ABSTRACT

The biologically active form of folate, chemically referred to as (6S)-5-methyltetrahydrofolic acid (5-MTHF) may be a superior alternative to folic acid for treating mental health disorders and improving folate levels. However, as L-5-MTHF is susceptible to thermal degradation, it is necessary to assess its stability parameters to ensure that a branded supplement is efficacious and provides the desired dosage. Three different brands of L-5-methyltetrahydrofolate specified as: Metafolin® (registered by Merck KGaA), Quatrefolic® (registered by Gnosis) and Cerebrofolate™ (registered by MTHFR Solutions, LLC) as well as a generic amorphous calcium salt form of L-5-MTHF were selected for analysis by appearance, content assay, total impurities, water content and free folate levels. USP-NF standards were followed for the various tests. The present study concluded that Metafolin® and Cerebrofolate™ exhibited superior stability and potency in comparison to the amorphous salt and glucosamine salt forms. It is imperative that manufacturers of L-5-MTHF ensure their final product meets all quality control criteria and remains therapeutically active over time. Keywords: L-methylfolate, stability, in vitro evaluation, assay, quality, Free Folate, 5-MTHF
Publication date: 15/12/2023

https://ijbpas.com/pdf/2023/December/MS_IJBPAS_2023_DECEMBER_SPCL_1066.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.12.1066