Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- Ingredient Origin
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
Applications & Uses
- Markets
- Applications
- Dosage Form
- Pharmaceutical and Nutritional Applications
- Carrier (vehicle)
- Solubilizer
- Lubricant (soft gelatin capsules)
- Energy source
- Emollient (topical)
- Viscosity modifier
- Applications
Solubilization
Properties
- Physical Form
- Fatty Acid Composition
Value Units Test Method / Conditions C10 20.0 - 50.0 % EP/NF C12 max. 3.0 % EP/NF C14 max. 1.0 % EP/NF C16 max. 1.0 % EP C6 max. 2.0 % ¹EP/²NF C8 50.0 - 80.0 % EP/NF - Elemental Impurities
Value Units Test Method / Conditions Arsenic Content max. 1 μg/g - Cadmium Content max. 0.1 μg/g - Cobalt Content max. 1 μg/g - Lead Content max. 0.1 μg/g - Mercury Content max. 0.3 μg/g - Nickel Content max. 1 μg/g - Vanadium Content max. 1 μg/g - - Specifications
Value Units Test Method / Conditions Acid Value max. 0.2 mg KOH/g ¹EP/²NF Acid Value max. 0.5 mg KOH/g JPE Alkaline impurities Pass - EP/NF Hydroxyl Value max. 10 mg KOH/g EP/NF Hydroxyl Value max. 10 mg KOH/g JPE Identification tests Pass - JPE Iodine Value max. 1 cg I2/g NF Iodine Value max. 1 cg I2/g JPE Peroxide Value max. 1.0 mEq/kg EP/NF Purity (Alkali) Pass - JPE Purity (Arsenic) max. 2 ppm JPE Purity (Heavy metals) max. 10 ppm JPE Residue on Ignition max. 0.10 % JPE Saponification Value 320 - 385 mg KOH/g JPE Specific Gravity (at 20°C) 0.93 - 0.96 - NF Sulfated Ash max. 0.1 % EP Total Ash max. 0.1 % NF Unsaponifiable Matter max. 1.0 % JPE Viscosity (at 20°C) 25 - 33 mPa.s EP/NF Water Content max. 0.2 % EP/NF Water Content max. 0.20 % JPE - Note
1EP: European Pharmacopeia
2NF: USP/National Formulary
3JPE: Japanese Pharmaceutical Excipients
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
- Grade
- Regulatory
Meets current European Pharmacopeia for Triglycerides, Medium-Chain, United States Pharmacopeia/National Formulary for Medium-Chain Triglyerides and Japanese Pharmaceutical Excipients monographs for Medium Chain (Fatty Acid) 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
- 2550 lb (1157 kg) tote
- 425 lb (192.8 kg) drum
- 50 lb (22.7 kg) pail
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.