News
11.08.2020 - Pharmacy
Stability studies and storage of pharmaceuticals
Stability studies demonstrate the quality of a pharmaceutical product and serve as a basis for determining specifications and shelf life. The impact of storage duration, temperature, humidity, and light on product quality is investigated.
The selection of the appropriate climatic zone is based on the guidelines of the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use Guidelines Q1A(R2) “Stability testing of new drug substances and products” and ICH Q1F „Stability Data Package for Registration in Climatic Zones III and IV“.
The following climatic zones are described by the WHO guideline:
- Zone I: „temperate“ 21°C/45% RH (Relative Humidity)
- Zone II: „subtropical“ 25°C/60% RH
- Zone III: „hot/dry“ 30°C/35% RH
- Zone IVa: „hot/humid“ 30°C/65% RH
- Zone IVb: „hot/very humid“ 30°C/75% RH
In addition to the long-term stability programs mentioned above, the pharmaceutical laboratories of the Tentamus Laboratory Group also offer accelerated studies at 40°C/75% RH.
We plan your stability study together with you and support you with analytical expertise and years of experience until the market launch and beyond with on-going stability studies.
Do you have questions about the points mentioned above? Contact us and feel free to reach out to your BAV customer advisor at any time. We look forward to hearing from you!