UV/Vis Pharmacopeia Performance Verification on Lunatic & Stunner

Significance of the topic

Reliable UV/Vis spectrophotometry underpins accurate quantification of proteins and nucleic acids in pharmaceutical development and QC. Meeting USP <857> and Ph. Eur. 2.2.2.25 requirements is critical to ensure instrument suitability and regulatory compliance across the drug manufacturing lifecycle.

Objectives and study overview

This technical note demonstrates how the Lunatic and Stunner UV/Vis spectrometers, combined with a dedicated Performance Verification (PV) kit and software, fulfill USP and Ph. Eur. performance verification protocols. Key goals include automating absorbance accuracy, precision, linearity, wavelength accuracy, resolution, and stray light tests, and generating audit‐ready pass/fail reports.

Methodology and instrumentation

Tests were conducted on eight instruments using eight sealed cuvettes containing certified reference materials (CRMs): acidic K₂Cr₂O₇ for absorbance tests, holmium oxide for wavelength accuracy, toluene in hexane for spectral resolution, and acetone for stray light assessment. The PV tool in the client software guided users through cuvette placement, automatically ran each test, recorded detailed results, and maintained an audit trail. Instruments feature fixed‐pathlength microfluidic cuvettes, 2 µL sample volume, dynamic range from 0.02–200 mg/mL protein and 1.5–13 750 ng/µL DNA, and compatibility with automation and 21 CFR Part 11 controls.

Main results and discussion

All Lunatic and Stunner units passed USP and Ph. Eur. criteria. Absorbance accuracy met ±0.01 A for <1 A and ±1 % for 1–2 A; precision achieved SD ≤0.005 A or RSD ≤0.5 %. Linearity across three concentration levels showed R² ≥0.999. Wavelength accuracy was within ±1 nm for 200–400 nm and ±2 nm up to 750 nm. Spectral resolution ratio exceeded 1.32, confirming SBW <2 nm. Stray light absorbance ≥3 A corresponded to <0.1 % stray light at 260, 280, and 300 nm.

Benefits and practical applications

• Streamlined compliance testing reduces manual effort and error.
• Audit‐ready reports and secure data handling support QA/QC and regulatory requirements.
• Micro‐volume analysis conserves valuable samples and accelerates throughput.
• Fixed optical pathdesign lowers maintenance and improves reproducibility.

Future trends and possibilities

Integration with advanced laboratory automation and expanded 21 CFR Part 11 capabilities will further enhance workflow efficiency. Developing new CRMs and software algorithms could extend applicability to small molecule and materials analysis. AI‐driven diagnostics may soon enable predictive maintenance and real‐time performance optimization.

Conclusion

The Lunatic and Stunner UV/Vis systems, with their dedicated PV kit and software, offer an efficient, automated solution for verifying spectrometer performance in full compliance with USP <857> and Ph. Eur. 2.2.2.25. Exceptional accuracy, precision, and robust audit trails ensure reliable biologics quantification across research, manufacturing, and QC environments.