Excipient & Nitrosamines -Q&A session

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:

  1. 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?

  2. 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

  3. Is the CPDB value and AI value the same for considering the limit for other nitrosamines?

  4. If the worst-case scenario is utilized, that assumes full conversion to Nitrosamines… Then where is a good starting point for Nitrate/Nitrite specification?

  5. With respect to process control and the potential role of process water in transferring nitrate/nitrite, is greater process water monitoring a strategy?

  6. IPEC tool is basically a checklist, is that enough to conduct a comprehensive risk assessment?

  7. how to handle the IPEC format assessment if the excipient itself is complex and made from a combination of multiple excipients(polymers, colorants)

  8. In the entire Supply Chain who should take the onus of quality of excipients? e,g DP mfgr or Excipient supplier