Topic overview

Start with the big picture

Evaluation begins with physical and visual assessment: appearance and clarity can reveal haze, precipitation, color change, or phase separation, while pH and viscosity relate to stability, patient comfort, pourability, and dose delivery. Density and drug-content testing help assess formulation consistency and the amount of active ingredient. For dispersed systems such as suspensions and emulsions, particle size, dose uniformity after shaking, sedimentation, and redispersibility are relevant. Chemical stability testing tracks assay and degradation over time; stability studies examine changes under storage conditions. Microbiological checks address bioburden and, for applicable products, sterility and endotoxin. Packaging compatibility and organoleptic properties also contribute to the broader quality assessment.