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Webinar: From lab to label - Analytical method advances in measuring nitrite in pharmaceutical excipients

VideosPharmaceuticals
Mitigating Nitrosamine Risks: A Closer Look
Explore our publications about Nitrosamine mitigation.

Whilst only very low nitrosamine amounts are acceptable according to current regulatory requirements, their detection requires highly sensitive analytical methods.

About the webinar:

As clarified by the EMA, their presence in active substances may be linked to several factors, such as processing conditions, accidental introduction due to cross-contamination, recovery procedures for solvents, or from degradation of the substance. Reducing nitrite levels in excipients remains the most effective way to control the formation of nitrosamine and is a key strategy to mitigate high nitrosamine risk. As a result, excipient manufacturers have since developed accurate and sensitive methods for nitrite determination that are of vital importance for drug product producers. 
This webinar will cover key excipient supplier strategies on managing nitrite impurities.

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Mitigating Nitrosamine Risks: A Closer Look
Explore our publications about Nitrosamine mitigation.

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Webinar: From lab to label - Analytical method advances in measuring nitrite in pharmaceutical excipients | IMCD Australia