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Capmul® PG-2L EP/NF

Capmul® PG-2L EP/NF is a mixture of the propylene glycol mono- and diesters of lauric (dodecanoic) acid. It contains not less than 70.0 percent of diesters and not more than 30.0 percent of monoesters. Capmul® PG-2L EP/NF may be appropriate for microemulsions, soft gelatin capsules, suppositories, suspensions, and/or topical applications. It is manufactured in USA.

Brand: Capmul (31 products)

Chemical Name: Propylene Glycol Dilaurate

CAS Number: 22788-19-8

Functions: Bioavailability Enhancer, Carrier, Emulsifier, Solubilizer, Viscosity Modifier

Dosage Form: Capsules, Suppositories, Suspension, 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, European Pharmacopeia (Ph. Eur.), 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: 1,2-Propylene glycol dilaurate

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
Propylene Glycol Dilaurate
Pharma & Nutraceuticals Functions
Bioavailability Enhancer,
Carrier,
Emulsifier,
Solubilizer,
Viscosity Modifier
CAS No.
22788-19-8
EC No.
245-217-3
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Carriers & Bulking Agents,
Emulsifiers & Stabilizers,
Formulation & Processing Aids,
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
Oral,
Rectal,
Topical
Dosage Form
Capsules,
Suppositories,
Suspension,
Tablets
Applications
  • Solubilizer
  • Carrier / vehicle
  • Emollient
  • Bio-availability enhancer
  • Viscosity modifier
  • Permeation enhancer

Properties

Physical Form
Liquid
Appearance
Clear oily liquid colorless or slightly yellow
Fatty Acid Composition
ValueUnitsTest Method / Conditions
C10max. 2.0wt%EP / NF
C12min. 95wt%EP / NF
C14max. 3.0wt%EP / NF
C16max. 1.0wt%EP / NF
C8max. 0.5wt%EP / NF
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 4.0mg KOH/gEP / 2NF
IdentificationPass-EP / NF
Iodine Valuemax. 1cg I2/gEP / NF
Propylene Glycolmax. 2.0%EP / NF
Propylene Glycol Diestersmin. 70.0%EP / NF
Propylene Glycol Mono Estersmax. 30.0%EP / NF
Saponification Value230 - 250mg KOH/gEP / NF
Total Ashmax. 0.1%EP / NF
Water Contentmax. 1.0%EP / NF
Note

EP: European Pharmacopeia
USP/NF: United States Pharmacopeia/National Formulary

Regulatory & Compliance

Certifications & Compliance
BRC Certified,
European Pharmacopeia (Ph. Eur.),
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
Standard Packaging
  • 400 lb (181.4 kg) 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 well-closed containers protected from moisture