Acconon® C-44 EP/NF

Identification & Functionality

Chemical Name

Glycerides C12-18

Pharma & Nutraceuticals Functions

Bioavailability Enhancer,

Carrier,

Emulsifier,

Encapsulant,

Solubilizer

CAS No.

67701-26-2

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Carriers & Bulking Agents,

Emulsifiers & Stabilizers,

Modified & Controlled Release,

Other Excipients,

Solvents & Solubilizers

Features & Benefits

Labeling Claims

Aflatoxin-free,

BSE-free,

CMR Substances-free,

Mycotoxins-free,

Non-GMO,

Polychlorinated Biphenyls (PCB)-free,

TSE-free,

Vegan

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral,

Topical,

Transdermal

Dosage Form

Capsules,

Creams,

Lotions,

Ointments,

Tablets

Manufacturing Technology

Encapsulation

Pharmaceutical and Nutritional Applications

• Solubilizer
• Bio-availability enhancer
• Emulsifier

Applications

• Solubilization
• Emulsification
• Encapsulation

Properties

Physical Form

Solid

Fatty Acid Composition

	Value	Units	Test Method / Conditions
C10	max. 12.0	%	EP/NF
C12	30.0 - 50.0	%	EP/NF
C14	5.0 - 25.0	%	EP/NF
C16	4.0 - 25.0	%	EP/NF
C18	5.0 - 35.0	%	EP/NF
C8	max. 15.0	%	¹EP/²NF

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. 0.3	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/NF
Drop Point	42.5 - 47.5	°C	EP
Free Glycerol	max. 3.0	%	EP/NF
Hydroxyl Value	36 - 56	mg KOH/g	EP/NF
Identification Tests	Complies	—	EP/NF
Iodine Value	max. 2.0	cg I2/g	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	79 - 93	mg KOH/g	EP/NF
Total Ash	max. 0.1	%	EP/NF
Water Content	max. 1.0	%	EP/NF

Note

¹EP: European Pharmacopeia
²NF: United States Pharmacopeia/National Formulary

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.

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,

National Formulary (NF),

United States Pharmacopeia (USP),

Vegan

Grade

Pharma Grade

Regulatory

• Meets the requirements of current EP Monograph for Lauroyl Macrogolglycerides
• Meets the requirements of current NF Monograph for Lauroyl Polyoxylglycerides

Packaging & Availability

Packaging Type

Drums

Standard Packaging

• 425 lb (192.8 kg) drum
• 40 lb (18.1 kg) plastic container

Storage & Handling

Shelf Life

24 months

Recommended Storage and Handling

• Retest/requalify 24 months from date manufactured
• Preserve in tight containers
• Protect from light and moisture
• Store in a cool, dry location