Stability testing is a vital part of product development, detailed study protocol should be conducted in consideration of relevant guidelines.
Stability testing and stress testing (forced degradation studies) should be started ideally during development phases as soon as early development material is available. This not only allows to identify the most robust and stable formulation but also ensures the product will remain stable when used in the lab, during shipments, on storage and in use. Moreover, stress testing will generate by-products that are the basis for a robust and reliable analytical method development programme.
Rodon provide a the range of ICH stability conditions to meet your requirements. Additionally, as part of analytical services, Rodon carries out the development of test methods and protocols to monitor the stability of your product.
Evaluation of identity, purity, integrity, and potency of the product is conducted according to a defined schedule. Rodon is able to conduct real time and accelerated studies based on an agreed study plan of storage conditions, sampling time and testing methods.
Our experience team will help design the study to assure it is conducted under the appropriate conditions for your product. A full range of analytical methods can be incorporated including in-vitro bioassays for evaluation of activity / function.
Our stability studies include:
• Stress testing;
• Shelf life;
• In-use studies.
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Looking for additional services? We offer even more services than listed, contact us to find out how we can assist you. Using latest advances in Protein Technologies Rodon Biologics strives to provide the highest quality custom protein services in the industry. We work closely with you, analyze your project at the planning stage and take several approaches to ensure you get the results you are looking for.Know More