Drug product physical properties stability studies - which properties to test?

sidmishra - 2008 · Jun 24, 2008

hi
can anybody tell me what are the different parameters for testing physical properties of a sample in stability study of a drug product.

Scott Catron · Jun 24, 2008

Re: stability

From Q1A(R2) Stability Testing of New Drug Substances and Products (PDF document):

Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy.

We do aqueous topical antimicrobials, so we check active ingredient assay, appearance, pH and viscosity.

Edit: I moved this to the FDA forum.

Drug product physical properties stability studies - which properties to test?

sidmishra - 2008

Scott Catron

True Artisan

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