Analytical Solutions

The product development and regulatory documentation is ably supported by robust and reproducible analytics through our partner companies. Modern HPLC systems are employed and the areas of expertise include:-

  • Analytical Method Development & Validation
  • Dissolution Method Development & Validation
  • Comparative Dissolution Profiling
  • Residual Solvent Method Development & Validation
  • Extractable & Leachable testing
  • Stability testing including photo stability testing as per ICH and stability testing for zone IV (B). The stability testing is carried out in stability chambers having compliant data acquisition and monitoring software for accurate and precise conditioning. The stability studies include preparation of stability protocols for Zone specific analysis with tracking and trending
  • Impurity Profiling & Characterization on LC – MS – MS