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what is stability study ? why it is needed and how itis done
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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
| Is This Answer Correct ? | 55 Yes | 3 No |
Answer / sarma dvv
Stability means how long the drug was stable with out
losing original character.
drug compound will decompose at different environmental
conditions such as temperature,humidity & light....
From stability we can know thefollowing things
1.Re-test period of the drug.
2.Packing conditions of the drug.
3.Storage conditions of the drug(Temp and humidity)
Typical stability storage conditions of the drug.
1)accelerated Studies 40°c & 75 Relative Humidity
2)Intermediate studies 30°c & 65 Relative Humidity
3) Real time studies 25°c & 60 Relative Humidity.
| Is This Answer Correct ? | 46 Yes | 2 No |
USP methodology, EP methodology, IP methodology, among three if possible to use one methodology for qualify working standard to use USP, EP, IP ? Please explain...
0 Answers Srini Pharmaceuticals,
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