Capmul® GDB EP/NF

Identification & Functionality

Chemical Name

Glyceryl Dibehenate

Pharma & Nutraceuticals Functions

Binder,

Bioavailability Enhancer,

Carrier,

Controlled Release Agent,

Diluent,

Lubricant,

Solubilizer,

Sustained Release Agent,

Thickener,

Viscosity Modifier

CAS No.

94201-62-4

EC No.

303-650-6

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Base Fluids, Glidants & Lubricants,

Binders & Disintegrants,

Carriers & Bulking Agents,

Fillers & Diluents,

Formulation & Processing Aids,

Modified & Controlled Release,

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

Dosage Form

Capsules,

Tablets

Manufacturing Technology

Direct Compression

Applications

• Lubricant for tablets and capsules
• Inert lipid matrix for sustained release
• Formulation aid

Properties

Physical Form

Powder,

Solid

Appearance

White to off-white powder

Typical Properties

	Value	Units	Test Method / Conditions
Melting Point	65 - 77	°C	—

Fatty Acid Composition

	Value	Units	Test Method / Conditions
C16:0	max. 3.0	%	EP / NF
C18:0	max. 5.0	%	EP / NF
C20:0	max. 10	%	EP / NF
C22:0	min. 83.0	%	EP / NF
C22:1	max. 3.0	%	EP / NF
C24:0	max. 3.0	%	EP / NF

Assay

	Value	Units	Test Method / Conditions
Monoacylglycerols	15.0 - 23.0	%	EP / NF

Elemental Impurities

	Value	Units	Test Method / Conditions
Arsenic Content	max. 0.2	μg/g	—
Cadmium Content	max. 0.2	μg/g	—
Cobalt Content	max. 1	μg/g	—
Lead Content	max. 0.2	μg/g	—
Mercury Content	max. 0.2	μg/g	—
Nickel Content	max. 1	μg/g	—
Nickel Content	max. 1	ppm	—
Vanadium Content	max. 1	μg/g	—

Specifications

	Value	Units	Test Method / Conditions
Acid Value	max. 4.0	mg KOH/g	¹EP/²NF
Diacylglycerols	40.0 - 60.0	%	EP/NF
Free Glycerol	max. 1.0	%	EP / NF
Iodine Value	max. 3.0	cg I2/g	EP
Saponification Value	145 - 165	mg KOH/g	EP
Total Ash / Residue on Ignition	max. 0.1	%	EP / NF
Triacylglycerols	21.0 - 35.0	%	EP / NF
Water Content	max. 1.0	%	EP / NF

Note

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

For Elemental Impurities :Data obtained for the samples were 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,

GFSI Certified,

GMP,

Generally Recognized As Safe (GRAS),

Hazard Analysis Critical Control Point (HACCP),

ISO 14001,

ISO 45001,

ISO 9001,

National Formulary (NF),

The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA),

United States Pharmacopeia (USP),

Vegan

Grade

Pharma Grade

Regulatory

• Complies with the United States Pharmacopeia / National Formulary monograph for Glyceryl dibehenate.
• Complies with the European Pharmacopeia monograph for Glycerol dibehenate).

Packaging & Availability

Packaging Type

Drums

Standard Packaging

• 25 kg HDPE drum

Storage & Handling

Recommended Storage and Handling

• Retest/requalify 36 months from date of manufacture.
• Store in tightly closed containers below 35°C.