Equivalent GC systems performance for regulatory method compliance and validation

Importance of the Topic

The ability to transfer and validate chromatographic methods across different gas chromatography systems is critical for laboratories operating in regulated fields such as environmental monitoring, pharmaceutical quality control, and food analysis. Achieving equivalent performance when migrating methods reduces downtime, simplifies regulatory compliance, and ensures consistent data quality.

Study Objectives and Overview

This white paper examines the chromatographic equivalency of Thermo Scientific TRACE 1300 and 1600 Series gas chromatograph systems against common regulatory methods. Four applications are detailed: determination of gasoline range organics (GRO) in water (EPA Method 8015C and Wisconsin GRO method), residual solvent screening according to USP General Chapter <467>, separation of the 16 US EPA priority polycyclic aromatic hydrocarbons (PAHs), and analysis of 37 fatty acid methyl esters (FAMEs) by AOAC Method 996.06.

Methodology and Instrumentation

The studies employ Thermo Scientific TRACE 1310 and 1600 Series GC systems coupled to either TriPlus 500 static headspace or AI/AS liquid autosamplers and instantaneous connect split/splitless injectors with flame ionization detectors. Columns include TG-1MS, TG-624, TG-5MS, and Restek Rt-2560 capillaries. Static and valve-and-loop headspace configurations are used for volatile targets. Sample preparation follows the respective regulatory protocols: aqueous headspace extraction for GRO, limit and quantitative tests for residual solvents, direct injection of PAH mixes in dichloromethane, and derivatized FAMEs in hexane/dichloromethane.

Main Results and Discussion

• GRO in Water: Full baseline separation of critical pairs (methanol/MTBE Rs=31.4, ethylbenzene/m,p-xylene Rs=1.9) within 12.5 minutes. Calibration linearity R2>0.9995, LOQ ≤7 μg/L, recoveries between 91-97%, repeatability <4% RSD.
• USP<467> Residual Solvents: Class 1 and Class 2 solvent screening met system suitability for signal-to-noise and critical pair resolution (acetonitrile/dichloromethane Rs>1.0). Limit tests and confirmation complied with both Procedure A/B and quantitative Procedure C.
• US EPA 16 PAHs: A 2 μL splitless injection of a 1 μg/mL standard achieved chromatographic resolution Rs≥1.0 for all PAH pairs using TG-5MS column, with complete elution in 20 minutes.
• FAMEs by AOAC 996.06: Separation of 37 FAME components on a 100 m Rt-2560 capillary provided Rs≥1.0 for the critical C18:3–C20:1 and C22:1–C20:4 pairs, enabling precise integration and quantitation of saturated, monounsaturated, and polyunsaturated fatty acids.

Benefits and Practical Applications

• Streamlined method transfer between different GC platforms and brands using consistent hardware configurations and consumables.
• Regulatory compliance support for environmental, pharmaceutical, and food laboratories with minimal revalidation efforts.
• Improved laboratory productivity by reducing method transfer time and ensuring reproducible, high-quality chromatographic data.

Future Trends and Applications

• Integration of advanced automation and digital connectivity for remote monitoring and cloud-based data management.
• Coupling of optimized GC workflows with mass spectrometry detectors or multidimensional separations for enhanced selectivity and sensitivity.
• Application of machine learning tools for real-time method optimization, predictive maintenance, and automated compliance reporting.

Conclusion

Thermo Scientific TRACE 1300 and 1600 Series GC systems demonstrated robust chromatographic equivalency across four key regulated methods. Consistent performance metrics such as resolution, linearity, sensitivity, and repeatability confirm these platforms as reliable choices for routine analysis in regulated environments, facilitating rapid method transfers and streamlined validation.

References

1. EMEA CHMP Guideline EMEA/CHMP/EWP/192217/2009 Rev 1 Corr 2
2. US FDA ORA Laboratory Manual Volume II, ORA-LAB.5.4.5 Methods, Revision 02, June 2020
3. United States Pharmacopeia Chapter 621, Gas Chromatography
4. EPA Method 8015C Revision 3, February 2007
5. Wisconsin DNR Modified GRO Method PUBL-SW-140, September 1995
6. Thermo Fisher Application Note AN10702: GC-HS GRO Analysis
7. ICH Q3C(R6) Guideline for Residual Solvents, 2016
8. USP General Chapter 467 Organic Volatile Impurities, USP 42–NF 37
9. Thermo Fisher Application Note AN10676: HS-GC Residual Solvents
10. Thermo Fisher White Paper 10705: Method Transfer to TriPlus HS Autosampler
11. Abdel-Shafy HI, Mansour MSM. Review on PAHs. Egyptian Journal of Petroleum 2016;25(1):107–123
12. Hussar E et al. Human Health Risk Assessment of 16 PAHs in Soil. Water Air Soil Pollut 2012;223:5535–5548
13. AOAC Official Method 996.06 Fatty Acids in Foods, 1996 (2010).