Forced degradation studies degradant identification

Procedure or forms for investigating, reporting, corrective action Forced degradation/stress studies Material to be tested Conditions Extent of degradation Identification of degradants Switch to ICEI conditions Allowable circumstances Procedure... 

Moreover, if adequate forced degradation studies (i.e., acid/base hydrolysis) are performed in the early preformulation stage, the identification of a potential degradation product that might arise during excipient compatibility... 

I. Case Study B.l Identification Using a Combination of Enriched Forced Degradation Samples and Normal-Phase HPLC... 

The forced degradation studies should be part of impurity characterization. When identification of the impurity is not feasible, incorporate the description of unsuccessful experiments (including those conducted in stress-testing studies) in the text of the application. The most frequently encountered protein variants include truncated fragments, deamidated, oxidized, isomerized, aggregated forms, and mismatched disulfide links. 

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