Pharmaceutical Quality Control via FT-IR

Significance of the topic

FT-IR spectroscopy plays a critical role in pharmaceutical quality control by enabling identification and quantification of APIs, excipients, and contaminants under GMP/GLP compliance. Its molecular fingerprinting capability ensures product integrity and regulatory adherence.

Study objectives and overview

This application note demonstrates the use of Bruker FT-IR instrumentation and OPUS software for pharmaceutical QC tasks including raw material verification, contaminant analysis, polymorphism studies, and quantitative measurements.

Methodology and Instrumentation

• Fourier-Transform-Infrared (FT-IR) spectroscopy for molecular fingerprinting.
• ATR (attenuated total reflectance) for rapid identity checks without sample preparation.
• FT-IR microscopy for mapping and identifying micro-contaminants in formulations.
• Bruker OPUS software offering GLP/GMP/21 CFR Part 11 compliance, audit trails, and secure data management.
• OPUS Validation Program (OVP) and Internal Validation Unit (IVU) for automated instrument qualification (OQ, PQ) and continuous performance monitoring.

Main results and discussion

FT-IR spectra of acetylsalicylic acid, talc, mannitol, and glycerol illustrate distinct absorption patterns serving as chemical fingerprints. ATR analysis yields identity confirmation within seconds. Microscopic mapping reveals distribution of APIs, excipients, and polymorphs in tablets and lyophilized samples. OPUS software successfully automates material identification against extensive reference libraries while ensuring data integrity and traceability.

Benefits and practical applications

• Rapid, non-destructive verification of raw materials and finished dosage forms.
• Detection and characterization of particulate contaminants.
• Polymorphism assessment for critical quality attributes.
• Quantitative analysis of powders, granules, tablets, creams, and liquids.
• Comprehensive compliance with regulatory standards and audit requirements.

Future trends and applications

• Integration of machine learning algorithms for enhanced spectral interpretation and predictive maintenance.
• Development of benchtop and portable FT-IR devices for inline and at-line monitoring in manufacturing.
• Hyphenation with chromatographic and mass spectrometric techniques for deeper molecular insights.
• Advanced software platforms enabling cloud-based data management and real-time collaboration.

Conclusion

Bruker FT-IR systems combined with robust OPUS software deliver a powerful solution for pharmaceutical quality control, offering rapid identification, quantification, and traceable data management within a fully compliant framework.

Reference

Application note: Pharmaceutical Quality Control via FT-IR, Bruker Optics, 2021.