Captex® 300 EP/NF

1 of 28 products in this brand
Captex® 300 EP/NF is manufactured by the esterification of glycerin and fatty acids, mainly caprylic (‰ˆ70%) 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.

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

Technical Data Sheet

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Identification & Functionality

Chemical Family

Features & Benefits

Applications & Uses

Applications
  • Carrier (vehicle)
  • Solubilizer
  • Lubricant (soft gel caps)
  • Emollient (topical)
  • Viscosity modifier
  • Energy source

Properties

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

Regulatory

Meets current European Pharmacopeia and National Formulary Monographs for Medium-Chain Triglycerides.

Safety & Health

Product Stewardship

ABITEC’s product 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
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.