Stability Studies

Stability Studies

Kemwell provides complete stability testing and storage services for your product, in all ICH conditions, as well as custom conditions. From Pre-clinical study supplies, clinical trial supplies, to commercial launch supplies, we can work with your protocol or develop one for you.

  • IND Stability testing
  • NDA Stability testing
  • ANDA Stability testing
  • Formulation prototype stability
  • Preclinical & Clinical stability
  • Method transfer and qualification
  • Stability protocol generation
  • Stability data compilation
  • Sample storage
  • Statistical evaluation of stability data
Stability storage

At Kemwell, our cGMP stability storage facilities include 21 CFR part 11 compliant walk–in and reach–in chambers. Stability studies are routinely performed at various time points under conditions of different temperature and humidity (Real time, Accelerated and Stress studies as per ICH guidelines). Storage conditions meet the ICH standards, including:

  • 25°C/60%RH
  • 30°C/65%RH
  • 40°C/75%RH
  • 2°C – 8°C
  • Light (controlled humidity)
  • Freeze-thaw cycling (-20°C to +200°C)

In addition to routine stability studies, various exploratory studies are also conducted including Shear Stress, Freeze-Thaw, Container-closure, and Comparator studies.

Features:
  • Fully qualified
  • Monitored on-line
  • Redundant compressors and sensors
  • Back-up spare chambers
  • Back-up power supply