N-nitroso-Impurity C in Metamizol Drug product

Limits of Nitrosamines
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Hello dear Community
it is a pleasure to join such an amazing group

Recently we found an FDA workshop conducted back in 2021, titled : Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation.
The attached is one of the pages as shared

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We cant find the exact literature reference given (Berscheid et al 1978) concluding that N-nitroso-impurity C in metamizole is not carcinogenic. Your help would be much appreciated.

Best regards
Eleni

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I believe this is the reference you are looking for:
https://onlinelibrary.wiley.com/doi/10.1002/anie.197803672

1 Like
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I have found this article which seems to be relevant:
https://bpspubs.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/j.1365-2125.1980.tb01815.x

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It is citing

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2 Likes
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Dear Naiffer

thank you for your kind input.

please note that I have also found this link, but no access is permitted right now.

[The Potential carcinogenicity of nitrosatable drugs : WHO symposium, Geneva, June 1978 - NLM Catalog - NCBI (nih.gov)] The Potential carcinogenicity of nitrosatable drugs : WHO symposium, Geneva, June 1978 - NLM Catalog - NCBI

Do you have the exact paper?

Thank you

5

Thank you very much

I trust the original paper can be found here

[The Potential carcinogenicity of nitrosatable drugs : WHO symposium, Geneva, June 1978 - NLM Catalog - NCBI (nih.gov)] The Potential carcinogenicity of nitrosatable drugs : WHO symposium, Geneva, June 1978 - NLM Catalog - NCBI

Best regards