ROKAcet R36PF is an ethoxylated Castor Oil. Product is in line with current European Pharmacopeia Monograph for Macrogol Glycerol Ricinoleate which correspond to UPS monograph for Polyoxyl 35 Castor Oil.
Commercial form of product contains 99% of active substance in the form of clear, yellow viscous liquid to semi – solid. Thanks of post – treatment process product meets strict requirements for low limits of such contaminants as ethylene oxide, 1,4-dioxane or heavy metals. These impurities are unacceptable in pharmaceutical formulations, because of undesirable effects on active substance in final dosage forms, and toxicological effect on human health.
ROKAcet R36PF belongs to the group of nonionic surfactants. It is characterized by good solubilizing and emulsifying properties. In order to prepare stable final emulsion for oral, topical or parenteral application, ROKAcet R36PF is recommended to be used as solubilizer for active substances like Miconazole, Hexedatine, Clotrimazole. Product is also adequate for use as solubilizer for functional ingredients which are not soluble in water i.e. Vitamins A, D, E, K.
Chemical equivalent of ROKAcet R36PF is approved by FDA as Inactive Ingredient for Approved Drug Products like: emulsions, creams, oils, capsules and tablets. These type of substance in highly purified version is also used as a solubility enhancer for injection and infusion preparations.
meets the restricted quality parameters defined by European Pharmacopoeia for Macrogol Glycerol Ricinoleate,
low level of ethylene oxide, 1,4 – dioxane, heavy metals,
excellent emulsification properties,
chemical equivalent for Macrogol Glycerol Ricinoleate - Polyoxyl 35 Castor Oil – substance approved by FDA as Inactive Ingredient for Approved Drug Product.
ROKAcet R36PF meets the requirements of the current Ph. Eur. monograph Macrogolglycerol Ricinoleate
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.
