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Capmul® MCM C8 EP/NF

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.

Brand: Capmul (31 products)

Chemical Name: Glyceryl Monocaprylate

CAS Number: 93906-96-8

Functions: Bioavailability Enhancer, Emulsifier, Penetration Enhancer, Solubilizer

Dosage Form: Capsules, Creams, Lotions, Ointments, Tablets

Labeling Claims: Aflatoxin-free, Allergen-free, BSE-free, CMR Substances-free, Mycotoxins-free, Non-GMO, Polychlorinated Biphenyls (PCB)-free, TSE-free, Vegan

Certifications & Compliance: BRC Certified, European Pharmacopeia (Ph. Eur.), FDA Compliant, FDA IID, GFSI Certified, GMP, Generally Recognized As Safe (GRAS), Hazard Analysis Critical Control Point (HACCP), ISO 14001, ISO 45001, ISO 9001, National Formulary (NF), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP), Vegan

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

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
Glyceryl Monocaprylate
Pharma & Nutraceuticals Functions
Bioavailability Enhancer,
Emulsifier,
Penetration Enhancer,
Solubilizer
CAS No.
93906-96-8
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Emulsifiers & Stabilizers,
Other Excipients,
Solvents & Solubilizers

Features & Benefits

Labeling Claims
Aflatoxin-free,
Allergen-free,
BSE-free,
CMR Substances-free,
Mycotoxins-free,
Non-GMO,
Polychlorinated Biphenyls (PCB)-free,
TSE-free,
Vegan

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Nasal,
Oral,
Topical,
Transdermal
Dosage Form
Capsules,
Creams,
Lotions,
Ointments,
Tablets
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

Certifications & Compliance
BRC Certified,
European Pharmacopeia (Ph. Eur.),
FDA Compliant,
FDA IID,
GFSI Certified,
GMP,
Generally Recognized As Safe (GRAS),
Hazard Analysis Critical Control Point (HACCP),
ISO 14001,
ISO 45001,
ISO 9001,
National Formulary (NF),
The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA),
United States Pharmacopeia (USP),
Vegan
Grade
Pharma 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

Packaging Type
Drums,
Jerrycan
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.