NITROSAMINES RISK MITIGATION

By DFE Pharma

Nitrosamines risk mitigation: One of the potential risk factors to take into consideration during the drug product risk assessment are the excipients. Even if the risk of the presence of nitrosamines is very low, many excipients do contain traces of nitrites that can, under specific conditions, ultimately result in formation of nitrosamines within the drug product.

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