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The manufacturing conditions and handling of raw materials are both crucial factors for determining the quality of creatine monohydrate. Inferior raw materials or, for example, a too-rapid reduction in the amount of water during "recrystallization" results in higher values, and therefore larger amounts, of creatinine, dicyandiamide, and dihydrotriazine.
The specification of Creapure is subject to strict requirements. Creapure is tested for impurities using high pressure liquid chromatography (HPLC).
Typical analytical values for Creapure?:
Creatine monohydrate: min. 99.95%
Creatinine: < 67 ppm (below the limit of detection)
Dicyandiamide (DCD): < 30 ppm
Dihydrotriazine (DHT): not detectable
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Creapure has been studied extensively and no toxic effects were determined by any of these tests. All of the studies were carried out on Creapure? in accordance with internationally accepted guidelines and standards (FDA and EU) under GLP (Good Laboratory Practice) conditions.
Furthermore, numerous animal and human trials were commissioned to test the safety of Creapure as a supplement. In addition to the classic toxicological tests, Creapure was investigated in more than 50 clinical trials. People of all ages tested Creapure? in sports and non-sports applications over a period of more than 21 months without experiencing any side-effects.
Because other creatine manufacturers use different manufacturing processes, and therefore have different purity profiles, only Creapure has this proven safety profile.
Creatine the focus of more than 300 scientific studies is now one of the most extensively researched dietary supplements in the field of sports nutrition. Creatine supplementation has become a common practice among professional, elite, collegiate, and amateur athletes for enhancing performance.
In recent years, numerous papers have been published in professional journals and elsewhere evaluating the long-term use and clinical safety of oral creatine monohydrate supplementation using Creapure. The main focus was to evaluate if long-term Creapure supplementation (average of 5 grams/day) might increase the incidence of musculoskeletal injury, heat-related disorders (e.g., dehydration and cramping), and renal stress.
Clinical assessments included analyzing a comprehensive panel of serum and whole blood markers (electrolytes, muscle and liver enzymes, substrates, lipid profiles, red and white blood cells, etc.), renal function tests determined by creatinine clearance, monitoring of injuries treated by the medical/athletic training staff, as well as the collection of medical safety and fatigue/weakness data.
The results of these safety studies on the long-term use of Creapure have consistently shown that, in comparison to athletes who did not take creatine, those who took creatine did not experience a greater incidence of injuries, heat-related disorders (dehydration), cramping, musculoskeletal injuries, or gastrointestinal disturbances. Additionally, athletes who took creatine over a long period did not have significantly higher muscle and liver enzymes, altered electrolytes, or increased renal stress determined by creatine clearance.
Creatine is a white, flavorless, odorless fine powder. It is produced from cyanamide and sarcosinate using the cyanamide route? in a patented manufacturing process. Creatine can contain the impurities creatinine, dicyandiamide, and dihydrotriazine derivatives, and diligent checks for their presence need to be performed during the creatine manufacturing process.
All raw materials that are used to manufacture Creapure are subject to an internal rawmaterials specification. A quality control department, which is independent from the production department and has been certified according to GLP (Good Laboratory Practice), inspects the produced lots and supervises the release of the product for shipping.
Creapure has been produced in a GMP (Good Manufacturing Practice) facility since 2004. This means that Creapure is manufactured according to the same stringent requirements as those used in pharmaceutical manufacturing. Even the planning and construction of a GMP facility is subject to certain requirements and later, when the product is being produced and analyzed, special measures need to be implemented then, as well. The manufacturing process is monitored continuously, and each production step is documented in great detail. For consumers, production in a GMP facility equates to greater safety.
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