Gas Chromatography/Mass Spectrometry
The GC/MS group at Quantum specializes in the testing and identification of volatile and semi-volatile compounds. Employing GC/MS our scientists can test samples for identification, purity, contaminants, degradants, residual solvents and more. We have extensive experience in the application of GC/MS to solving issues of potential impurities, contaminants, and the identification of unknown peaks that appear in chromatograms. Employing GC/MS we can provide testing to support product safety concerns surrounding unwanted compounds that may pose safety and regulatory issues. Quantum has extensive experienced in the application of GC/MS in analyzing pharmaceuticals, medical devices, personal care products and cosmetics. Our GC/MS group has developed and validated numerous GC/MS methods in support of the identification and quantitation of impurities and degradants. 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.
Range of Applications
- Degradation product identification and profiling.
- Drug-excipient interaction studies.
- Deformulation of products.
- Identification of packaging extractables and leachables.
- Peak purity verifications for validation of analytical stability-indicating GC methods.
- Identification of unknown impurities arising from manufacturing processes.
- Identification and quantification of residue on equipment surfaces (i.e. surfactants, excipients, APIs).
- Reaction monitoring.
- Reaction mechanism elucidation by isotopic labeling.
- Identification and characterization of reaction intermediates and by-products.
- Process impurity identifications.
- Raw Materials Lot-Lot and Vendor-Vendor Active Ingredient (API) and impurity comparisons.
- Structural hit list screening for potent impurities (i.e. melamine, alkylating agents).
- Polymeric material characterization.
- Patent litigation support