Good Read ... on N-nitrosamine Limits

Interesting read from Bercu et all.

Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N -Nitrosodiethylamine (NDEA)


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We have in the community key contributors to this publication @jbercu @fernandaw. I was wondering if you can help us understand how the whole framework presented in the paper can fit or be built in the overall risk assessment or control strategy of Nitrosamine. Thx

The paper basically shows that using NDEA as an example, the LTL limits described in ICH M7 are appropriate and conservative enough for nitrosamines also. This means we can adapt the limits based on duration of exposure, just like the staged-TTC described in M7. However for nitrosamines we would need to multiply the acceptable limit by corresponding factors. Anvisa’s guidance for nitrosamines already describes this as a permitted approach.