ROKAcet HR40PF produced during ethoxylation of Hydrogenated Castor Oil. Commercial form of these product contains 99% of active substance in the form of clear, yellow viscous liquid to semi – solid. Product is in line with current European Pharmacopeia Monograph for Macrogol Glycerolhydroxystearate which correspond to UPS monograph for Polyoxyl 40 Hydrogenated Castor Oil.
Thanks of post – treatment process product meets strict requirements for low limits of such contaminants as ethylene oxide, 1,4-dioxane or heavy metals which are unacceptable in pharmaceutical formulations, because of undesirable effects on active substance in final dosage forms, and toxicological effect on human health.
ROKAcet HR40PF belongs to the group of non – ionic surfactants. The HLB value for the product counts 14-16 which means that it is very good emulsifier. These property makes ROKAcet HR40PF efficient additive for emulsification of various hydrophobic API’s which improves its bioavailability. Additionally product is characterized by very good solubilizing properties used for production of aqueous solutions of vitamins A, D, E, K, essential oils or any other function ingredient of final dosage forms. It is used widely for oral and topical application because of odorless and tasteless characteristic.
Chemical equivalent of ROKAcet HR40PF is approved by FDA as Inactive Ingredient for Approved Drug Products like: emulsions, creams, oils, capsules, or dental solutions.
Biodegradable product, compliant with the biodegradability criteria set out in Regulation (EC) No. 648/2004 on detergents and Regulation No. 1223/2009 on cosmetics.
Surfactant not classified according to the CLP/GHS Regulation. Not subject to ADR/RID regulations.
meets the restricted quality parameters defined by European Pharmacopoeia for Macrogol Glycerolhydroxystearate,
low level of ethylene oxide, 1,4 – dioxane, heavy metals
excellent emulsification properties
chemical equivalent for Macrogol Glycerolhydroxystearate or Polyoxyl 40 Hydrogenated Castor Oil – substance approved by FDA as Inactive Ingredient for Approved Drug Product.
ROKAcet HR40PF meets the requirements of the current Ph.Eur. monograph Macrogolglycerol Hydroxystearate
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.
