Drug Stability Testing
Our drug stability testing service includes release testing and ICH stability testing. These crucial steps are vital in ensuring the quality and safety of your final product.
However, drug stability testing often presents considerable challenges due to its exhaustive testing demands. Substantial expertise and resources are required, as non-standard and specialized conditions for ICH stability testing can add further complexity to the process.
Collaborating with us means leveraging our extensive capabilities, cutting-edge equipment, and, above all, decades of invaluable experience. Our specialists are committed to working with you to develop the most efficient drug stability testing strategy to advance your product’s progress.
We offer comprehensive release and recurrent testing, including method establishment, raw material testing, in-process chemistry testing, API and drug product release testing, ICH stability testing, and comparator testing.
As a renowned provider of exhaustive analytical testing, our team is dedicated to ensuring a smooth method onboarding process, leading to the development of reliable methodologies at our sites and robust support for your program.
Our aim is to guide you through the process of drug stability testing and ICH stability testing, making it more efficient and less complicated.
Our Network for Drug Stability Testing Services
Stability Testing:
• Stability testing for climate areas II, IVa, and IVb
• Alarm-controlled monitoring of temperature and humidity
• Computer-aided time schedule and data control
• Stability tests during the clinical development and marketing stage
Stability Testing:
• Stability testing for climate areas II, IVa, and IVb and semi-permeable
• Alarm-controlled monitoring of temperature and humidity
• Stability tests during the clinical development and marketing stage
Stability Testing:
• Stability testing for climate areas II, IVa, and IVb
• Alarm-controlled monitoring of temperature and humidity
• Computer-aided time schedule and data control
Our stability studies provide long-term storage solutions under ICH conditions, ensuring the reliability and safety of your products. With precise analytical testing at key stability points, we help ensure compliance and maintain product quality throughout the entire product lifecycle, from development and production to distribution.
Stability Testing:
• Long Term Stability Storage under ICH Conditions
• Analytical Testing at Intermediate and Final Stability Points
Methods Suitability Testing:
• HPLC Validation: Ensuring accurate and reliable results through high-performance liquid chromatography validation.
• Sterility Suitability Testing: Guaranteeing sterile products and product safety throughout their life cycle.
• Endotoxin Suitability Testing: Confirming the effectiveness of endotoxin testing to ensure product safety and compliance.
• Bioburden Suitability Testing: Ensuring accurate microbial detection in compliance with current regulations.
