ICH Stability Testing and Storage

Stability studies of biopharmaceuticals are an essential component of pharmaceutical development, providing critical data on the stability and shelf-life of your biological. ICH stability studies are conducted to evaluate the stability characteristics of pharmaceutical products under various storage conditions, such as temperature, humidity, and light exposure. These studies provide valuable insights into the degradation kinetics, shelf-life, and storage recommendations for biopharmaceutical products.

At Eurofins BioPharma Product Testing, we provide comprehensive ICH stability study services to support our clients in ensuring the quality, safety, and efficacy of their products throughout the product lifecycle. Our stability storage chambers are designed to cover different temperatures, humidity, and light stability testing and are fully controlled, with 24/7 monitoring and alert system.

ICH stability studies are conducted according to ICH stability guidelines such as ICH Q1A (R2) at the below mentioned standard temperatures:

We can discuss with you about conditions such as low temperature storage and non-standard temperature/humidity conditions upon request.  

We provide an extensive array of functional, microbiological, and protein analyses to evaluate the stability of your product in line with GMP standards. From drafting protocols to delivering final reports, our comprehensive project management includes expert guidance and support throughout the process.

Contact us today to learn more about our services and how we can support your product development and regulatory compliance goals.

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