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Captex® 355 EP/NF

Captex® 355 EP/NF is manufactured by the esterification of glycerin and fatty acids, mainly caprylic (‰ˆ55%) 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: Captex (28 products)

Functions: Carrier, Emollient, Lubricant, Solubilizer, Solvent, Viscosity Modifier

Dosage Form: Capsules, Emulsions, Soft Gels, Suspension

Labeling Claims: Aflatoxin-free, Allergen-free, BSE-free, CMR Substances-free, Kosher, Mycotoxins-free, Naturally Derived, 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, Kosher, National Formulary (NF), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP), Vegan

Technical Data Sheet

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
Carrier,
Emollient,
Lubricant,
Solubilizer,
Solvent,
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,
Naturally Derived,
Non-GMO,
Polychlorinated Biphenyls (PCB)-free,
TSE-free,
Vegan

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Nasal,
Oral,
Topical
Dosage Form
Capsules,
Emulsions,
Soft Gels,
Suspension
Applications
  • Carrier (vehicle)
  • Solubilizer
  • Lubricant (soft gel caps)
  • Emollient (topical)
  • Viscosity modifier
  • Energy source

Properties

Physical Form
Liquid
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
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 - 0.96-NF
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

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,
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.

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.