STABILITY STUDY

The conditions under which drug substance and drug products are manufactured, transported and stored can influence their efficacy. Stability studies in the pharmaceutical industry help to estimate the impact of transportation and storage on drug performance by stressing materials under exaggerated environmental conditions. Throughout the world, there are 5 different ICH Stability Zones:

Climatic Zone

• Zone I
• Zone II
• Zone III
• Zone IVa
• Zone IVb

Type of Climate

• Temperate
• Mediterranean/Subtropical
• Hot, Dry
• Hot Humid/ Tropical
• Hot/ Higher Humidity

Long term Stability Testing Recommended Conditions

• 21°C/45%RH
• 25°C/60%RH
• 30°C/35%RH
• 30°C/65%RH
• 30°C/75%RH

We offer the following stability conditions for pharmaceutical stability storage:

• 25°C ± 2°C / 60% RH ± 5% RH  (Long Term Testing)
• 40°C ± 2°C / 75% RH ± 5% RH  (Accelerated Testing)
• Photostability  ( UV and Visible Exposer)