Stability testing

The Diapharm Analytics service laboratory assists manufacturers from initial pharmaceutical development and the stability testing of bulk or final products through to in-use stability studies, stability monitoring of post-marketing batches (on-going stability testing) and testing in connection with variations.

Diapharm Analytics’ services

  • Regulation-compliant testing plans
  • Import authorisation for international projects
  • Storage according to ICH conditions
  • Coordination, analysis, evaluation and reporting
  • Efficient planning and implementation of on-going stability studies
  • QP interpretation of OOx results (OOS, OOT, OOE)

Stability testing is required in order to determine and validate the chemical and physical shelf-life under specific storage conditions (humidity, temperature). In the run-up to clinical studies, stability testing is used to ensure that the shelf life of a study drug is sufficient to last for the duration of the study. Long-term studies involving the finished product are required for marketing authorisation. Following this, manufacturers are legally obliged to undertake on-going stability studies on a regular basis, so that they are able to prove that the medicinal product in question can be used safely over the entire period of its shelf life.

Photo:  Nicole Lübben
Nicole Lübben
Senior Manager Laboratory · Diapharm Analytics
Photo:  Linda de Freese
Linda de Freese
Senior Manager Laboratory · Diapharm Analytics

ICH climactic zones for stability testing

No lifecycle without stability testing! The “expiry date” of a medicinal product not only supports the safe use of this product, but it can also open up new markets, for example, creating overseas opportunities.

Standard

  • Climatic zone II, 25°C/60% RH
  • Intermediate conditions, 30°C/65% RH
  • Accelerated testing, 40°C/75% RH
     

Refrigerated storage

  • 2°C to 8°C

 

Special climactic zones

  • Climactic zone I, 21°C/45% RH
  • Climactic zone III, 30°C/35% RH
  • Climactic zone IVa, 30°C/70% RH
  • Climactic zone IVb, 30°C/75% RH

Freezer storage

  • -20°C
  1. Contact us!
  2. Service hotline: +49 251 609350 
    +43 1 5321606 
    +31 133029063 
    +86 21 6057 7019 

  3. E-Mail: info@diapharm.com

  4. Salutation*

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