Creatine monohydrate

Grades and forms of creatine monohydrate

Creatine monohydrate is the creatine form supplement manufacturers most often buy in bulk. It is a white crystalline powder carrying one molecule of water of crystallisation per molecule of creatine, with a molar mass of 149.15 g/mol. SoleChem supplies it to EU manufacturers under ISO 22000 certified operations.

Commercial creatine monohydrate powder differs mainly in particle size. Standard material suits capsules and tablets, where flow and fill weight matter more than dispersion. Micronised material has finer particles, disperses faster in water and shakes, and leaves less grit in the glass.

Purity is the other buying criterion. Creatine is made by chemical synthesis, so buyers check limits for by-products such as creatinine, dicyandiamide and dihydrotriazine. The specification sheet states the particle size distribution, assay, loss on drying and impurity limits for each grade. Ask for the grade you need in the quote form.

EU regulatory status

Creatine is neither a vitamin nor a mineral, so it is not listed in Annex II of Directive 2002/46/EC. In food supplements it counts as a substance with a nutritional or physiological effect. The Directive sets no harmonised list or maximum amounts for such substances.

Member states therefore apply national rules to creatine in food supplements. These rules may set maximum amounts per daily portion or require specific warnings, or may contain no specific provision. Member states may also require notification of the placing of a food supplement on the market, a procedure Article 10 of the Directive allows. Check each target market separately.

Regulation (EC) No 1925/2006 lets the Commission restrict or prohibit other substances added to foods through its Annex III. Confirm that creatine has no entry there before formulating fortified foods or supplements. Novel-food status under Regulation (EU) 2015/2283 must also be confirmed for your product category; see the novel food guide.

Claims for creatine fall under Regulation (EC) No 1924/2006. Take any wording and its conditions of use from the EU Register of nutrition and health claims, and read the health-claims guide.

Formulation notes

Solubility. Creatine monohydrate has limited water solubility at room temperature and dissolves more readily in warm water. Most products are designed to disperse rather than dissolve, which is why micronised grades dominate powders and sports nutrition. It is often combined with beta-alanine, L-citrulline, taurine and L-leucine in multi-ingredient powders.

Stability in water. The dry powder is stable under normal storage. In aqueous solution, creatine slowly cyclises to creatinine, and the reaction runs faster at low pH and higher temperature. Ready-to-drink liquids and acidic gummies need stability testing over the intended shelf life. The overage calculator helps where losses are measured.

Capsules and tablets. Creatine products usually declare gram quantities per serving, so capsule and tablet products need several units per serving. Flow aids such as silicon dioxide help keep fill weights even, and vegetarian shells are typically HPMC. Tablets usually need binders; run compression trials on the grade you intend to buy.

Taste and handling. The material is close to neutral in taste. Mouthfeel complaints usually come from undissolved particles, which a finer grade reduces.

Label arithmetic. Article 8 of Directive 2002/46/EC requires the amount of each substance with a nutritional or physiological effect to be declared numerically per daily portion. Decide first whether the label states creatine monohydrate or creatine. If it states creatine monohydrate, the powder mass equals the claim, plus any overage. If it states creatine, divide the claim by the creatine fraction, which is the molar mass of anhydrous creatine divided by 149.15. Check whether the certificate of analysis reports assay as-is or on an anhydrous basis, since loss on drying reflects the water of crystallisation. Labelling rules in Regulation (EU) No 1169/2011 also apply; see the labelling guide.