Sharing with you some of the recent questions at a workshop where the topic of Nitrosamine and Excipient raised to the top of the discussion. I hope to see your contribution and perspective to the questions:
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Many excipient vendors stating the absence of nitrosamines only & not mentioning about the usage of amines & nitrites. In this case how to assess risk in drug products?
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Sensitive analytical methods for N-Nitrosodialkylamine impurities by GC MS & LC MS with the specified limit of 0.03 ppm is it impossible for excipients
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Is the CPDB value and AI value the same for considering the limit for other nitrosamines?
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If the worst-case scenario is utilized, that assumes full conversion to Nitrosamines… Then where is a good starting point for Nitrate/Nitrite specification?
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With respect to process control and the potential role of process water in transferring nitrate/nitrite, is greater process water monitoring a strategy?
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IPEC tool is basically a checklist, is that enough to conduct a comprehensive risk assessment?
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how to handle the IPEC format assessment if the excipient itself is complex and made from a combination of multiple excipients(polymers, colorants)
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In the entire Supply Chain who should take the onus of quality of excipients? e,g DP mfgr or Excipient supplier