USP General Chapter <857> and Ph. Eur. Chapter 2.2.25 10th Edition

Importance of the Topic

Compliance with pharmacopeial standards for UV-Vis spectrophotometry is essential in pharmaceutical quality control. The updates to USP General Chapter <857> and Ph. Eur. Chapter 2.2.25 introduce stricter performance criteria for wavelength accuracy, photometric performance, stray light, and resolution, driving the need for robust instrument qualification procedures.

Objectives and Study Overview

This whitepaper examines how the Agilent Cary 60 and Cary 3500 UV-Vis spectrophotometers fulfill the revised USP and Ph. Eur. requirements. It outlines the qualification tests, reference materials, software support, and compliance services available to ensure pharmaceutical laboratories meet regulatory deadlines.

Methodology and Equipment

Qualification covers four key performance areas using specified test procedures and reference standards:

• Wavelength Accuracy and Reproducibility: tested with holmium oxide in perchloric acid, didymium, and cerium sulfate.
• Photometric Accuracy and Linearity: assessed using potassium dichromate, NIST glass filters, and nicotinic acid across the full absorbance range.
• Stray Light Evaluation: Procedures A (ratio method) and B (max absorbance/min transmittance) employ potassium chloride, acetone, sodium iodide, and sodium nitrate.
• Resolution Control: measured using a toluene/hexane mixture.

Both Cary models support the full sequence of tests over the intended operating range with updated test limits and reference materials.

Used Instrumentation

• Agilent Cary 60 and Cary 3500 UV-Vis spectrophotometers.
• Unique Xenon flash lamp with over 10 years of operational life, eliminating warm-up time.
• Optional software packages for 21 CFR Part 11 and EU Annex 11 compliance, supporting electronic records and signatures.
• Manufactured under an ISO 9001 certified quality management system.

Key Results and Discussion

Both the Cary 60 and Cary 3500 demonstrated compliance with the updated pharmacopeial criteria for wavelength accuracy, photometric performance, stray light, and resolution. The long-lived xenon lamp and rapid scanning capability enhance laboratory productivity. Integrated software solutions streamline validation and maintain data integrity per global regulatory requirements.

Benefits and Practical Applications

Implementing these systems reduces maintenance and revalidation costs, shortens qualification timelines, and improves accuracy in routine quality control. The versatile design supports diverse analytical workflows in pharmaceutical development, QA/QC, and regulatory compliance labs.

Future Trends and Potential Applications

Advancements may include automated qualification routines, integration with laboratory information management systems, and enhanced data analytics driven by AI. Expanded spectral libraries and real-time monitoring could further optimize UV-Vis workflows across industries.

Conclusion

The Agilent Cary 60 and Cary 3500 UV-Vis spectrophotometers are fully equipped to meet the new USP General Chapter <857> and Ph. Eur. Chapter 2.2.25 requirements. Their robust performance, long-lived lamp technology, and regulatory-ready software make them ideal choices for modern pharmaceutical laboratories.

Reference

USP General Chapter <857>; Ph. Eur. Chapter 2.2.25, 10th Edition; Agilent Technologies Application Note 5994-1613EN, 2019.