Stability (excluding specimen stability): This section should describe claimed shelf life, in use stability and shipping studies. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 126 of 248 16.0 Claimed Shelf life: This section should provide information on stability testing studies to support the claimed shelf life. Testing should be performed on at least three different lots manufactured under conditions that are essentially equivalent to routine production conditions (these lots do not need to be consecutive lots). Accelerated studies or extrapolated data from real time data are acceptable for initial shelf life claim but need to be followed up with real time stability studies. Such detailed information should describe: (a) the study report (including the protocol, number of lots, acceptance criteria and testing intervals); (b) when accelerated studies have been performed in anticipation of the real time studies, the method used for accelerated studies; (c) conclusions and claimed shelf life. Explanation: Shelf life can be derived from the lot with the longest real time stability data as long as accelerated or extrapolated data from all three lots are comparable.