Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Ingredient Origin
- Pharma & Nutraceuticals Functions
- Technologies
Features & Benefits
Applications & Uses
- Markets
- 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
- Elemental Impurities
- Specifications
- 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.
| 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 |
| 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 | — |
| 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 |
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.