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Analytical

SERVICE AREAS & COMPETENCES

Service Areas

CMC Package including analytical services and Stability studies

  • One-stop services with high quality and fast turn-around time
  • Strong experience and regulation knowledge contribution to IND, NDA and ANDA projects

CGMP COMPLIANT METHOD DEVELOPMENT/VALIDATION AND QUALITY STUDIES

  • Method development and validation for starting materials, intermediates, and APIs
  • Method development and validation for drug product
  • Testing and release of APIs and drug products
  • Supportive tests for process studies and manufacture
  • Identification of impurities and structure elucidation and confirmation
  • Chemical/physical characterization of APIs
  • Qualification of reference standards

STABILITY STUDIES ACCORDING ICH/FDA/CFDA GUIDELINES

  • Dedicated stability manager and facilities. Calibrated stability chamber equipped with auto-alarm and backup power systems
  • Stability studies include preparation and approval of stability protocols, sample management, sample testing, data and trend analysis and preparation of reports
  • Stability indicating method validation and transfer
  • Stability conditions include:

    -20°C

    5°C

    25°C/60%RH

    30°C/65%RH

    30°C/60%RH

    40°C/75%RH

    50°C

    Photostability

REGULATORY CMC DOSSIER PREPARATION FOR CHINA AND GLOBAL SUBMISSION