show reliable identification of unknown pharmaceutical ingredients and packaging polymers, accurate quantification of formulation components, and rapid screening for counterfeit or adulterated products.

Benefits and Practical Applications

The Cary 630 FT-IR system enables:

• Qualification of incoming raw materials and in-process checks to prevent out-of-specification or mislabeled inputs
• Verification of final product purity and authenticity before shipment
• Screening of packaging polymers at all production stages to ensure material compliance with USP 661.1
• Counterfeit drug detection by spectral comparison with certified standards
• Quantification of specific components in solids and liquids without extensive sample preparation

Future Trends and Applications

Emerging developments may include:

• Integration of real-time data streaming and cloud-based analytics for remote monitoring
• Advanced chemometric and machine-learning models for predictive quality control
• Miniaturized, portable FT-IR modules for on-line process analysis
• Combined spectroscopic approaches (NIR, Raman) for multi-modal characterization

Conclusion

The Agilent Cary 630 FT-IR combined with MicroLab software offers a compact, compliant, and user-friendly solution for pharmaceutical laboratories and manufacturing sites. Its rapid identification, classification, and quantification capabilities support regulatory requirements, enhance workflow efficiency, and improve product safety.