Acconon® MC8-2 EP/NF

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

	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

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