what is stress testing ?
Stress studies shall be conducted by using approved drug substance or productā¦to check itās stability by evaluating the results of purity and % of related impurities (Known /unknown), while it is interact with different parameters likeā¦acid, base, oxidising agent, reducing agent, light and hydrolysis.
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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 agentā¦
These studies shall be carried out when there are major changes in manufacturing process like excipients/process changeā¦And change in analytical methodā¦