Stability and Release Testing

VIMTA is one of India’s largest providers of stability testing and storage services and is trusted by organizations around the globe. We conduct stability studies as per ICH guidelines and also offer customized stability programs. Our facilities are fully compliant with GMP requirements, and have been set up after performing a thorough risk assessment.

Our state-of-the-art stability chambers, with close to ~4,50,000 Liters capacity, are equipped with advanced chiller based technologies, backup systems, redundant power backup, alarms system, and automated temp / RH excursion mobile phone notifications. All stability chambers are monitored 24 x 7 x 365 by a facility administration team through a building management system that records temperature and humidity every fifteen minutes and raises alerts according to pre-defined criteria. The chambers are managed through a robust preventive maintenance program with support of in-house engineering team as well as annual maintenance contracts by vendors. The studies include:

  • Clinical stability
  • Developmental stability
  • Follow-up stability studies
  • Registration stability studies
  • Transport stability studies
  • Freeze thaw cycling stability studies
  • Photostability studies
  • Extractables and Leachables

We offer a range of stability storage conditions as:

  • 25°C / 60 % RH
  • 30°C / 65 % RH
  • 40°C / 75 % RH
  • 25°C / 40 % RH
  • 30°C / 75 % RH
  • 50°C
  • ≤ – 70°C
  • – 20°C
  • 5°C
  • 15°C
  • Photostability

In addition to the above conditions, we can also set up stability chambers for other temperature and humidity conditions. Our stability testing laboratory is supported by wide range of instrumentation including manual, semi-automated and automated dissolution apparatus such as CALIPER Multi Dose G3, Tablet Processing Work station (TPW) for uniformity testing. Comprehensive testing capabilities include assay, dissolution, Karl Fischer, hardness, disintegration, friability and characterization of impurities and degradants.