Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 9011-21-6
- Technologies
Features & Benefits
Applications & Uses
- Markets
- Dosage Form
- Manufacturing Technology
- Applications
- High melt point solubilizer, bio-availability enhancer
- Solid dispersions or physical mixtures
- Surfactant
- Unique release properties based on application
- Emulsification
- Encapsulation
Properties
- Physical Form
- Typical Properties
- Fatty Acid Composition
- Specifications
- Note
¹EP: European Pharmacopeia
²USP/NF: United States Pharmacopeia/National Formulary
³Labeled Amount
Value | Units | Test Method / Conditions | |
Residual Dioxane | max. 10 | ppm | EP/NF |
Residual Ethylene Oxide | max. 1 | ppm | EP/NF |
Value | Units | Test Method / Conditions | |
C12 (Lauric Acid) | max. 5.0 | % | EP/NF |
C14 (Myristic Acid) | max. 5.0 | % | EP/NF |
C16 (Palmitic Acid) | 40.0 - 50.0 | % | NF |
C18 (Stearic Acid) | 48.0 - 58.0 | % | NF |
Total Stearic Palmitic combined | min. 90.0 | % | EP |
Value | Units | Test Method / Conditions | |
Acid Value | max. 2.0 | mg KOH/g | EP/NF |
Alkaline Impurities (0.01N HCL) | max. 1.0 | mL | ¹EP/²NF |
Free Glycerol | max. 3.0 | % | EP/NF |
Hydroxyl Value | 25 - 56 | mg KOH/g | EP/NF |
Hydroxyl Value | 85 - 115 | mg KOH/g (% la³) | EP/NF |
Iodine Value | max. 2.0 | cg I2/g | NF |
Peroxide Value | max. 6.0 | meq O2/kg | EP/NF |
Saponification Value | 67 - 112 | mg KOH/g | EP/NF |
Saponification Value | 90 - 110 | mg KOH/g (% la³) | EP/NF |
Total Ash | max. 0.2 | % | EP/NF |
Water Content | max. 1.0 | % | EP/NF (Karl Fischer) |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Regulatory
Meets the requirements of current European Pharmacopeia (EP) and United States Pharmacopeia/National Formulary (USP/NF) Monographs for Stearoyl Macrogolglycerides / Stearoyl Polyoxylglycerides.
Packaging & Availability
- Packaging Type
- Standard Packaging
- 425 lb (192.8 kg) drum
- 40 lb (18.1 kg) HDPE
Storage & Handling
- Shelf Life
- 24 months
- Recommended Storage and Handling
- Retest/requalify 24 months after manufacture
- Store in a cool dry location. Preserve in tight containers and protect from light and moisture