Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 85536-01-8
- Technologies
Features & Benefits
Applications & Uses
- Markets
- Dosage Form
- Manufacturing Technology
- Pharmaceutical and Nutritional Applications
Acconon MC8-2, EP/NF is used as a solubilizer and bio-availability enhancer in oral suspensions, capsules and tablets. It can also be used as an emulsifier for microemulsions.
- Applications
- Solubilization
- Emulsification
- Encapsulation
Properties
- Physical Form
- Fatty Acid Composition
- Elemental Impurities
- Specifications
- Note
For Elemental Impurities : Data obtained for the sample was 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.
¹EP: European Pharmacopeia
²NF: United States Pharmacopeia/National Formulary
Value | Units | Test Method / Conditions | |
C10 | 20.0 - 50.0 | % | EP/NF |
C12 | max. 3.0 | % | EP/NF |
C14 | max. 1.0 | % | EP/NF |
C6 | max. 2.0 | % | ¹EP/²NF |
C8 | 50.0 - 80.0 | % | EP/NF |
Value | Units | Test Method / Conditions | |
Arsenic Content | max. 0.2 | μg/g | — |
Cadmium Content | max. 0.1 | μg/g | — |
Cobalt Content | max. 1 | μg/g | — |
Lead Content | max. 0.3 | μg/g | — |
Mercury Content | max. 0.2 | μg/g | — |
Nickel Content | max. 2 | μg/g | — |
Vanadium Content | max. 1 | μg/g | — |
Value | Units | Test Method / Conditions | |
Acid Value | max. 2.0 | mg KOH/g | ¹EP/²NF |
Alkaline impurities | Pass | — | EP |
Free Glycerol | max. 5 | % | EP/NF |
Hydroxyl Value | 170 - 205 | mg KOH/g | EP/NF |
Identification Tests | Complies | — | EP/NF |
Iodine Value | max. 2.0 | cg I2/g | EP/NF |
Peroxide Value | max. 6.0 | mEq/kg | EP/NF |
Residual Dioxane | max. 10 | ppm | EP/NF |
Residual Ethylene Oxide | max. 1 | ppm | EP/NF |
Saponification Value | 85 - 105 | mg KOH/g | EP/NF |
Total Ash | max. 0.1 | % | EP/NF |
Viscosity (at 20°C) | 80 - 110 | mPa.s | EP |
Water Content | max. 1.0 | % | EP/NF |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Regulatory
- Meets the requirements of current EP Monograph for Caprylocaproyl Macrogolglycerides.
- Meets the requirements of current NF Monograph for Caprylocaproyl Polyoxylglycerides.
Packaging & Availability
- Standard Packaging
- 450 lb (204.1 kg) drum
- 50 lb (22.7 kg) jerrican
Storage & Handling
- Shelf Life
- 24 months
- Recommended Storage and Handling
- Retest and re-qualify 24 months from the date of manufacture
- Preserve in tight containers and protect from light and moisture
- Store in a cool, dry location