Nitrosamine risk assessment

Nitrosamine risk assessment

How Can Excipients Contribute to Nitrosamine Risk in Drug Products?

How Can Excipients Contribute to Nitrosamine Risk in Drug Products?

When pharmaceutical teams investigate nitrosamine risk, attention often begins with the active pharmaceutical ingredient (API) and its manufacturing process. But the API is only part of the picture. Excipients can contribute to nitrosamine risk by introducing trace nitrite or other relevant precursors into a drug product. When those precursors encounter a susceptible amine under favorable […]
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Extractables, Leachables, and Nitrosamines: Where Pharmaceutical Packaging Risk Assessments Commonly Miss Risk

Extractables, Leachables, and Nitrosamines: Where Pharmaceutical Packaging Risk Assessments Commonly Miss Risk

Pharmaceutical packaging systems are designed to protect products throughout manufacturing, storage, transportation, and patient use. As a result, packaging risk assessments have become a routine part of pharmaceutical development and quality management programs. However, one important challenge remains: not all packaging-related risks are immediately visible. While many packaging assessments focus on material compatibility, stability, and […]
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