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Capmul® GDB EP/NF

Capmul® GDB EP/NF is a mixture of diglycerides, mainly glyceryl dibehenate, together with variable quantities of monoglycerides and triglycerides. It is obtained by the esterification of glycerol with behenic acid of vegetable origin. It is manufactured in USA.

Brand: Capmul (31 products)

Chemical Name: Glyceryl Dibehenate

CAS Number: 94201-62-4

Functions: Binder, Bioavailability Enhancer, Carrier, Controlled Release Agent, Diluent, Lubricant, Solubilizer, Sustained Release Agent, Thickener, Viscosity Modifier

Dosage Form: Capsules, Tablets

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

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

Synonyms: 1,1′-(2-Hydroxy-1,3-propanediyl) didocosanoate, 1,3-Dibehenin, 2-Hydroxypropane-1,3-diyl didocosanoate

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

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
ValueUnitsTest Method / Conditions
Melting Point65 - 77°C-
Fatty Acid Composition
ValueUnitsTest Method / Conditions
C16:0max. 3.0%EP / NF
C18:0max. 5.0%EP / NF
C20:0max. 10%EP / NF
C22:0min. 83.0%EP / NF
C22:1max. 3.0%EP / NF
C24:0max. 3.0%EP / NF
Assay
ValueUnitsTest Method / Conditions
Monoacylglycerols15.0 - 23.0%EP / NF
Elemental Impurities
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 0.2μg/g-
Cadmium Contentmax. 0.2μg/g-
Cobalt Contentmax. 1μg/g-
Lead Contentmax. 0.2μg/g-
Mercury Contentmax. 0.2μg/g-
Nickel Contentmax. 1μg/g-
Nickel Contentmax. 1ppm-
Vanadium Contentmax. 1μg/g-
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 4.0mg KOH/g¹EP/²NF
Diacylglycerols40.0 - 60.0%EP/NF
Free Glycerolmax. 1.0%EP / NF
Iodine Valuemax. 3.0cg I2/gEP
Saponification Value145 - 165mg KOH/gEP
Total Ash / Residue on Ignitionmax. 0.1%EP / NF
Triacylglycerols21.0 - 35.0%EP / NF
Water Contentmax. 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.