Module 3 Presentations

07/05/2024

What is stability?

Stability of a pharmaceutical product may be defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and

informational specifications . Source: Kommanaboyina et al., 1999

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What is stability?

Stability is influenced by a variety of factors: • stability of the active ingredient(s) • interaction between active ingredients and excipients • manufacturing process • type of dosage form • container/closure system used for packaging • light, heat and moisture conditions encountered during shipment, storage and handling • degradation reactions like oxidation, reduction, hydrolysis or racemization

Source: Bajaj et. al, 2012

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