Module 3 Presentations

07/05/2024

Shelf life of drugs

Qualitative characteristics of medicinal products ● content of active substance ● galenic state, including sensory perceptible properties ● microbiological quality

● toxicological quality ● therapeutic activity

Information about factors affecting stability are also available in USP 36 – „General Information / {1191} Stability Considerations in Dispensing Practice”.

The Organisation for Professionals in Regulatory Affairs

Source: Rudolf Voigt, Pharmazeutische Technologie

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Chemical modifications

Oxidation ● A chemical reaction in which an atom or ion loses electrons, thus undergoing an increase in valence.

The Organisation for Professionals in Regulatory Affairs

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