Stability studies

Why are stability studies important?

Stability studies provide critical information about the stability and shelf life of drug products. These studies help ensure that drug products remain safe, effective and meet the quality standards throughout their entire shelf life.

• Product shelf life determination: Help to determine the appropriate shelf life of your drug products
• Product quality assurance: Assessment of physical, chemical and biological properties of your drug products over time under various environmental conditions, such as temperature, humidity and light exposure. Ensure that your products maintain their intended potency, efficacy and safety throughout their shelf life
• Regulatory compliance: Regulatory authorities require stability studies as a part of the approval process. These studies provide evidence to support the expiration dates and storage conditions stated on the drug labels
• Safety: By understanding the stability profile of your drug products, you can minimize the risk of adverse effects and protect patients from consuming degraded or ineffective medications
• Post-approval monitoring: Stability studies continue even after a drug product is approved for market. Ongoing stability monitoring helps you detect any changes in the stability profile over time or due to environmental factors. This monitoring ensures the continued safety and efficacy of your drug products throughout their lifecycle

Understanding our stability studies capabilities

We can support you at R&D stage and GMP manufacturing with our stability studies, including:

• Real-time stability (long term)
• Accelerated stability
• Stress stability (forced degradation)
• Photostability as per ICH Q1B
• In-use stability study

These stability studies are fully controlled and monitored (24hr/7days), with comprehensive documentation produced.

GMP stability studies are completed under a variety of conditions and we have the facilities and chambers to hold different temperature and humidity conditions.

• Cooling chambers (2-8°C)
• Deep Freezers (-20°C)
• Ultra-low temperature freezers (-80°C)
• Humidity chambers (25°C to 40°C)