Acconon® MC8-2 EP/NF is a mixture of monoesters, diesters, and triesters of glycerol and monoesters and diesters of polyethylene glycols with a mean relative molecular weight between 200-400. It may contain free macrogols. It is manufactured in USA.
Chemical Name: Caprylocaproyl Macrogolglycerides
Function: Surfactant, Stabilizer, Solubilizer, Encapsulant, Emulsifier, Co-Emulsifier, Bioavailability Enhancer
CAS Number: 85536-01-8
Dosage Form: Creams, Ointments, Capsules, Lotions, Tablets
Labeling Claims: Kosher, BSE-free, Vegan, Polychlorinated Biphenyls (PCB)-free, Aflatoxin-free, TSE-free, Non-GMO, CMR Substances-free, Mycotoxins-free
Certifications & Compliance: FDA Approved, GFSI Certified, United States Pharmacopeia (USP), ISO 14001, European Pharmacopeia (Ph. Eur.), Vegan, ISO 9001, FDA IID, ISO 45001, Kosher, The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), National Formulary (NF), BRC Certified, Generally Recognized As Safe (GRAS), Hazard Analysis Critical Control Point (HACCP), GMP
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Acconon® MC8-2 EP-NF Elemental Impurities
Acconon® MC8-2 EP-NF Elemental Impurities
OtherKnowde Enhanced TDS
Identification & Functionality
Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
Technologies
Acconon® MC8-2 EP/NF Features & Benefits
Applications & Uses
Markets
Dosage Form
Manufacturing Technology
Pharmaceutical and Nutritional Applications
Acconon MC8-2, EP/NF is used as a solubilizer and bio-availability enhancer in oral suspensions, capsules and tablets. It can also be used as an emulsifier for microemulsions.
Applications
- Solubilization
- Emulsification
- Encapsulation
Properties
Physical Form
Fatty Acid Composition
| Value | Units | Test Method / Conditions | |
| C10 | 20.0 - 50.0 | % | EP/NF |
| C12 | max. 3.0 | % | EP/NF |
| C14 | max. 1.0 | % | EP/NF |
| C6 | max. 2.0 | % | ¹EP/²NF |
| C8 | 50.0 - 80.0 | % | EP/NF |
Elemental Impurities
| Value | Units | Test Method / Conditions | |
| Arsenic Content | max. 0.2 | μg/g | - |
| Cadmium Content | max. 0.1 | μg/g | - |
| Cobalt Content | max. 1 | μg/g | - |
| Lead Content | max. 0.3 | μg/g | - |
| Mercury Content | max. 0.2 | μg/g | - |
| Nickel Content | max. 2 | μg/g | - |
| Vanadium Content | max. 1 | μg/g | - |
Specifications
| Value | Units | Test Method / Conditions | |
| Acid Value | max. 2.0 | mg KOH/g | ¹EP/²NF |
| Alkaline impurities | Pass | - | EP |
| Free Glycerol | max. 5 | % | EP/NF |
| Hydroxyl Value | 170 - 205 | mg KOH/g | EP/NF |
| Identification Tests | Complies | - | EP/NF |
| Iodine Value | max. 2.0 | cg I2/g | EP/NF |
| Peroxide Value | max. 6.0 | mEq/kg | EP/NF |
| Residual Dioxane | max. 10 | ppm | EP/NF |
| Residual Ethylene Oxide | max. 1 | ppm | EP/NF |
| Saponification Value | 85 - 105 | mg KOH/g | EP/NF |
| Total Ash | max. 0.1 | % | EP/NF |
| Viscosity (at 20°C) | 80 - 110 | mPa.s | EP |
| Water Content | max. 1.0 | % | EP/NF |
Note
For Elemental Impurities : Data obtained for the sample was below the listed initial-results ranges levels. Initial-results ranges data are for informational purposes only and do not constitute specifications. Testing is expected to continue on a periodic basis for the material, however, the frequency is to be determined.
¹EP: European Pharmacopeia
²NF: United States Pharmacopeia/National Formulary
Regulatory & Compliance
Certifications & Compliance
Grade
Regulatory
- Meets the requirements of current EP Monograph for Caprylocaproyl Macrogolglycerides.
- Meets the requirements of current NF Monograph for Caprylocaproyl Polyoxylglycerides.
Packaging & Availability
Storage & Handling
Shelf Life
Recommended Storage and Handling
- Retest and re-qualify 24 months from the date of manufacture
- Preserve in tight containers and protect from light and moisture
- Store in a cool, dry location
Acconon® MC8-2 EP/NF
ABITEC Corporation