Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 93906-96-8
- Technologies
Features & Benefits
Applications & Uses
- Markets
- Dosage Form
- Applications
- Solubilizer
- Carrier (vehicle)
- Penetration enhancer (dermal)
- Bio-enhancer
- Emulsifier /co-emulsifier
Properties
- Appearance
- Colorless or slightly yellow oily liquid or soft mass
- Typical Properties
- Fatty Acid Composition
- Assay
- Specifications
- Note
¹EP: European Pharmacopeia
²NF: USP/National Formulary³Compliance to EP Identification test is certified based on controls in place that assure the identity of the excipient
Value | Units | Test Method / Conditions | |
Identification Tests³ | Pass | — | — |
Peroxide Value | max. 1 | mEq/kg | NF |
Saponification Value | 245 - 272 | mg KOH/g | NF |
Value | Units | Test Method / Conditions | |
C10 | max. 10 | % | EP/NF |
C12 | max. 1.0 | % | EP/NF |
C14 | max. 0.5 | % | EP/NF |
C8 | min. 90.0 | % | EP/NF |
Value | Units | Test Method / Conditions | |
Monoacylglycerols | min. 80.0 | % | EP/NF |
Value | Units | Test Method / Conditions | |
Acid Value | max. 3.0 | mg KOH/g | ¹EP/²NF |
C6 | max. 1.0 | % | EP/NF |
Diacylglycerols | max. 20.0 | % | EP/NF |
Free Glycerol | max. 3.0 | % | EP/NF |
Total Ash | max. 0.5 | % | EP/NF |
Triacylglycerols | max. 5.0 | % | EP/NF |
Water Content | max. 1.0 | % | EP/NF |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Regulatory
- Meets the requirements of the EP/NF monographs for “Glycerol (Glyceryl) Monocaprylate” Type II.
- Mono- and diglycerides prepared from edible fats and oils or fat-forming acids are generally recognized as safe (GRAS) according to 21 CFR § 184.1505.
Packaging & Availability
- Packaging Type
- Standard Packaging
- 425 lb (192.8 kg) lined steel drum
- 50 lb (22.7 kg) HDPE container
Storage & Handling
- Shelf Life
- 24 months
- Recommended Storage and Handling
- Retest/requalify 24 months from date of manufacture.
- Store in tightly closed containers in an odor-free, dry location at ambient room temperature.
- Contents may be solid and/or liquid, and may be seasonally affected. The package must be gently warmed followed by low-shear mixing to ensure uniformity prior to use. Maximum of 6 heat cycles.