Stability studies

Dear Forum members,

On what basis stability conditions like Long term/intermediate/ accelerated studies can be choose for API/Drug product.
Are there any guidelines are existing, kindly give me guidance on the same.


In order to be able to reduce the amount of stability testing required, the number of different long-term testing conditions must be reduced to a suffi cient extent. This approach was proposed by Paul Schumacher in 1972 and by Wolfgang Grimm in 1986 , and in 1998 when they defined four different long-term testing conditions, which match with the climatic conditions of the target markets categorized in just four different climatic zones. This concept is described in regulatory guidelines and pharmacopoeias and has become an established standard in developing finished pharmaceutical products (FPPs).

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