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Capmul® MCM C8 EP/NF

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Chemical Name: Glyceryl Monocaprylate
Function: Emulsifier, Penetration Enhancer, Bioavailability Enhancer, Solubilizer
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
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TypeDocument Name
Brochure
Lipid Excipient Portfolio
Lipid Excipient Portfolio
Brochure
Brochure
Abitec Pharma Brochure 2021
Abitec Pharma Brochure 2021
Brochure
Other
Capmul® Excipients Guidance for Storage and Handling
Capmul® Excipients Guidance for Storage and Handling
Other
Technical Data Sheet
Capmul® MCM C8 EP/NF Technical Data Sheet
Capmul® MCM C8 EP/NF Technical Data Sheet
Technical Data Sheet
Other
Capmul® Allergens
Capmul® Allergens
Other
Technical Data Sheet
Capmul® MCM C8 EP-NF Elemental Impurities
Capmul® MCM C8 EP-NF Elemental Impurities
Technical Data Sheet
Other
Capmul® MCM C8 EP/NF COA
Capmul® MCM C8 EP/NF COA
Other
Other
Capmul® Bioengineered Statement
Capmul® Bioengineered Statement
Other
Other
Capmul® Residual Solvents
Capmul® Residual Solvents
Other
Other
Capmul® RM Origin
Capmul® RM Origin
Other
Other
A Compilation of Product Statements AC Products 1 (NG)
A Compilation of Product Statements AC Products 1 (NG)
Other

Knowde Enhanced TDS

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Identification & Functionality

Capmul® MCM C8 EP/NF Features & Benefits

Applications & Uses

Pharmaceutical and Nutritional Applications
  • Bioavailability enhancer
  • Solubilizer
  • Emulsifier / co-emulsifier
  • Carrier (vehicle)
  • Penetration enhancer (dermatological applications)
Applications
  • Permeation Enhancement
  • Solubilization
  • Emulsification

Properties

Physical Form
Liquid,Solid
Appearance
Colorless or slightly yellow oily liquid and/or soft mass
Typical Properties
ValueUnitsTest Method / Conditions
Peroxide Valuemax. 1mEq/kgNF
Saponification Value266 - 300mg KOH/gNF
Fatty Acid Composition
ValueUnitsTest Method / Conditions
C10max. 10%EP/NF
C12max. 1.0%EP/NF
C14max. 0.5%EP/NF
C6max. 1.0%EP/NF
C8min. 90.0%EP/NF
Assay
ValueUnitsTest Method / Conditions
Diacylglycerols20.0 - 50.0%EP/NF
Monoacylglycerols45.0 - 75.0%EP/NF
Triacylglycerolsmax. 10.0%EP/NF
Elemental Impurities
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 0.1μg/g-
Cadmium Contentmax. 0.1μg/g-
Cobalt Contentmax. 1μg/g-
Lead Contentmax. 0.1μg/g-
Mercury Contentmax. 0.1μg/g-
Nickel Contentmax. 4μg/g-
Vanadium Contentmax. 1μg/g-
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 3.0mg KOH/g¹EP/²NF
Free Glycerolmax. 3.0%EP/NF
Identification Tests³Pass-EP
Total Ashmax. 0.5%EP/NF
Water Contentmax. 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

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

Packaging Type
Standard Packaging
  • 425 lb (192.8 kg) drum
  • 50 lb (22.7 kg) HDPE jerrican

Storage & Handling

Shelf Life
20 months
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