Gas Chromatography (GC) for Pharmaceutical Gas Testing
Gas Chromatography (GC) is a cornerstone technique in the analysis of process gases used in pharmaceutical and biotechnological manufacturing. It provides high-resolution separation and quantification of volatile organic and inorganic components, making it ideal for measuring purity and impurities in gases such as Nitrogen (N₂), Oxygen (O₂), Argon (Ar), Carbon Dioxide (CO₂), and USP Air.
Applications:
- Detection of hydrocarbons (methane, ethane, ethylene, propane, etc.)
- Gas mix quantification
- Analysis of residual solvents or process contaminants
- USP <467> and custom impurity profiles in compliance with ICH Q3C
Instrumentation & Configuration:
- Thermal Conductivity Detector (TCD) for permanent gases
- Flame Ionization Detector (FID) for organic vapors
- Methanizer-equipped FID for enhanced CO/CO₂ sensitivity
- Dual-column configurations for optimal separation
Gas Chromatography-Mass Spectrometry (GC-MS) for Trace Impurity Profiling
GC-MS combines the powerful separation of gas chromatography with the molecular specificity of mass spectrometry, enabling ultra-trace detection and definitive compound identification. This is critical when characterizing unknown contaminants or confirming the identity of regulated impurities in high-purity gases.
Applications:
- Confirmatory identification of impurities flagged during GC screening
- Detection of sub-ppb organic contaminants
- Forensic analysis of gas-related failures or off-spec conditions
- VOC (volatile organic compound) fingerprinting
Instrumentation & Features:
- Electron Impact (EI) ionization for robust fragmentation
- Selected Ion Monitoring (SIM) for enhanced sensitivity
- High-resolution time-of-flight (TOF) MS available for isobaric compounds
