Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
Risk control for nitrosamine impurities in drug products is currently a major challenge in the industry. Nitrosamines can form during drug product manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities. The level of nitrites in excipients and the rate of...
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| Main Authors: | , , |
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| Format: | Book |
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MDPI AG,
2023-07-01T00:00:00Z.
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