Force degradation studies for MDI Formulation in Brasil

[Sylvine Pischel]

#22182

Does anyone have information/rational/experience for conducting forced degradation studies on MDI formulations to meet Brazil RDC53 regulations?

Posted on behalf of Sylvine P. at GSK.

[John O’Neill]

#22210

Hi Sylvine,

Some of these references may prove helpful. I’ll post your question in the discussion forum to see if other Stabilitarians might comment.

Best regards,
John O’Neill
StabilityHub Editor

http://docplayer.net/38760118-Forced-degradation-studies-comparison-between-ich-ema-fda-and-who-guidelines-and-anvisa-s-resolution-rdc-53-2015.html

ANVISA’s Guidance on Forced Degradation Studies Explained

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