Forced Degradation Studies

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Is there a standardized procedure for Forced Degradation Studies? Thanks

2

There is an ICH guideline document for photostability

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073373.pdf

And here is a good paper that should point you in the right direction. Just remember to soundly rationalize the inclusion or exclusion of impurities / degradation conditions.

http://www.pcte.edu.in/jper/issues/2012-june-volume-3-issue-1/Paper-7.pdf

Hope this helps.

3

[quote=Elaine.OG]There is an ICH guideline document for photostability

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073373.pdf

And here is a good paper that should point you in the right direction. Just remember to soundly rationalize the inclusion or exclusion of impurities / degradation conditions.

http://www.pcte.edu.in/jper/issues/2012-june-volume-3-issue-1/Paper-7.pdf

Hope this helps.[/quote]

thanks ellain

4

The latest discussion on ‘forced degradation’!