Stability testing
& storage

Throughout the product life cycle, we provide ICH-compliant stability programs, comprehensive stability testing, and sample storage that accommodates both standard temperature ranges and special product requirements.

lab worker doing ich-compliant stability programs
lab workers discussing stability storage data
Stability studies

Gathering critical product data

Stability is a key focus of our analytical scientists. They carefully evaluate both APIs and drug products under a variety of conditions, assessing their shelf-life, collecting regulatory data, establishing optimal storage conditions, and defining shipping and distribution parameters.

Our experts can conduct these stress-tests using a broad portfolio of analytical methods:

  • Real-time: Testing your product under intended temperature, humidity, and packaging storage conditions
  • Accelerated: Gathering supportive data through estimations of long-term testing outcomes and evaluation of short, temporary excursions from label storage conditions (e.g., during shipping)
  • Intermediate: Performed between long-term and accelerated studies when accelerated studies show potential for significant change after 6 months
pharma worker with stability testing data from stability program
Regular assessment

Testing stability along the way

Whether your product is in clinical development, under regulatory review, or on the market, we monitor and verify its stability at multiple points throughout its life cycle.

In-line stability studies are typically conducted:

  • During process development for clinical batches
  • On commitment batches for approval
  • For follow-up testing during ongoing production
  • To support post-approval changes

Development-phase stability studies

Development phase stability studies
stability batches stored
Environmental variables

Available storage conditions

When we perform our stability studies specified by our customers, we consider and test a variety of different temperature ranges, humidity levels, and lighting conditions.

The climate zones available at Vetter range from moderate, to subtropical, to dry heat, to intense heat. We can test in temperatures from 25° to 40°C with various levels of relative humidity, as well as cold and freezing storage conditions ranging from +2°C to -80°C.

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Interested in our services? Reach out to our team of experts to discuss how we can support you and your injectable product.

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