Purpose of API stability study
Contribution from Arun David written on 4/11/2012 at 11:17
Since formulators establish shelf life of the drug product, what will be the purpose of the API stability study. Is it to establish the stability of the API during transport and holding in the formulator's warehouse? In this case, there won't be necessity for very high retest for the API. MAximum a year or two will suffice.Anyother purpose for stability study?
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