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Acconon® MC8-2 EP/NF

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.

Brand: Acconon (30 products)

Chemical Name: Caprylocaproyl Macrogolglycerides

Functions: Bioavailability Enhancer, Co-Emulsifier, Emulsifier, Encapsulant, Solubilizer, Stabilizer, Surfactant

CAS Number: 85536-01-8

Dosage Form: Capsules, Creams, Lotions, Ointments, Tablets

Labeling Claims: Aflatoxin-free, BSE-free, CMR Substances-free, Kosher, Mycotoxins-free, Non-GMO, Polychlorinated Biphenyls (PCB)-free, TSE-free, Vegan

Certifications & Compliance: BRC Certified, European Pharmacopeia (Ph. Eur.), FDA Compliant, FDA IID, GFSI Certified, GMP, Generally Recognized As Safe (GRAS), Hazard Analysis Critical Control Point (HACCP), ISO 14001, ISO 45001, ISO 9001, Kosher, National Formulary (NF), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP), Vegan

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
Caprylocaproyl Macrogolglycerides
Pharma & Nutraceuticals Functions
Bioavailability Enhancer,
Co-Emulsifier,
Emulsifier,
Encapsulant,
Solubilizer,
Stabilizer,
Surfactant
CAS No.
85536-01-8
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Emulsifiers & Stabilizers,
Formulation & Processing Aids,
Modified & Controlled Release,
Other Excipients,
Solvents & Solubilizers

Features & Benefits

Labeling Claims
Aflatoxin-free,
BSE-free,
CMR Substances-free,
Kosher,
Mycotoxins-free,
Non-GMO,
Polychlorinated Biphenyls (PCB)-free,
TSE-free,
Vegan

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Nasal,
Oral,
Topical,
Transdermal
Dosage Form
Capsules,
Creams,
Lotions,
Ointments,
Tablets
Manufacturing Technology
Encapsulation
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

Certifications & Compliance
BRC Certified,
European Pharmacopeia (Ph. Eur.),
FDA Compliant,
FDA IID,
GFSI Certified,
GMP,
Generally Recognized As Safe (GRAS),
Hazard Analysis Critical Control Point (HACCP),
ISO 14001,
ISO 45001,
ISO 9001,
Kosher,
National Formulary (NF),
The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA),
United States Pharmacopeia (USP),
Vegan
Grade
Pharma Grade
Regulatory
  • Meets the requirements of current EP Monograph for Caprylocaproyl Macrogolglycerides.
  • Meets the requirements of current NF Monograph for Caprylocaproyl Polyoxylglycerides.

Packaging & Availability

Packaging Type
Drums,
Jerrycan
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