Tromethamine (Tris, THAM) is known to contain impurities than can be a potential source of Nitrosamine contamination. Pfizer and Moderna were compelled to provide Nitrosamine risk assessments for their Covid19 vaccines by the European Medicines Agency.
Known significant impurities in Tromethamine that can potentially cause health problems include:
2-amino-1,3-propanediol (APD)
2-amino-2-methyl-1,3-propanediol (AMPD)
2-(N-methylamino)-1,3-propanediol (MMAPD)
2-(N-methylamino)-2-hydroxymethyl-1,3-propanediol (MMTA)
2-(N,N-dimethylamino)-2-hydroxymethyl-1,3-propanediol (DMTA).
Various reports suggest the current detection limit for Nitrosamines in Tromethamine is 50 parts per billion (ppb).
Since secondary amines appear to be more likely to generate Nitrosamines, which are probable Human carcinogens at very low levels, can the detection level be pushed further?
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