ROKwinol 20PF is a monolaurynian sorbitan ester ethoxylated by approximately 20 moles of ethylene oxide. Finally chemical parameters of ROKwinol 20PF are in line with current monograph of European Pharmacopeia for Polysorbate 20. Among others product meets strict limits for low content of ethylene oxide, dioxane or heavy metals.
Appears in the form of oily, clear liquid with yellow to light brownish color. It is characterized by very good solubility in water and polar solvents like: anhydrous ethanol, ethyl acetate or methanol. Product is practically insoluble in fatty oil and liquid paraffin.
Production of ROKwinol 20PF includes three stages where third one is the post treatment process aimed at removing undesirable by-products and contaminants.
ROKwinol 20PF is a non-ionic emulsifier for O/W type of emulsion, is applied to final drug dosage form in order to provide suitable consistency of formulation. It’s responsible for appropriate emulsification of oily additives, vitamins, active substances. Polysorbate 20 in pharmaceutical formulation is used also as binding agent, base or diluent for pills and tablets. Additionally it is used as wetting agent in flavored mount drops helping to spread other ingredients.
ROKwinol 20PF is approved by FDA as Inactive Ingredient for Approved Drug Products such as invectives, suspensions, capsules, tablets, eye/ear drops, aerosol foams, suppositories.
ROKwinol 20PF meets the requirements of the current Ph. Eur. monograph Polysorbate 20
Manufacturer: PCC Exol SA
PCC EXOL SA is one of the most important manufacturers of surfactants and chemical formulations in Central and Eastern Europe. The company offers surfactants, specialist additives and chemical formulations for many branches of industry.
All the above information related to the product are provided according to the best knowledge of the manufacturer and published in good faith. However, the manufacturer does not guarantee the information and contents of this document are complete and accurate, and shall not be liable for the results of using them. The user is obliged to verify and confirm the information and contents of this documentation on his/her own. The manufacturer reserves the right to change the content of this document at any time without stating reasons of such changes.