Storage Time Prediction

Question 1

Steps of shelf life determination

Answer 1

1. The batches are divided into many portions.
2. Each portion will be kept under different elevated temperature
3. After specific time interval the concentration of API is determined
4. The graph of log CVs T for each temperature
5. The order of reaction then determined.
   6.The rate of reaction calculated
   7.Then plot the graph of log k Vs 1/T
6. Graph extrapolated to get k at any temperature to obtain the reaction
   9.Using k at room temperature to calculate the shelf life