Protocols forstability testing

Protocol planning for stability testing is influenced by several factors such as physicochemical properties of the drug, type of product, regulatory requirements of the intended market and the proposed uses of the data obtained. In addition to specific job requirements, the priority allocation and the availability of resources also affect the protocol design. This review describes the objects and design of protocols for stability evaluation with particular emphasis on relatively unstable compounds. The relevance of stability testing to various stages of product development is examined. Problems of shelf-life assignment, preparation of samples for inspection, use of controls and extrapolation of results are also discussed.