ICH Stability Testing

The Necessity of ICH Stability Testing

Stability studies were designed for monitoring and evaluating the quality of Active Pharmaceutical Ingredients (API) and Finished Pharmaceutical Products (FPP) under the influence of different factors such as environmental conditions (temperature, moisture, light), API–excipients interactions, packaging materials, shelf life or container-closure systems during a certain period. According to international guidelines (ICH, FDA, and WHO), stability studies must be performed on drug substances (DS) and drug products (DP) to ensure the quality and efficacy of the drug throughout its life cycle in a more efficient and time-saving manner. Overall, ICH stability testing is a critical component of the drug development process that ensures the integrity and reliability of pharmaceutical products, ultimately safeguarding patient health and well-being.

Explore Our ICH Stability Testing Services

As the world's leading provider of CMC analytical testing services, CD Formulation provides our customers with unparalleled ICH stability testing services. Our analytical laboratory is equipped with state-of-the-art equipment and an on-site stabilization chamber that meets ICH requirements for all stability testing conditions to ensure your product is tested in the most stable environment.

Importantly, we are able to set up the specific storage conditions and environment for your product as described in the guide. Our wide range of analytical services includes the development and validation of analytical methods for stability testing, real-time and long-term stability studies, photostability studies, forced degradation studies, etc.

List of available ICH stability testing services:

• Analysis method development and verification services for ICH stability testing.
• Stability testing services for raw materials, finial drugs, and preparations
• Long-term stability testing
• Intermediate stability testing.
• Accelerate stability testing.
• In-use stability testing.
• Follow-up stability testing.
• Formulation stability testing.
• Forced degradation testing.

• Hydrolysis (exposure to acidic, alkaline).
• Oxidation (oxidizing stresses).
• Photolytic (exposure to light).
• Thermal (exposure to heat).

• ICH photostability (fluorescent and ultraviolet (UV).
• Extractables/Leachables.
• Biological product stability studies.
• Freeze/Thaw temperature cycle test.

Available ICH Stability Test Conditions

• 21°C/45% relative humidity
• 25°C/40% relative humidity
• 25°C/60% relative humidity
• 30°C/25% relative humidity
• 30°C/35% relative humidity
• 30°C/65% relative humidity
• 30°C/75% relative humidity
• 40°C/75% relative humidity
• 40°C/NMT 25%RH
• Cabinet 50 °C, 57 °C, 60 °C
• Store at 2-8°C
• Ultra-low temperature storage -20°C, -40 °C, -80 °C

Why Choose CD Formulation for ICH Stability Testing?

• Flexible, tailor-made solutions that adhere to stability testing guidelines in a variety of projects and environments.
• Simulate all testing conditions for APIs, final products, and formulation from manufacturing to final application.
• Analyze changes in APIs, finished products, and preparations under different temperatures, humidity, and light.
• Recommended retest periods, shelf life, and storage conditions for APIs, finished products, and preparations.
• Verify that pharmaceutical products comply with regulatory requirements throughout the entire production cycle.

CD Formulation's team of experienced scientists and technicians use advanced analytical techniques to test the stability of your products and regularly update stability data as needed to meet changing regulatory requirements. Please contact us to learn more about our services and technical advantages!