Capmul® MCM C8 EP/NF is a mixture of monoacylglycerols, containing variable quantities of diand tri-acylglycerols, obtained by direct esterification of glycerol with caprylic (octanoic) acid. It is manufactured in USA.
Chemical Name: Glyceryl Monocaprylate
Function: Solubilizer, Penetration Enhancer, Emulsifier, Bioavailability Enhancer
CAS Number: 93906-96-8
Dosage Form: Creams, Ointments, Capsules, Lotions, Tablets
Labeling Claims: BSE-free, Vegan, Polychlorinated Biphenyls (PCB)-free, Aflatoxin-free, TSE-free, Non-GMO, CMR Substances-free, Allergen-free, Mycotoxins-free
Certifications & Compliance: FDA Approved, GFSI Certified, United States Pharmacopeia (USP), ISO 14001, European Pharmacopeia (Ph. Eur.), Vegan, ISO 9001, FDA IID, ISO 45001, The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), National Formulary (NF), BRC Certified, Generally Recognized As Safe (GRAS), Hazard Analysis Critical Control Point (HACCP), GMP
Synonyms: Ethoxylated sorbitan monostearate, PEG sorbitan monostearate, POE sorbitan monostearate, Poly(oxyethylene) sorbitol monostearate, Poly(oxyethylene)sorbitan monostearate, Polyethylene glycol sorbitan monostearate, Polyethylene glycol sorbitan monostearate ether, Polyethylene sorbitan monostearate, Polyoxyethylene sorbitan ether monostearate, Polyoxyethylene sorbitan monooctadecanoate, Polyoxyethylene sorbitan monostearate, Polyoxyethylene sorbitan monostearic acid ester, Polyoxyethylene sorbitan stearate, Propoxylated sorbitol monostearate, Sorbitan monostearate polyethylene glycol ether, Sorbitan monostearate polyoxyethylene ether, Sorbitan polyethoxy monostearate
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Abitec Pharma Brochure 2021
BrochureTechnical Data Sheet
Capmul® MCM C8 EP/NF Technical Data Sheet
Capmul® MCM C8 EP/NF Technical Data Sheet
Technical Data SheetBrochure
Lipid Excipient Portfolio
Lipid Excipient Portfolio
BrochureOther
Capmul® Excipients Guidance for Storage and Handling
Capmul® Excipients Guidance for Storage and Handling
OtherOther
Capmul® MCM C8 EP/NF COA
Capmul® MCM C8 EP/NF COA
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Capmul® Residual Solvents
Capmul® Residual Solvents
OtherOther
Capmul® RM Origin
Capmul® RM Origin
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Capmul® MCM C8 EP-NF Elemental Impurities
Capmul® MCM C8 EP-NF Elemental Impurities
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Capmul® Bioengineered Statement
Capmul® Bioengineered Statement
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Capmul® Allergens
Capmul® Allergens
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A Compilation of Product Statements AC Products 1 (NG)
A Compilation of Product Statements AC Products 1 (NG)
OtherKnowde Enhanced TDS
Identification & Functionality
Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
Technologies
Capmul® MCM C8 EP/NF Features & Benefits
Applications & Uses
Markets
Dosage Form
Pharmaceutical and Nutritional Applications
- Bioavailability enhancer
- Solubilizer
- Emulsifier / co-emulsifier
- Carrier (vehicle)
- Penetration enhancer (dermatological applications)
Applications
- Permeation Enhancement
- Solubilization
- Emulsification
Properties
Physical Form
Appearance
Typical Properties
| Value | Units | Test Method / Conditions | |
| Peroxide Value | max. 1 | mEq/kg | NF |
| Saponification Value | 266 - 300 | mg KOH/g | NF |
Fatty Acid Composition
| Value | Units | Test Method / Conditions | |
| C10 | max. 10 | % | EP/NF |
| C12 | max. 1.0 | % | EP/NF |
| C14 | max. 0.5 | % | EP/NF |
| C6 | max. 1.0 | % | EP/NF |
| C8 | min. 90.0 | % | EP/NF |
Assay
| Value | Units | Test Method / Conditions | |
| Diacylglycerols | 20.0 - 50.0 | % | EP/NF |
| Monoacylglycerols | 45.0 - 75.0 | % | EP/NF |
| Triacylglycerols | max. 10.0 | % | EP/NF |
Elemental Impurities
| Value | Units | Test Method / Conditions | |
| Arsenic Content | max. 0.1 | 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. 0.1 | μg/g | - |
| Nickel Content | max. 4 | μg/g | - |
| Vanadium Content | max. 1 | μg/g | - |
Specifications
| Value | Units | Test Method / Conditions | |
| Acid Value | max. 3.0 | mg KOH/g | ¹EP/²NF |
| Free Glycerol | max. 3.0 | % | EP/NF |
| Identification Tests³ | Pass | - | EP |
| Total Ash | max. 0.5 | % | EP/NF |
| Water Content | max. 1.0 | % | EP/NF (Karl Fischer) |
Note
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.
¹EP: European Pharmacopeia
²NF: USP/National Formulary
³Compliance to Identification test is certified based on controls in place that assure the identity of the excipient
Regulatory & Compliance
Certifications & Compliance
Grade
Regulatory
- Meets the requirements of the European Pharmacopeia ¹(EP) and United States Pharmacopeia /National Formulary ²(USP/NF) for “Glycerol (Glyceryl)
- Monocaprylate” Type I.
- Mono- and diglycerides are generally recognized as safe (GRAS) when used according to 21 CFR § 184.1505.
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
Storage & Handling
Shelf Life
Recommended Storage and Handling
- Store in tight, light-resistant containers.
- Store in a dry location at ambient temperature.
- Retest/requalify 20 months after date of manufacture.
- 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.Detailed instructions are available upon request.
Capmul® MCM C8 EP/NF
ABITEC Corporation