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Residual Solvents

GC Analysis of Organic Solvents

Principle

Gas chromatography (GC) with headspace sampling detects and quantifies residual organic solvents in the final peptide product.

Common Solvents Tested

Solvent Source Limit (ICH Q3C)
Acetonitrile HPLC purification ≤410 ppm (Class 2)
TFA Cleavage/purification Specific limit
Ethanol Precipitation/wash ≤5000 ppm (Class 3)
Diethyl ether Precipitation ≤5000 ppm (Class 3)
Acetone Equipment cleaning ≤5000 ppm (Class 3)

Method

  1. Weigh sample into headspace vial
  2. Heat to 80–100 °C
  3. Inject headspace into GC
  4. Separate on GC column
  5. Detect by FID or MS

Acceptance Criteria

Class Limit
Class 1 (avoid) Not detected
Class 2 (limit) Per ICH Q3C
Class 3 (low toxic) ≤5000 ppm
  • GC Analysis of Organic Solvents — Review the section above for key parameters, methods, and quality criteria.
  • Common Solvents Tested — Review the section above for key parameters, methods, and quality criteria.
  • Acceptance Criteria — Review the section above for key parameters, methods, and quality criteria.

Key Takeaways

  • GC Analysis of Organic Solvents — Review the section above for key parameters, methods, and quality criteria.
  • Common Solvents Tested — Review the section above for key parameters, methods, and quality criteria.
  • Acceptance Criteria — Review the section above for key parameters, methods, and quality criteria.

🔗 Related: Peptide Content | Water Content | COA Understanding