Technical Data Sheet

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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 This specification may be superseded by a later issue.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
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