Gas Chromatography

Gas Chromatography Lab

 

Our scientists have a wide breath of experience and knowledge in the application of Gas Chromatography (GC). We have experience in the use of both modern capillary column gas chromatography, as well as older packed column gas chromatography. Our laboratories maintain a significant inventory of both capillary and packed columns, including many difficult to find packed column phases.  Our GC group provides comprehensive analytical testing in support of active pharmaceutical ingredients (API), intermediates, raw materials, in-process samples and finished products. We have developed and validated numerous GC methods in support of assay, purity, residual solvents, and impurity identification. And, have supported the development and validation of such methods for CMC and other regulatory submittals. Over the years, our analytical team has successfully developed-validated-transferred in excess of 2,000 chromatography (LC/GC/MS), spectroscopy (AAS/ICP/ICP-MS) or other chemistry analytical procedures, including several now in the USP

Instrument Capabilities

Agilent(3), Shimadzu(2) and Varian(2) Gas Chromatographs featuring:

  • Flame Ionization, Thermal Conductivity and Electron Capture Detectors
  • Direct injection including cool on column injection
  • Static Headspace
  • Chemstation with Electronic Records and Signatures

Services

The GC lab provides an array of analytical testing services including but not limited to:

  • Established Compendial methods (USP/NF, EP, JP, BP, FCC, ACS, etc)
  • Client supplied methods
  • Method Development, Validation, and Transfer (including protocol development and report generation)
  • USP <467> Residual Solvents Testing (including method evaluation, feasibility and development/validation studies, as needed)
  • Stability testing of Drug Substances and Drug Products
  • Chromatographic Purity
  • Assay
  • Chromatographic Limit Tests

See GC Case Studies