Method development & validation

The analytical testing methods used to monitor potency and purity for raw materials, drug substances and drug products are your primary view into the quality of your materials. Cambrex focuses on efficiently developing robust and high- quality analytical methods that deliver reliable results. We have a vast range of capabilities in instrumentation and detectors including high-throughput column screening. We employ a phase appropriate validation strategy to support programs from early clinical to commercial. Our team of experts have a proven reputation for taking on tough challenges and delivering a quality method to our customers.

We have extensive experience developing and validating:

  • HPLC/UPLC stability indicating methods for assays and impurities
  • Chiral HPLC methods for enantiomer resolution
  • GC-FID methods for residual solvents
  • GC MS methods for potential genotoxic impurities (PGI’s)
  • ICP-MS method for elemental impurities
  • Discriminating dissolution methods
  • Cleaning methods
  • Counter Ion methods by titration, HPLC/UPLC or IC
  • Particle Size methods

We routinely develop methods to support:

  • Raw Material testing
  • In process testing
  • Drug Substance Release testing
  • Reference Standard Qualification
  • Final Product Release testing
  • ICH Stability Programs

Find out more

If you would like further information about our method development and validation, don’t hesitate to get in touch.

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