Stability Testing
Stability testing at QMEDIS Analytics: safety for your medicinal products
The stability of pharmaceutical products is a decisive factor in their quality, efficacy, and safety. In order to meet the high regulatory requirements of the pharmaceutical industry and national and international authorities, we offer comprehensive services in the field of stability testing – from study planning to evaluation.
Our service portfolio in the field of stability
- Conducting stability studies in accordance with ICH and GMP guidelines
- Long-term, intermediate, and accelerated studies under controlled storage conditions
- Ongoing stability programs for continuous monitoring of approved products
- Planning and implementation of stability studies
- Stability-indicated analysis for the identification and quantification of degradation products
Wir führen Stabilitätsstudien nach ICH durch und decken dabei relevante Klimazonen ab:
- 2 °C - 8 °C
- 25 °C / 60% RH – long-term condition (climate zone II)
- 30°C / 65% RH – intermediate condition (climate zone IVa)
- 40°C / 75% RH – accelerated condition
We also have the necessary infrastructure for stability testing of cannabis-based medicines and narcotics.
Our equipment – your safety
With state-of-the-art analytical methods (e.g., HPLC, GC, UV/Vis, NIR, MIR) and ultra-modern climate chambers, we guarantee reproducible, reliable, and GMP-compliant results – in compliance with all regulatory requirements (including ICH Q1A–Q1E).
Your added value
From study design and analytical support to the preparation of regulatory-compliant reports, we support you every step of the way to reliably demonstrate the stability and shelf life of your active ingredients and finished drugs.
QMEDIS Analytics GmbH – your partner for stability testing and safe drugs throughout the entire product life cycle.