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Analytical Development

  • HPLC method development using DOE concepts (reverse phase, normal phase, and chiral separations)
  • GC and GC-HS method development (for purity and residual solvents using GC-HS)
  • HPLC method validations (purity, assay, chiral, stress studies) as per USP/EP
  • GC (purity) and GC-HS (residual solvents) method validations as per USP/EP
  • Stability studies (accelerated, long-term, intermediate, and refrigerated conditions) as per ICH guidelines and regulatory requirements
  • Stress studies and hygroscopic studies as per USP/EP guidelines

Tell us about your analytical development needs. Please fill out our inquiry form and one of our project managers will respond promptly.