1,3-Propanediol, 2-amino-2-(hydroxymethyl)-, hydrochloride (1:1);
2-Amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride. [1185-53-1]
BRIEFING
Tromethamine Hydrochloride. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed.
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The HPLC-RI method in the Assay is based on analyses performed with the Supelco Supelcosil LC NH2 brand of column with L8 packing. The typical retention time for tromethamine is about 3.4 min.
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The HPLC-ELSD method in the test for Organic Impurities is based on analyses performed with the Waters XBridge BEH Amide, 130 Å, brand of column with L68 packing. The typical retention times for tris(hydroxymethyl)nitromethane, Diluent peak, hydrochloride, and tromethamine are about 1.7, 2.4, 3.5, and 10.5 min, respectively.
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In the Limit of Nitromethane test, the headspace GC-FID method is based on analyses performed with the Phenomenex ZB-624 brand of column with G43 phase. The typical retention times for methanol, ethanol, and nitromethane are about 2.5, 3.4, and 6.7 min, respectively.
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In the Limit of Polyoxymethylene Dimethyl Ether test, the headspace GC-FID method is based on analyses performed with the Phenomenex ZB-Waxplus brand of column with G16 phase. The typical retention time for diethoxymethane is about 6.5 min.
(SE: S. Saladi)
Case ID—SUB-1641