Product Stability Testing

Overview

Scientists at McKinney Specialty Labs have extensive expertise developing and performing stability testing programs that fulfil national and international regulatory requirements. We provide a well-controlled, and clearly documented process for all of our stability studies, with thorough record keeping and reporting. Our scientists have implemented product and aerosol stability programs for manufacturers, government and academic institutions.

McKinney Specialty Labs can also support study design and management of forced degradation studies to assess the “stability-indicating” power of the analytical methods under development for stability testing.

Testing Details

Storage Conditions for Stability Projects

  • 25 °C ± 2 °C/60% RH ± 5% RH (Standard)
  • 40 °C ± 2 °C/75% RH ± 5% RH (Accelerated)
  • -20 °C ± 5 °C (Control)
  • 30 °C ± 2 °C/65% RH ± 5% RH
  • 40 °C ± 2 °C/25% RH ± 5% RH
  • 30 °C ± 2 °C/75% RH ± 5% RH
  • 25 °C ± 2 °C/40% RH ± 5% RH
  • 22 °C ± 2 °C/60% RH ± 5% RH