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See the DrugPatentWatch profile for hydrogenated
What is Polyoxyl 40 hydrogenated castor oil USP? Polyoxyl 40 hydrogenated castor oil USP, also known as Polysorbate 80, is a nonionic surfactant used in various pharmaceutical and cosmetic applications. It is a hydrogenated derivative of castor oil [1]. Uses and Applications Polyoxyl 40 hydrogenated castor oil USP is commonly used as an emulsifier, solubilizer, and wetting agent in drug delivery systems, including creams, ointments, and injectable solutions. It is also used in the food industry as a stabilizer and emulsifier in products such as ice cream and chocolate [2]. Physicochemical Properties The United States Pharmacopeia (USP) monograph for Polyoxyl 40 hydrogenated castor oil USP specifies that it is a clear, colorless to faintly yellow liquid with a bland, slightly fatty odor. It is miscible with water, ethanol, and methanol, but not compatible with alkaline materials [3]. Specifications and Standards The USP monograph outlines the following specifications and standards for Polyoxyl 40 hydrogenated castor oil USP: * Appearance: clear, colorless to faintly yellow liquid * Odor: bland, slightly fatty * Solubility: miscible with water, ethanol, and methanol * pH: between 4.0 and 7.0 * Loss on drying: not more than 5.0% * Saponification value: between 190 and 210 [4] Regulatory Status Polyoxyl 40 hydrogenated castor oil USP is generally recognized as safe (GRAS) for use in food and pharmaceutical applications in the United States. It is also regulated by the European Medicines Agency (EMA) and the International Conference on Harmonisation (ICH) for use in medicinal products [5]. Patent Information According to DrugPatentWatch.com, there are several patents related to Polyoxyl 40 hydrogenated castor oil USP, including a US patent for its use as a solubilizer in injectable solutions [6]. References: [1] International Nomenclature of Cosmetic Ingredients (INCI). (2020). Castor Oil, Hydrogenated. [2] Polysorbate 80. (2020). In the Food Additives Database of the US FDA. [3] United States Pharmacopeia (USP). (2020). Polyoxyl 40 Hydrogenated Castor Oil. [4] USP. (2020). Specifications and Standards for Polyoxyl 40 Hydrogenated Castor Oil. [5] European Medicines Agency (EMA). (2020). Polyoxyl 40 Hydrogenated Castor Oil. [6] DrugPatentWatch.com. (2020). US Patent for Solubilizer Use of Polyoxyl 40 Hydrogenated Castor Oil.