+1-289-642-2696   |   info@krinslifescienceslab.ca

Stability Studies

We offer testing on a range of stability testing, including the most commonly used 5 ±3°C, 25°C/60%, 30°C/65%RH, and 40°C/75%RH. We conduct stability studies at all stages of product development.

Krins will ensure that stability studies methodology comply with ICH, US-FDA, and Health Canada and other relevant regulatory requirements/recommendations.

Our Service Portfolio Includes:

  • Stability Protocol Design and Execution
  • Forced Degradation Studies Design and Execution
  • Development and Validation of Stability Indicating Methods
  • Long Term Stability Studies
  • Intermediate Stability Studies
  • Accelerated Stability Studies
  • Photo-stability Studies
  • Customized Conditional Stability Studies
  • Formulation Evaluation Stability Studies
  • Stability Testing for R&D Stages (IND, NDA, and ANDA)
  • Commercial / Post-Market Stability Studies
  • Transportation Stability Studies (Including Simulation Studies)
  • Freeze/Thaw Studies
  • Customized Data Recording and Reporting
  • OOT and OOS Trending Reports
  • Stability Studies Summary Report Preparation
Case Study Conditions
General Long term2

Intermediate 2

Accelerated

25 °C ± 2 °C/60%
RH ± 5% RH; or
30 °C ± 2 °C/65%
RH ± 5% RH;
30 °C ± 2 °C/65%
RH ± 5% RH
40 °C ± 2 °C/75%
RH ± 5% RH
Stored in
refrigerator
Long term
Intermediate
5 °C ± 3 °C
25 °C ± 2 °C/60%
RH ± 5% RH
Stored in
freezer
Long term -20 °C ± 5 °C