Types of Stability

Types of StabilityPhysicalProduct must appear fresh, elegant and professional, as long as it remains on the shelf.

uniformity of dose content of the active ingredient especially those in multidose containers

active ingredient must be available to the patient through out the shelf life.

Ex: Organoleptic testsDissolution testDisintegration test & hardness test

Chemicalthe product should maintain its chemical integrity & labelled potency w/in specified limits, which is not less than 90% of its potencychemical causes of drug deteriorationOxidationReduction

HydrolysisRacemization- decarboxylation, formation of ppt., deterioration of hydrogen peroxide

Ex:pHHPLCSpectrophotometryThin-layer ChromatographyUV-visMicrobiological the product should maintain its sterility & antimicrobial stability w/in specified limits

The active ingredient should remain unchanged in terms of therapeutic effect.Therapeutic ToxicologicalThere should be no significant increase in toxicity of the pharmaceutical product