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Acconon® MC8-2 EP/NF

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Chemical Name: Caprylocaproyl Macrogolglycerides
Function: Surfactant, Stabilizer, Emulsifier, Co-Emulsifier, Bioavailability Enhancer, Solubilizer, Encapsulant
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: Hazard Analysis Critical Control Point (HACCP), GMP, 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)
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Knowde Enhanced TDS

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Identification & Functionality

Acconon® MC8-2 EP/NF Features & Benefits

Applications & Uses

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
Liquid
Fatty Acid Composition
ValueUnitsTest Method / Conditions
C1020.0 - 50.0%EP/NF
C12max. 3.0%EP/NF
C14max. 1.0%EP/NF
C6max. 2.0%¹EP/²NF
C850.0 - 80.0%EP/NF
Elemental Impurities
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 0.2μg/g-
Cadmium Contentmax. 0.1μg/g-
Cobalt Contentmax. 1μg/g-
Lead Contentmax. 0.3μg/g-
Mercury Contentmax. 0.2μg/g-
Nickel Contentmax. 2μg/g-
Vanadium Contentmax. 1μg/g-
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 2.0mg KOH/g¹EP/²NF
Alkaline impuritiesPass-EP
Free Glycerolmax. 5%EP/NF
Hydroxyl Value170 - 205mg KOH/gEP/NF
Identification TestsComplies-EP/NF
Iodine Valuemax. 2.0cg I2/gEP/NF
Peroxide Valuemax. 6.0mEq/kgEP/NF
Residual Dioxanemax. 10ppmEP/NF
Residual Ethylene Oxidemax. 1ppmEP/NF
Saponification Value85 - 105mg KOH/gEP/NF
Total Ashmax. 0.1%EP/NF
Viscosity (at 20°C)80 - 110mPa.sEP
Water Contentmax. 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

Packaging & Availability

Packaging Type
Standard Packaging
  • 450 lb (204.1 kg) drum
  • 50 lb (22.7 kg) jerrican

Storage & Handling

Shelf Life
24 months
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