Rapid GC-MS assessment of hand sanitizers according to the U.S. FDA method

Importance of the Topic

Hand hygiene is critical to infection control, and alcohol-based sanitizers play a vital role where soap and water are unavailable. Ensuring these products meet regulatory standards for alcohol strength and absence of toxic contaminants is essential to safeguard public health, particularly during pandemics.

Objectives and Study Overview

This study evaluates a rapid GC-MS protocol, adapted from the U.S. FDA guidance, for simultaneous determination of ethanol or isopropanol content and toxic impurities in finished hand sanitizer formulations. The goal was to demonstrate compliance with interim impurity limits and verify alcohol strength claims using a single-quadrupole mass spectrometer coupled to fast GC.

Methodology and Instrumentation

Samples and standards were prepared following FDA recommendations, including dilutions and spiking for recovery tests. A Thermo Scientific TRACE 1310 gas chromatograph equipped with an AS 1310 liquid autosampler and a TG-624 SilMS capillary column was coupled to an ISQ 7000 single-quadrupole MS with NeverVent technology. Chromeleon CDS software controlled the system and handled automated data processing, ensuring compliance with 21 CFR Part 11.

Used Instrumentation

• GC: Thermo Scientific TRACE 1310 with SSL inlet, 30 m × 0.25 mm × 1.4 µm TG-624 SilMS column
• Autosampler: AS 1310 liquid sampler with fixed-needle syringe
• MS: Thermo Scientific ISQ 7000 single-quadrupole with ExtractaBrite source and NeverVent technology
• Software: Chromeleon Chromatography Data System (v7.3)

Main Results and Discussion

All target compounds eluted in under 9 minutes with Gaussian peaks and baseline resolution, except benzene/isobutanol which were distinguished via extracted-ion chromatograms. Calibration curves (six levels, triplicate injections) were linear (R > 0.999) with detector response RSD < 5.3%. Limits of detection met FDA criteria. Recoveries for spiked impurities ranged 80–120% with peak area RSD < 5.5%. No level 1 impurities were found in commercial products; trace 1-propanol appeared in the isopropanol-based sanitizer but remained below interim limit. Measured alcohol content matched manufacturer claims (101% for ethanol, 89% for isopropanol). Robustness over five days showed standard injection RSD < 10% and spiked recovery deviations within ± 20%.

Benefits and Practical Applications

• High throughput analysis with sub-10-minute cycle times
• Simultaneous quantitation of alcohol content and safety-critical impurities
• Automated workflows and data integrity in compliance with cGMP
• Sufficient sensitivity to enforce regulatory limits and detect low-level contaminants
• Robust performance supports routine QA/QC in manufacturing and regulatory laboratories

Future Trends and Opportunities

Method automation and integration with laboratory information management systems will further streamline workflows. Advances in column technology and miniaturized GC-MS platforms may enable on-site or field testing of sanitizer quality. Expansion of analytical scope to other biocides and regulatory updates will drive continuous method refinement and validation of new impurities.

Conclusion

The combined TRACE 1310 GC and ISQ 7000 MS system provides a rapid, reliable, and compliant solution for comprehensive analysis of hand sanitizers. It achieves precise quantitation of alcohol strength and impurities in a single run, facilitating regulatory compliance and protecting consumer safety.

References

1. U.S. Food and Drug Administration. Direct Injection GC-MS Method for Impurities in Hand Sanitizers, 2020.
2. World Health Organization. Hand Hygiene Guidelines.
3. U.S. Pharmacopeia General Chapter <467> on Residual Solvents.
4. FDA Updates on Hand Sanitizer Quality and Methanol Testing, 2020.
5. FDA Guidance for Industry: Temporary Policy for Alcohol-Based Hand Sanitizers, 2020.