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In September 2023, the FDA placed it in Category 2 of its interim 503A bulks list: the list of substances flagged for significant safety concerns that could not be used by compounding pharmacies

After preincubation, the samples were placed on ice and other components were added to the mixture: 4 L 5 concentrated RT buffer (250 mM Tris-HCl, 250 mM KCl, 20 mM MgCl 2 , 50 mM DTT, pH 8.3 at 25 C), 2 L deoxyribonucleotide triphosphates (dNTPs, 10 mM) and 1 L RNase inhibitor (20 U/L) and 1 L GoScriptTM Reverse Transcriptase (160 U/L) in a total volume of 20 L

But its not without risks, especially the TMAO connection, which may raise long-term concerns about artery health