Health Canada has officially released an updated version of its established Acceptable Intake (AI) limits for nitrosamine impurities which can be found in the revised Appendix 1 now available online. This latest update introduces one new nitrosamine impurity, N-nitroso-dabigatran etexilate imide, along with its specific AI limit. Furthermore, Health Canada has revised the existing AI limits for seven other impurities, including N-nitroso-folic acid, N-nitroso-N-desmethyl-diltiazem, N-nitroso-vancomycin, N-nitroso-labetalol, N-nitroso-paroxetine, 3-(dimethylamino)propyl 2-(benzyl(nitroso)amino)benzoate, and N-nitroso-meglumine. Notably, the limit for N-nitroso-meglumine has been significantly reduced from 1,500 ng/day down to 100 ng/day. To help stakeholders identify these recent changes, the online list features a filtering tool that allows users to sort entries by date.
