For the quality control and security your projects demand, all cGMP validated environmental and 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.

Irvine has the latest Stability Laboratory Information Management System (LIMS) to ensure 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

Storage Conditions

Range of Conditions Including all ICH Conditions

  • 25°C/60% RH
  • 30°C/65% RH
  • 40°C/75% RH
  • 25°C/40% RH
  • 40°C/25% RH
  • 25°C
  • 50°C
  • 60°C
  • Refrigerator, 5°C
  • Freezer, -20°C
  • Ultimate freezer, -70°C
  • Photostability chambers – supports ICH photostability options I & II
  • Customized conditions

Download Fact Sheet