Technical Data Sheet 9/29/2015 ® Acconon AKG-6 EP/NF Developmental Ingredients: Oleoyl Macrogolglycerides (or Oleoyl Polyoxylglycerides) Synonyms: Apricot kernel oil PEG-6 Esters Description Specifications Oleoyl macrogolglycerides, is a mixture of monoesters, diesters and triesters of glycerol and monoesters and diesters of macrogols (polyethylene glycols (PEG) with a mean relative molecular mass of 300). It is obtained by partial alcoholysis of unsaturated oils containing mainly triglycerides of oleic (cis-9-octadecenoic) acid using macrogol (PEG) or by esterification of glycerol and macrogol (PEG) with unsaturated fatty acids or by mixture of glycerol esters and condensates of ethylene oxide with the fatty acids of these unsaturated oils. The product may contain free polyethylene glycols. Property Fatty Acid Composition (%) Specifications Specification Alkaline Impurities (0.01N HCL) Limit <1.0 mL Reference Test Method 1 <2.0 EP/NF Heavy Metals (ppm) <10 EP Free Glycerol (%) <3.0 EP/NF Hydroxyl Value (mg KOH/g) 45-65 EP/NF Iodine Value (cg I2/g) 75-95 EP/NF Peroxide Value (meq/Kg) <12.0 EP/NF 150-170 EP/NF <1.0% EP/NF <0.1 EP/NF (mg KOH/g) Water (Karl Fischer, %) Total Ash (%) Residual ethylene oxide Residual dioxane (ppm) <1 <10 C16:0 palmitic acid 4.0-9.0 C18:0 stearic acid <6.0 C18:1 oleic acid 58.0-80.0 C18:2 linoleic acid 15.0-35.0 C18:3 linolenic acid <2.0 C20:0 arachidic acid <2.0 C20:1 eicosenoic acid <2.0 Meets the requirements of current European Pharmacopoeia (EP) / United States Pharmacopeia / National Formulary (USP/NF) Monographs for Oleoyl Macrogolglycerides / Oleoyl Polyoxylglycerides. Recommended Storage and Handling Saponification Value EP/NF Regulatory EP/2NF Acid Value (mg KOH/g) Reference Method Limit Retest/requalify 24 months after manufacture. Store in tight containers, protected from light and moisture. Store at controlled room temperature. Applications Solubilizer Bio-availability enhancer EP/NF Standard Packaging 1 EP: European Pharmacopoeia USP/NF: United States Pharmacopeia/National Formulary 2 TBD DISCLAIMER: PLEASE NOTE: This specification is provided for information purposes only and should not be relied upon as a basis for product performance. It is suggested that you evaluate the product on at least a laboratory basis prior to its commercial usage. This specification may be superseded by a later issue. Please consult your sales representative to confirm that you have the correct specification. NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A SPECIFIC USE OR PURPOSE, EXPRESS OR IMPLIED, ARE MADE. These specifications are not intended to be, and shall not be construed to be, instructions or suggestions for use which may be in violation of valid patent rights. Version: 2 Preliminary Copyright © 2015 ABITEC Corporation Page 1 of 1 501 West First Avenue, Columbus, OH, USA 43215 | Toll Free: 800-555-1255 | info@abiteccorp.com | www.abiteccorp.com