Liquid Chromatography/Mass Spectrometry
Liquid Chromatography/Mass Spectrometry (LC/MS) is a technique for the separation, detection, and identification of non-volatile organic compounds (small molecules) and biologically active compounds (large molecules) such as proteins. It is a hyphenated analytical technique which couples the separating power of high performance or ultra-high performance liquid chromatography to the universal detecting power of mass spectrometry (MS). Quantex’s LC/MS group provides a range of capabilities which includes the development of custom methods to characterize molecules, formulations or solutions. Our systems are configured using three orthogonal detection methods which allows for the detection of a much wider breadth of molecules than most LC-MS systems. For molecules with chromophores, we employ detection by PDA, followed by introduction into the mass spectrometer to obtain mass and molecular data. For those molecules without chromophores, we employ detection by ELSD, followed by introduction into the mass spectrometer to obtain mass and molecular data. Using this approach our scientist are able to detect – and quantify – any organic molecule. And, employing such techiques, 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.
Agilent(1)and Thermo(2) featuring:
- Mass range 10 to 4000 Da
- ESI (Electrospray Ionization)
- APCI (Amtosphereic Pressure Chemical Ionization)
- Syringe Pump
- Standard and Well Plate autosamplers
- Fast, scan-to-scan, polarity switching for both positive and negative ions in a single analysis
- LC/MS LC/MS/MS capable
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 HPLC 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