what is stress testing ?
Stress studies shall be conducted by using approved drug substance or product…to check it’s stability by evaluating the results of purity and % of related impurities (Known /unknown), while it is interact with different parameters like…acid, base, oxidising agent, reducing agent, light and hydrolysis.
What is the frequency of conducting these studies?
This study shall be carried out in solid and liquid states of drug .
Solid state means changes in storage temperature, % of RH. & Light.
Liquid state means drug interact with acid, base, oxidising agent…
These studies shall be carried out when there are major changes in manufacturing process like excipients/process change…And change in analytical method…