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Analytical Development

Services

  • Analytical method development for API and drug product
  • Method validation for API and drug product to support DMF/IND/CTA/NDA/ANDA applications
  • Stability studies to support development and regulatory fillings of API and drug product
  • Solid state characterization for ‘as is API’ and in drug product.
  • Cleaning methods for drug products
  • Method transfers.

Capabilities

  • HPLCs (UV and PDA detectors)
  • UV-Visible Spectrophometry
  • Differential Scanning Calorimetry
  • Dynamic Vapor Sorption/Desorption
  • Gas Chromatography
  • Particle Size Analyzer
  • Water Activity and Moisture Quantification
  • Viscosity Measurement.