Stability Storage & Testing




WE SUPPORT YOUR PROJECTS

  • Clinical trials
  • Commercial
  • NDA
  • BLA
  • ANDA
  • IND

For the quality control and security your projects demand, all cGMP validated environmental chambers and our photostability chambers are monitored 24 hours a day by a computer-based Environmental Monitoring System. Our walk-in, reach-in, UV/visible and fluorescent photostability chambers are supported by back-up chambers, a reserve generator and an electronic notification system.

We have the latest Stability Laboratory Information Management System (LIMS) to ensure the highest ICH compliance. The system accommodates sophisticated sample management, as well as allows the stability department to generate cumulative reports.

COMPREHENSIVE STABILITY STUDIES AND SERVICES

  • Stability protocol generation
  • Stability testing
  • Stability storage
  • Stability summary report generation
  • Stability time points and conditions specific
    report generation
  • Preclinical stability
  • Clinical stability
  • Stability indicating method development and
    validation
  • Release testing
  • Method transfer and analyses qualification
  • Assay, impurities, dissolution, water content,
    etc. of various formulations



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STORAGE CONDITIONS

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