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

Importance of the topic

Alcohol-based hand sanitizers are critical in reducing the spread of infections, including COVID-19, when soap and water are not available. Rigorous screening for toxic impurities such as methanol, 1-propanol, and benzene is essential to ensure product safety and regulatory compliance.

Objectives and study overview

This application note evaluates a rapid GC-MS workflow based on the U.S. FDA direct injection method for simultaneous determination of ethanol or isopropanol content and harmful impurities in finished hand sanitizer products.

Used instrumentation

• Thermo Scientific TRACE 1310 Gas Chromatograph with SSL split inlet and LinerGOLD precision liner
• Thermo Scientific AS 1310 liquid autosampler with cold needle injection and fixed-needle syringe
• Thermo Scientific ISQ 7000 single-quadrupole Mass Spectrometer equipped with NeverVent technology and ExtractaBrite source
• Thermo Scientific TraceGOLD TG-624 SilMS column (30 m × 0.25 mm × 1.4 µm)
• Chromeleon CDS software v7.3 for data acquisition and compliance with 21 CFR Part 11

Methodology and instrumentation

Samples and mixed-stock and spiked standards were prepared in HPLC-grade acetonitrile according to the FDA template. Separation was achieved with a 15 min GC run: initial hold at 40 °C, 30 °C/min to 240 °C. MS acquisition was performed in full scan (m/z 25–110) with 70 eV EI. System suitability and recovery tests followed FDA criteria, with blanks, standards, un-spiked and spiked samples bracketed by standards.

Main results and discussion

• All target compounds eluted within 9 min, with baseline resolution (Rs>1.5) except benzene/isobutanol resolved by extracted ions.
• Peak asymmetry factors were <1.2, confirming column and system inertness.
• System suitability: peak area RSD <5.5% (n=6) and recoveries 80–120% for all impurities.
• Calibration linearity was excellent (R>0.999, AvCF RSD<5.3%) over defined ranges; LODs were well below interim FDA limits.
• No level 1 impurities were detected in commercial samples; low 1-propanol traces in the isopropanol product were below the FDA interim limit.
• Ethanol and isopropanol assay results matched label claims (101% and 89% v/v, respectively).
• Method robustness verified over five days and >120 injections with RSD<10% for level 1 impurity quantitation.

Benefits and practical applications

• High throughput: short cycle time and fast sample turnaround.
• Reliable compliance: full automation with Chromeleon CDS ensures traceable results under cGMP.
• Comprehensive screening: simultaneous quantitation of alcohol content and multiple toxic impurities.
• Robust performance: stable over extended sequences with minimal maintenance.

Future trends and applications

Emerging directions include integration of AI-driven peak identification, portable GC-MS systems for field testing, higher resolution and sensitivity for trace impurity analysis, and expanded eWorkflows for automated quality control across pharmaceutical and consumer safety laboratories.

Conclusion

The Thermo Scientific TRACE 1310 GC–ISQ 7000 GC-MS configuration offers a rapid, robust, and fully compliant solution for assessing alcohol content and impurities in hand sanitizers according to the U.S. FDA method. Its high throughput and automated data management support reliable quality control in manufacturing and regulatory environments.

References

1. U.S. Food and Drug Administration. Direct Injection GC-MS Method for Hand Sanitizer Impurities, 2020.
2. World Health Organization. Hand Hygiene Guidelines, 2020.
3. U.S. FDA. Warnings on Methanol and 1-Propanol Contamination, 2020.
4. United States Pharmacopeia. USP <467> Chromatography, 2017.
5. Thermo Fisher Scientific. SmartTune Wizard for GC-MS Tuning, 2018.