Pharmaceutical

Drug stability testing is a critical measure to ensure that a drug maintains its physical, chemical, and biological properties over time under varying environmental conditions, such as temperature, humidity, and light. This testing not only determines a drug’s shelf life but also directly impacts its safety and effectiveness.

The internationally recognized ICH Q1 series of guidelines has become the standard for drug stability testing and has been adopted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). ICH Q1A (R2), “Stability Testing of New Drug Substances and Products,” serves as the core guideline in the ICH Q1 series. It establishes globally unified drug stability testing methods and standards, effectively promoting consistency and efficiency in global drug development.

According to ICH Q1A (R2), drug stability testing is typically conducted under the following temperature and humidity conditions:

Long-term: 25°C ± 2°C / 60% RH ± 5% RH

Intermediate: 30°C ± 2°C / 65% RH ± 5% RH

Accelerated: 40°C ± 2°C / 75% RH ± 5% RH

Pharmaceutical stability test chambers are key equipment for these tests and are widely used in pharmaceutical companies, research institutions, universities, and various laboratories. From benchtop to walk-in chambers, KOMEG can provide customized pharmaceutical stability testing solutions tailored to your specific testing needs, meeting diverse R&D and production requirements.