Capmul - PG-2L EP/NF - ABITEC - 22788-19-8 - Capsules

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

	Value	Units	Test Method / Conditions
Acid Value	max. 4.0	mg KOH/g	EP / 2NF
Identification	Pass	—	EP / NF
Iodine Value	max. 1	cg I2/g	EP / NF
Propylene Glycol	max. 2.0	%	EP / NF
Propylene Glycol Diesters	min. 70.0	%	EP / NF
Propylene Glycol Mono Esters	max. 30.0	%	EP / NF
Saponification Value	230 - 250	mg KOH/g	EP / NF
Total Ash	max. 0.1	%	EP / NF
Water Content	max. 1.0	%	EP / NF

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

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

Capmul® PG-2L EP/NF