Anybody inquired about Ramipril, Benzapril, Quinapril?

We have had several ongoing discussions within the community regarding N-nitroso-Quinapril, and the Prils (ACE Inhibitors) class.
I recently participated in USP’s Nitrosamine Workshop (India) and received several inquiries about Ramipril, Benzapril, and Quinapril… Is anybody receiving questions from regulatory agencies about these products? Any agreement on the limits?

Class features:

  • benazepril (Lotensin, Lotensin Hct), - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
  • captopril (Capoten) – No secondary amine, hence not possible.
  • enalapril (Vasotec), - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
  • fosinopril (Monopril) – No Secondary amine, hence no possibility.
  • lisinopril (Prinivil, Zestril) - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
  • moexipril (Univasc) - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
  • perindopril (Aceon) - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative
  • quinapril (Accupril), - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
  • ramipril (Altace), - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.
  • trandolapril (Mavik) - Secondary amine is present. Hence there is a possibility of formation of Nitrosamine derivative.

Summary of community discussions: