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Glycerol Distearate

Specializing in the production of pharmaceutical excipients

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Glycerol Distearate

 (CDE REGISTRATION NO.:  F2024000316)

Name: Glycerol Distearate

Other Name: Glyceryl Distearate

CAS No.: 1323-83-7

Packaging: 1kg/bag/carton; 5kg/bag/carton; 20kg/bag/drum

Appearance: Hard, waxy mass or powder, or white or almost white, unctuous flakes.

Practically insoluble in water, soluble in methylene chloride, partly soluble in hot ethanol (96%).

Quality Standard: USP2024, EP11.0

Specifications:

Alpha codeSpecifications
AG5601Type I: Stearic acid: 40.0 per cent to 60.0 per centSum of the contents of palmitic and stearic acids: minimum 90.0 per cent
AG5602Type II: Stearic acid: 60.0 per cent to 80.0 per centSum of the contents of palmitic and stearic acids: minimum 90.0 per cent
AG5603Type III : Stearic acid: 80.0 per cent to 99.0 per centSum of the contents of palmitic and stearic acids: minimum 96.0 per cent

Features:

Glycerol Distearate is a mixture of diglycerides, primarily glyceryl distearate, along with varying amounts of monoglycerides and triglycerides. It contains 8.0% to 22.0% monoglycerides, 40.0% to 60.0% diglycerides, and 25.0% to 35.0% triglycerides.

Applications:

Dosage formApplicationDosage
Granules, dry suspensionTaste masking materials2-6%
TabletLubricants1-4%
Sustained-release preparationsDissolving skeleton material10-20%
OintmentThickening agent, improving spreadability2-10%
Oral Liquid dosage formThickening agent0.5-3%

Advantages:

■ It has been applied to the new hot melt granulation method to produce granules and tablets

■ It is widely used in cosmetics, food, oral and topical preparations, etc. It is generally considered non-toxic and non-irritating to the skin and mucous membranes

■Excellent emulsifying and thickening properties, suitable for various formulations.

Incompatibilities

■Incompatible with strong oxidizing agents (e.g., potassium chlorate, hydrogen peroxide).

■May react with certain metal ions (e.g., aluminum, copper); coexistence should be avoided.

Safety

■According to available data, Glycerol Distearate is considered a low-toxicity substance.

■Safe for use at recommended levels; no significant irritation or allergic reactions have been reported.

■Follow appropriate safety procedures to avoid inhalation of dust and direct contact.

Storage:: Preserve in tight containers. No storage requirements are specified.(USP2024)

Under nitrogen, in an airtight container.(EP11.0)