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Excipient MultiFunctional B

Excipient MultiFunctional B is manufactured by the esterification of glycerin and fatty acids, mainly caprylic (°70%) and capric. It contains not less than 95% of saturated fatty acids with 8 and 10 carbon atoms. It is prepared from raw materials of vegetable sources. It is miscible with most organic solvents including 96% ethanol. It is manufactured in USA.

Brand: Excipient (4 products)

Functions: Bioavailability Enhancer, Carrier, Emollient, Lubricant, Solubilizer, Viscosity Modifier

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

Labeling Claims: Aflatoxin-free, Allergen-free, BSE-free, CMR Substances-free, Kosher, Mycotoxins-free, Natural, Naturally Derived, Non-GMO, Plant-Based, 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

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Family
Triglycerides
Ingredient Origin
Natural Origin,
Non-Animal Origin,
Plant Origin,
Vegetable Origin
Pharma & Nutraceuticals Functions
Bioavailability Enhancer,
Carrier,
Emollient,
Lubricant,
Solubilizer,
Viscosity Modifier
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Base Fluids, Glidants & Lubricants,
Carriers & Bulking Agents,
Formulation & Processing Aids,
Solvents & Solubilizers

Features & Benefits

Labeling Claims
Aflatoxin-free,
Allergen-free,
BSE-free,
CMR Substances-free,
Kosher,
Mycotoxins-free,
Natural,
Naturally Derived,
Non-GMO,
Plant-Based,
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
Applications
  • Carrier (vehicle)
  • Solubilizer
  • Lubricant (soft gel caps)
  • Emollient (topical)
  • Viscosity modifier
  • Energy source

Properties

Physical Form
Liquid
Fatty Acid Composition
ValueUnitsTest Method / Conditions
C850.0 - 80.0%EP/NF
C6max. 2.0%¹EP/²NF
C16max. 1.0%EP
C14max. 1.0%EP/NF
C12max. 3.0%EP/NF
C1020.0 - 50.0%EP/NF
Elemental Impurities
ValueUnitsTest Method / Conditions
Vanadium Contentmax. 1μg/g-
Nickel Contentmax. 1μg/g-
Mercury Contentmax. 0.3μg/g-
Lead Contentmax. 0.1μg/g-
Cobalt Contentmax. 1μg/g-
Cadmium Contentmax. 0.1μg/g-
Arsenic Contentmax. 1μg/g-
Specifications
ValueUnitsTest Method / Conditions
Water Contentmax. 0.2%EP/NF
Viscosity25 - 33mPa.sEP/NF
Total Ashmax. 0.1%NF
Sulfated Ashmax. 0.1%EP
Specific Gravity (at 20°C)0.93 - 0.96-NF
Peroxide Valuemax. 1.0mEq/kgEP/NF
Iodine Valuemax. 1cg I2/gNF
Hydroxyl Valuemax. 10mg KOH/gEP/NF
Alkaline impurities (0.01N NaOH)max. 0.15mLEP/NF
Acid Valuemax. 0.2mg KOH/g¹EP/²NF
Note

1EP: European Pharmacopeia
2NF: 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,
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 current European Pharmacopeia and National Formulary Monographs for Medium-Chain Triglycerides.

Safety & Health

Product Stewardship

Excipient MultiFunctional B stewardship rests with all individuals involved with the products, from the initial concept and research, to manufacture, testing, use, sale, storage, distribution and disposition of each product. Each individual takes the appropriate steps to protect employee health, public health and the environment.

Packaging & Availability

Packaging Type
Drums,
Jerrycan
Standard Packaging
  • 425 lb (192.8 kg) drum
  • 50 lb (22.7 kg) HDPE jerrican

Storage & Handling

Shelf Life
36 months
Recommended Storage and Handling
  • Store in tightly-sealed containers in a dry location at ambient temperature, protected from light.
  • Retest/requalify 36 months after date of manufacture.