Stability and Release Testing

Overview

ICH Stability Studies Across 450,000 Litres of Chamber Capacity

VIMTA is one of India’s largest providers of stability testing and storage services, 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 were established following a thorough risk assessment.

Our stability chambers, with close to 450,000 litres of capacity, are equipped with advanced chiller-based technologies, redundant power backup, alarm systems, and automated temperature and humidity excursion notifications to mobile devices. All chambers are monitored 24 × 7 × 365 by a facility administration team through a building management system that records temperature and humidity every fifteen minutes and raises alerts against pre-defined criteria. Chambers are maintained under a preventive maintenance program supported by an in-house engineering team and annual maintenance contracts with vendors.

Studies

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

Storage Conditions

We offer a range of stability storage conditions as listed

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

Explore Stability and Release Testing services

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