Glycerol Distearate | Glyceryl Distearate | Pharmaceutical Excipient Supplier
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Glycerol Distearate, also known as Glyceryl Distearate or Distearin, is a versatile pharmaceutical excipient used as an emulsifier, stabilizer, and lubricant.
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 code Specifications AG5601 Type 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 AG5602 Type 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 AG5603 Type 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 form Application Dosage Granules, dry suspension Taste masking materials 2-6% Tablet Lubricants 1-4% Sustained-release preparations Dissolving skeleton material 10-20% Ointment Thickening agent, improving spreadability 2-10% Oral Liquid dosage form Thickening agent 0.5-3%
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)
