Stability-Studies

Kemwell provides complete stability testing and storage services for your product at all major ICH conditions as well as custom conditions. We can work with your protocol or develop one for you and offer services from pre-clinical study supplies, clinical trial supplies to commercial launch.

Key Stability Studies

  • Formulation prototype stability
  • Pre-clinical and clinical stability
  • Temperature excursion studies
  • IND stability
  • NDA stability

  • ANDA stability

  • Commercial stability

Prior to initiating the stability study, we develop or conduct analytical method transfer/ method qualification to ensure the methods meet pre-defined specifications for intended purposes.

We also generate stability protocols, generate and compile stability data, evaluate data, and prepare reports for regulatory submissions. 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).

The following ICH storage chambers are available:

Chambers Capacity (L)
25o/60% RH 1,24,000
30o/65% RH 52,100
30o/75% RH 1,24,000
40o/75% RH 18,000 (2)
2o – 80 8,000 and 1,000
Photostability 200
50o 100 (2)

In addition to routine stability studies, various exploratory studies are also conducted, including:

  • In-use stability

  • Hold-time stability

  • Shear stress
  • Container and closure
  • Comparator studies

Key Facility Features

  • Fully qualified as per cGMP conditions
  • Monitored on-line
  • Redundant compressors and sensors
  • Back-up power supply
    • Manufacturing

      • Process development
      • GLP Batch manufacturing
      • Scale-up / Transfer