Allantoin

Allantoin is a direct derivative of uric acid (2,5-dioxo-4-imidazolidinylurea) with molecular formula C4H6N4O3 and molecular weight 158.12. It is a white crystalline powder that decomposes at 225°C or above (see specifications). It occurs naturally in comfrey, sugar beet and wheat sprouts; commercial grades are produced synthetically, with assay, loss on drying and other figures listed on this page; it is a skin-conditioning ingredient common in cosmetic and topical formulations. It is soluble in hot water, hot alcohol and dilute sodium hydroxide solution, slightly soluble in water and alcohol, and practically insoluble in ether and chloroform (see specifications). Its solubility in water increases noticeably with temperature, which shapes how it is incorporated into formulations. These are factory control items; this product is not registered as a pharmaceutical excipient - suitability for pharmaceutical use is assessed by the buyer under applicable drug regulations.

Downstream applications include cosmetics, personal care and pharmaceutical uses. In cosmetics, it serves as a skin conditioner; published literature reports conditioning and moisturizing uses (finished-product efficacy is subject to the finished product's registration or filing). It is commonly used in skin creams, lotions, toners, hair conditioners, toothpaste and oral care products. In pharmaceuticals, it is a common raw material for ointment formulations; where the finished product is a drug, its indications and efficacy are defined by that product's own registration. Typical use levels in cosmetics are 0.5%-2.0%, for formulation reference; verify current requirements in your target market.

In creams, lotions, toners and hair conditioners, allantoin serves as a skin conditioner; published literature reports conditioning uses such as softening and moisturizing (finished-product efficacy is subject to the finished product's registration or filing). Its 0.5% aqueous solution shows a pH of 4.5-6.0 (see specifications), typical use levels are 0.5%-2.0% (for formulation reference; verify current requirements in your target market).

In topical formulations, allantoin is a common raw material for ointment formulations; where the finished product is a drug, its indications and efficacy are defined by that product's own registration. Formulators typically review assay (99.0-101.0), loss on drying (≤0.50%) and heavy metals (≤10 ppm) against the specifications listed on this page. Additional requirements on impurity limits can be discussed item by item during inquiry; where the downstream application is pharmaceutical, the buyer is responsible for confirming registration and compliance requirements.

In toothpaste and mouthwash formulations, allantoin serves as a conditioning ingredient, with soothing and moisturizing among its literature-reported uses (finished-product efficacy is subject to registration or filing). As it is only slightly soluble in cold water but soluble in hot water, hot processing or pre-dispersion is recommended.