Liquid Chromatography

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Our analytical scientists have a wealth of experience and knowledge in the application of liquid chromatography (HPLC/UPLC). We have experience in the use of numerous types of detectors, ranging from common detectors such as UV and PDA to RI, to more esoteric detectors such as ELSD, coulometric, ampeometrics and CAD. Our LC 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 LC methods in support of assay, purity and impurity chromatograph 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

  • UV Detectors
  • Photodiode Array Detectors
  • Refractive Index Detectors
  • Electrochemical Detectors
  • Ampeometric Detectors
  • Coulometric Detectors
  • Conductivity Detectors
  • Chemstation with Chemstore CDS 
  • Waters Empower 2 CDS

Services

The HPLC 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)
  • Chromatographic Purity
  • Assay
  • Chromatographic Limit Tests
  • Stability testing of Drug Substances and Drug Products

See HPLC Case Studies