Question { Dr Reddys, 27890 }

what is stability study ? why it is needed and how itis done

Answer

To provide evidence that drug product or drug compound will
show various changes at different environmental conditions
such as temperature,humidity & light....
it will done under 3 conditions
1)accelerated Studies 40 c & 75 Humidity
2)Intermediate studies 30 c & 65 Humidity
3) Real time studies 25 c & 60 humidity
Photostability studies: By using luxo meter