Module 3 Presentations

07/05/2024

Effects of environmental conditions

Climatic influences ● air humidity – presence of water may lead to hydrolytic degradation of active ingredients and excipients (  hydrolysis) – moisture causes a change of physical parameters (e.g. maceration, hardness of tablets) ● light – may lead to photolytic degradation of active ingredients and excipients (  photolysis) – promotes oxidation reactions

The Organisation for Professionals in Regulatory Affairs

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Biological influences ● insects, bacteria, viruses, fungi Effects of environmental conditions

– may lead to microbial contamination – induce impurities (e.g. due to endotoxins, metabolites and degradation products) – lead to degradation or modification of active ingredients and excipients ● chemical influences – oxygen, ozone – may lead to modification of active ingredients and excipients (  oxidation)

The Organisation for Professionals in Regulatory Affairs

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