Spectroscopy Solutions for Pharmaceuticals

Significance of the Topic

UV-Vis spectroscopy plays a key role in pharmaceutical research, QA/QC and clinical chemistry. Adherence to USP<857> ensures reliable performance through design qualification, lifecycle management and periodic verification of instrument accuracy, precision, stray light and resolution.

Objectives and Study Overview

This white paper reviews the revised USP<857> performance criteria for UV-Vis instruments and demonstrates how the Agilent Cary 60 UV-Vis spectrophotometer with Cary WinUV software automates and simplifies compliance testing.

Methodology and Used Instrumentation

The study follows USP<857> protocols for operational qualification across four performance areas:

• Wavelength control: accuracy and precision tests using holmium perchlorate and didymium standards
• Absorbance control: photometric accuracy and precision tests with potassium dichromate and NIST filters
• Stray light assessment: %T measurements at specified wavelengths using defined test solutions
• Resolution evaluation: toluene in hexane spectrum analysis at 269 and 266 nm

Instrumentation:

• Agilent Cary 60 UV-Vis spectrophotometer with Xenon flash lamp
• Agilent Cary WinUV software Validate application on Windows 10

Main Results and Discussion

The Cary 60 UV-Vis consistently met USP<857> tolerances:

• Wavelength accuracy within ±1 nm (200–400 nm) and ±2 nm (400–700 nm); precision SD < 0.5 nm
• Photometric accuracy for UV (<1 Abs ±0.01; >1 Abs ±1%) and visible ranges with precision SD within defined limits
• Stray light below prescribed transmission thresholds at 198, 220, 320 and 370 nm
• Resolution ratio at 269/266 nm in line with requirements

The Cary WinUV Validate application automates data acquisition, tolerance checks and report generation, reducing manual effort and error risk.

Contributions and Practical Applications

Routine automated OQ testing enhances laboratory efficiency and data integrity. The integration of preconfigured methods and electronic records supports regulatory compliance and streamlines maintenance and troubleshooting.

Future Trends and Potential Applications

Advances may include cloud integration for remote monitoring, AI-driven anomaly detection, portable UV-Vis devices for field QC, expanded CRM libraries and enhanced software modules for seamless LIMS interaction.

Conclusion

The Agilent Cary 60 UV-Vis with Cary WinUV software offers a comprehensive, automated solution for meeting USP<857> performance requirements, ensuring accurate, precise and reliable UV-Vis measurements in pharmaceutical settings.

References

• Support for Title 21 CFR Part 11 and Annex 11 Compliance: Agilent Cary WinUV Pharma, Agilent Technologies White Paper, Publication 5991-7268EN (2016).