Creatine-HCL Stability Narrative 2017-08-16T14:30:55+00:00

CREATINE-HCL STABILITY NARRATIVE

Based on Patented “Creatine Hydrochloride”

Prepared by

Donald W. Miller, Ph.D.
Professor
Department of Pharmacology and Therapeutics
University of Manitoba

The half-life of other known forms of creatine in blood plasma is short (approximately 1-1.5 hours). Thus, to be effective, the creatine formulation must be able to reach desired blood plasma levels rapidly. In view of the bioavailability of previously known forms of creatine, such desired blood plasma levels can be obtained only by the administration of high doses of creatine, e.g., 5 to 10 g for mean body weights of about 70 kg.In contrast, the creatine HCl is able to obtain high blood plasma levels at low doses at least in part due to its increased stability. In addition, due to the overall increase in stability, the creatine HCl is capable of maintaining a minimal creatine blood serum level for longer periods of time, thereby enhancing an individual’s muscle performance.

With regard to latent product storage, standard shelf-life according to the FDA is considered to be the time it takes for 10 percent of the starting material to degrade in a given sample. Creatine monohydrate typically exhibits a shelf-life of about one week when stored in aqueous solution at room temperature. In contrast, the creatine HCl possesses a shelf-life of at least 45 days or greater in aqueous solution. In one study, the shelf-life of the creatine HCl in aqueous solution showed to be at least 60 – 75 days. In another study, the creatine HCl possessed a shelf-life of about 90 days or greater in aqueous solution. Stability may be longer but longer studies have not yet been performed.

Higher temperatures accelerate degradation of all forms of creatine, including the creatine HCl. However, when exposed to higher temperatures, creatine monohydrate still degrades at a much higher rate than creatine HCl. In one study, the shelf life of creatine HCl in aqueous solution at a temperature ranging from about 10 to 20 degrees (°C) higher than room temperature is at least about 14 – 30 days. In another test, the shelf life of the creatine HCl at 50°C is at least about 1 – 5 days. All of these results are much improved vs. creatine monohydrate.

Figure 1: Illustration of chart or graph to show some of the info in a visual.

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