MHRA today published the guideline on Nitrosamines Impurities
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Can any one idea about possibility of Nitrosamine Impurities from Chloramine.
MHRA has published: To check “Chloramine consideration in risk assessments”.
For details about “possibility of Nitrosamine Impurities from Chloramine” please refer below article
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Hats off to Yosuke and Lucas for their impressive work on the CPCA calculation tool! Your dedication and initiative are highly appreciated in simplifying this process for the Nitrosamine Exchange community. Kudos!
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Regarding the vulnerability of different structures to form nitrosamines in contact with water disinfected by chlorination, you can also check out
https://www.sciencedirect.com/science/article/abs/pii/S0043135410006913?via%3Dihub
and
https://www.sciencedirect.com/science/article/abs/pii/S0045653520331192
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Last Thursday, the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) published a new webpage that provides a high-level overview of the agency’s approach to nitrosamines impurities. On a single website without a detailed test and with few links to more information, the regulator touches on topics ranging from international harmonization to common pitfalls when sponsors submit required nitrosamine information on how to handle product batches that fall above or below AI limits. While the guideline notes that the agency will generally use the ICH M7 guideline, as well as E.U. guidelines, they may also conduct a national assessment (and notify manufacturers) before making any decisions on these regulations.
Overall, this update adds very little to the already available guidelines. It provides information on the temporary use of nitrosamines exceeding AIs. It notes the need to contact the Defective Medicines Report Center. Still, the MHRA remains silent on NDSRIs and how they would be tackled from the regulatory perspective, aside from referring to ICH and EMA guidelines. Additional details are likely forthcoming.
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