Nitrosamines Analysis: Solutions for Risk Management and Analytical Testing from Experienced Industry Leaders

Nitrosamines Analysis: Solutions for Risk Management and Analytical Testing from Experienced Industry Leaders

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Overview

Given stringent regulatory guidelines regarding the presence of nitrosamines, drug innovators and manufacturers must consider control of these impurities not only in the active pharmaceutical ingredient (API) chemical process, but also in their starting materials, solvents, and more. A plan for control early in development is critical to maintaining product quality and safety. Partnering with the right CDMO can help mitigate risk throughout the process.

Key Objectives:

Definition/overview of nitrosamines
Risk assessment for the potential formation of nitrosamines
Development and validation of analytical methodology
Analytical considerations

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