What Next if the Dissolution fails at S1, S2, or S3?

Dissolution is one of the important performance parameters of drug products. Pharmacopeia allows testing drug products thru different stages such as S1, S2, and S3 for IR and L1, l2, and L3 for modified release dosage forms.
Sometimes, the dissolution result may not meet the acceptance criteria defined at various stages due to analytical variation or process variation. Let us understand how this dissolution failure at various stages can be handled.
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Regards
Bhaskar Napte
#dissolution #PharmaGrowthHub #analyticalchemistry #pharma

[@thirupugazhmg674]

Thanks for sharing great things sir
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[@sharmilasenthil928]

Thank you for the clear explanation sir

[@venkatpapanaboina5046]

Good explanation

[@egrettheliquiddetergent4127]

Very useful

[@arvindsingh7405]

Sir , if all six unit failed to comply the Q, then there is need to go for S2 stage or investigate the error raisin OOS..PLZ let me understand

[@pharmapreparations]

In this case investigation complete using oos

[@MethaguVe-pf1bn]

Sir, can you have me the explanation pdf

[@YogeshKumar-fr1uy]

SIR WHAT IF WE GET A RESULT IN S1 that is out of limit of S3 that is suppose 50% what to do in that case.

[@pharmagrowthhub3083]

You have to raise an OOS

[@pharmapreparations]

This is case of OOS