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Capmul® PG-8 NF

Capmul® PG-8 NF is Type II Propylene Glycol Monocaprylate, a propylene glycol monoester of caprylic acid. It is an excellent solvent and a good bioavailability enhancer for many complex, poorly soluble drug compounds. Capmul® PG-8 NF is used primarily as a carrier in soft and hard gelatin capsules and a penetration enhancer in transdermal drug delivery systems. It is manufactured in USA.

Brand: Capmul (31 products)

Chemical Name: Propylene Glycol Monocaprylate

CAS Number: 31565-12-5

Functions: Bioavailability Enhancer, Carrier, Emulsifier, Skin Penetrant, Solubilizer, Solvent

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

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

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

Synonyms: Propylene glycol monooctanoate

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
Propylene Glycol Monocaprylate
Pharma & Nutraceuticals Functions
Bioavailability Enhancer,
Carrier,
Emulsifier,
Skin Penetrant,
Solubilizer,
Solvent
CAS No.
31565-12-5
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Carriers & Bulking Agents,
Emulsifiers & Stabilizers,
Other Excipients,
Solvents & Solubilizers

Features & Benefits

Labeling Claims
Aflatoxin-free,
Allergen-free,
BSE-free,
CMR Substances-free,
Kosher,
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
Applications
  • Solvent
  • Bioavailability enhancer
  • Carrier
  • Penetration enhancer for transdermal applications
  • Solubilization
  • Emulsification

Properties

Physical Form
Liquid
Appearance
Clear liquid
Fatty Acid Composition
ValueUnitsTest Method / Conditions
C10max. 3.0%NF
C12max. 3.0%NF
C14max. 3.0%NF
C16max. 1.0%NF
C8min. 90.0%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. 2μg/g-
Vanadium Contentmax. 1μg/g-
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 1.5mg KOH/g1NF
Free Propylene Glycolmax. 1.5%NF
IdentificationPass-NF
Iodine Valuemax. 1cg I2/gNF
Peroxide Valuemax. 6.0mEq/kgNF
PG Mono Estersmin. 90.0%NF
Propylene Glycol Diestersmax. 10.0%NF
Saponification Value270 - 295mg KOH/gNF
Total Ashmax. 0.1%NF
Water Contentmax. 1.0%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.

USP/NF: United States Pharmacopeia/National Formulary

Regulatory & Compliance

Certifications & Compliance
BRC Certified,
FDA Compliant,
GFSI Certified,
GMP,
Generally Recognized As Safe (GRAS),
Hazard Analysis Critical Control Point (HACCP),
ISO 14001,
ISO 45001,
ISO 9001,
Kosher,
National Formulary (NF),
The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA),
United States Pharmacopeia (USP),
Vegan
Grade
Pharma Grade
Regulatory
  • Complies with the EP and USP/NF Monographs for Propylene Glycol Dilaurate

 

Food Additive

  • US: Title 21 CFR 172.856, “Propylene glycol mono- and diesters of fats and fatty acids” approved as food additives for direct addition to food for human consumption.
  • Europe: E 477, if tested
  • Japan: Japanese Standards of Food Additives “Propylene glycol esters of fatty acids,” if tested.

Packaging & Availability

Packaging Type
Drums,
Jerrycan
Standard Packaging
  • 425 lb (192.8 kg) drum
  • 50 lb (22.7 kg) jerrican

Storage & Handling

Shelf Life
36 months
Recommended Storage and Handling
  • Retest/requalify 36 months from date of manufacture.
  • Store in tightly closed containers in a cool dry place and protected from moisture.