Analytical development and validation

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PSR’s analytical team offers a range of standalone services and also supports our formulation development activities. The analytical teams are integrated with pre-formulation, product development and quality assurance teams to ensure effective and accelerated product development. Our teams experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities. PSR’s analytical services include:

  • API Characterization

  • Analytical Method Development and Validation (To ICH guidelines)

  • Assay, Purity and Dissolution Testing

  • Forced degradation studies

  • Cleaning verification

  • Stability testing and routine analysis