Method Development and Validation

Despite the promise of increased safety, yield and efficacy, analytical method development and validation can pose significant challenges during development and production of simple and complex APIs. Developing suitable and robust analytical methods requires a thorough understanding of the underlying process chemistry to account for potential process impurities that may exist, but also for potential degradants.

At Cambrex, our experts are well-suited to tackle your method development challenges. Our experienced teams are highly knowledgeable of the regulatory requirements and possess deep scientific and technical expertise to deliver solutions for your development needs. As your partner, we offer a vast range of analytical capabilities with state-of-the-art facilities housing advanced instrumentation to ensure reliable and consistent analytical results. More importantly, our team has a proven reputation for taking on tough challenges and delivering phase-appropriate methods that support programs from early pre-clinical through to commercial. When you partner with Cambrex, our teams will collaborate with you on your project and provide open communication and transparency throughout to achieve the milestones of your program.

Our extensive experience with analytical method development and validation includes the following example method types:

  • HPLC/UPLC stability-indicating methods for ID, assays and impurities
  • Chiral HPLC methods for enantiomeric purity
  • GC-FID methods for residual solvents
  • GC-MS and LC-MS methods for potential genotoxic/mutagenic impurities (PGIs/PMIs)
  • High-resolution LC-MS methods for impurity identification/quantitation
  • ICP-MS methods for elemental impurities
  • NMR methods for identification and material potency (qNMR)
  • Discriminating dissolution methods
  • Cleaning methods
  • Counterion methods by titration, HPLC/UPLC, or IC
  • Particle size methods