Module 3 Presentations

07/05/2024

Factors affecting Chemical Drug Product Stability

• Moisture • Temperature • Light levels • Oxygen • Excipients • Ionic strength • pH • Microbial contamination

The Organisation for Professionals in Regulatory Affairs

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Chemical modifications

Consequences of chemical modifications ● concentration changes – presentable as

– decrease of the quantities of source materials – increase of the concentration of reaction products – lead to a decrease of the content of active substance and to an increase of the amount of impurities – they influence the efficacy of the drug product and they increase the toxicological risk ● change in appearance, consistency, content uniformity, clarity (solution), moisture contents, particle size and shape, pH, package integrity

The Organisation for Professionals in Regulatory Affairs

30