Stability studies

Stability studies are among the mandatory requirements before introducing medicines to the pharmaceutical market.
Their primary goal is to determine the shelf life and storage conditions of medicines to ensure the proper quality, efficacy, and safety of each batch of the medicine until the expiry date indicated on the packaging.

To ensure comprehensive product service, we conduct durability tests of seasonally stored products under controlled conditions in climate chambers. We offer storage of samples in climate zones II and IV:

• under long-term conditions (25°C/60%RH) [climate zone II]
• under long-term conditions (30°C/75%RH) [climate zone IV]
• under intermediate conditions (30°C/65%RH)
• under accelerated conditions (40°C/75%RH).

We also have a climate chamber for photostability testing (with light).

All climate chambers are qualified and operate within the GMP system, with temperatures inside the chambers being continuously monitored by an internal system.

Stability studies are conducted based on ICH guidelines (Q1A-Q1F) and WHO Annex 2.

Taking into account temperature and humidity, stability studies of a drug can be divided into three basic types:

1. Long-term study, which is conducted over the specified shelf life of the medicine under the conditions recommended on the package leaflet and product label.
2. Accelerated study, which involves subjecting the medicine to chemical reactions and varying temperatures and humidity levels. The aim is to check the stability of the medicine when stored in conditions that do not comply with the manufacturer’s recommendations (e.g., to verify whether the medicine changes its properties during transport).
3. Intermediate study, which is conducted at a temperature of 30°C and a humidity of 65% RH.