Menaquinone 7 Stability of Formulations and Its Relationship with Purity Profile.

Menaquinone-7 (MK7) is a member of the vitamin K family in which interest has considerably increased over the last decade, mainly due to its beneficial role in human health. MK7 can be produced by synthesis or fermentation, and its purity profile can differ depending on methodologies and extraction procedures. Finished formulations show a high heterogeneity of purity profiles, as well as frequent discrepancies in the nominal content, compared to the actual title. The present study compared purity profiles of different raw material and related them to their stability in normal (12 months/25 °C/60%RH) and accelerated conditions (6 months/40 °C/75% RH) in order to test their performance in the presence of different common excipients. Results showed higher purity profile results in enhanced stability, and this could explain title discrepancies found in finished products, which are present on the market worldwide.