Description

Gelucire 50-02 is a semi-solid, non-ionic surfactant excipient derived from polyethylene glycol (PEG) esters of fatty acids, with the CAS registry number 125622-72-2. It serves as a critical multifunctional ingredient, primarily valued for its solubilizing, emulsifying, and controlled-release matrix-forming properties. This product is essential for formulators in the pharmaceutical and nutraceutical industries seeking to enhance the bioavailability of poorly soluble active ingredients.

Application

• Pharmaceutical Solid Dispersion: Used as a carrier in hot-melt extrusion and melt granulation to improve the dissolution rate and oral absorption of Biopharmaceutics Classification System (BCS) Class II and IV drugs.
• Lipid-Based Drug Delivery Systems: A key component in self-emulsifying drug delivery systems (SEDDS) and self-microemulsifying drug delivery systems (SMEDDS) for encapsulating lipophilic compounds.
• Controlled-Release Matrices: Acts as a hydrophilic matrix former in sustained-release tablet and capsule formulations to modulate drug release profiles.
• Solubility & Bioavailability Enhancement: Employed to solubilize active pharmaceutical ingredients (APIs) in liquid and semi-solid dosage forms like soft gelatin capsules.
• Nutraceutical & Cosmetic Formulations: Functions as an emulsifier and stabilizer in dietary supplements and topical creams/ointments.

Basic Information

Product Name	Gelucire 50-02
CAS No.	125622-72-2
Molecular Formula	Mixture (PEG esters of fatty acids)
Molecular Weight	Contact for details
Synonyms	Gelucire 50/02; Polyglycolized Glycerides, Type 50; Lauroyl Macrogolglycerides; PEG-32 Glyceryl Laurate; Gattefossé Gelucire 50/02; D-α-Tocopheryl Polyethylene Glycol 1000 Succinate Related Excipient (in context); Semi-Solid Polyethylene Glycol Ester Surfactant
EINECS	Contact for details

Quality Control

Our Gelucire 50-02 is manufactured and tested to meet high-quality standards suitable for pharmaceutical applications. Production follows current Good Manufacturing Practices (cGMP) guidelines. Each batch is supported by a comprehensive Certificate of Analysis (COA) that includes critical parameters such as acid value, saponification value, hydroxyl value, and melting point. We ensure consistent quality and traceability for global regulatory compliance, including ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed after opening to prevent absorption of atmospheric moisture, which can alter its physical properties.

Specification

Item	Specification
Description	White to off-white waxy solid
Identification (IR)	Conforms
Melting Point	46 - 51 °C
Acid Value	≤ 2.0 mg KOH/g
Saponification Value	65 - 85 mg KOH/g
Hydroxyl Value	40 - 60 mg KOH/g
Heavy Metals	≤ 10 ppm
Water Content	≤ 1.0 %

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.