Glyceryl monostearate

1. Product Overview

Glyceryl Monostearate (GMS) is a lipophilic non-ionic surfactant belonging to the glycerol mono-fatty acid ester family. It is produced through the esterification of glycerol with stearic acid (derived from vegetable or animal fats and oils) or through glycerolysis of fats and oils, resulting in a mixture of mono-, di-, and triglycerides .

Its chemical formula is typically represented as C₂₁H₄₂O₄ with molecular weight of 358.6 g/mol and CAS number 31566-31-1 . Commercial GMS appears as white to cream-colored waxy flakes, beads, powders, or pellets, solid at room temperature .

Glyceryl monostearate is one of the oldest and most widely used emulsifiers globally. Its molecular structure features both hydrophilic hydroxyl groups (-OH) and a lipophilic long alkyl chain, enabling it to significantly reduce interfacial tension between oil and water phases, forming stable emulsions . It is an indispensable ingredient across the food, pharmaceutical, cosmetic, and industrial sectors.

2. Key Features

• Excellent Emulsification & Stabilization: Functions as an effective water-in-oil (W/O) or oil-in-water (O/W) emulsifier, forming stable emulsions and preventing phase separation. Acts as a thickener and stabilizer, imparting smooth texture to products like ice cream and creams .

• Multifunctional Versatility: Serves not only as an emulsifier but also as a:

• Pharmaceutical excipient: Sustained-release matrix material, tablet lubricant

• Cosmetic ingredient: Emollient, plasticizer, pigment dispersant

• Food additive: Starch complexing agent, texture modifier

• High Safety Profile: Recognized as Generally Recognized as Safe (GRAS) by the FDA for food use . Generally regarded as non-toxic and non-irritating in cosmetic and pharmaceutical applications .

• Excellent Compatibility: Compatible with other co-emulsifiers, oils, and active ingredients. When combined with PEG-75 stearate, it can stabilize challenging active pharmaceutical ingredient (API) systems .

• Controllable Quality & Sourcing: Available in various purity grades (40-55% monoester standard grade to ≥90% high-purity grade) and sources (vegetable-derived or synthetic) to meet specific application requirements .

• Good Thermal Stability: High melting point (≥55°C) ensures stability during heating, emulsification, and cooling processes. GMS-based oleogels demonstrate excellent shelf-life and thermal stability for sustained drug delivery applications .

3. Technical Specifications with Explanations

Based on USP/NF, Ph. Eur., JP, and food additive standards:

4. Applications

Food Industry

• Baked Goods: Functions as a dough conditioner and anti-staling agent in bread and cakes, improving texture and retarding starch retrogradation to maintain freshness .

• Dairy & Frozen Desserts: Acts as an emulsifier and stabilizer in ice cream, controlling fat agglomeration to produce smooth, creamy texture with good melt resistance. Stabilizes emulsions in whipped toppings and margarine .

• Confectionery: Reduces viscosity and prevents fat bloom in chocolate; serves as an emulsifier in toffees and caramels to prevent oil separation .

• Other Applications: Stabilizer in protein beverages; thickener and color stabilizer in flavors and fragrances .

Pharmaceutical Industry

• Pharmaceutical Excipient: Functions as a tablet lubricant and coating agent, facilitating compression during tablet manufacturing .

• Sustained-Release Formulations: Serves as a matrix-forming agent for oral sustained-release tablets, pellets, and veterinary boluses, controlling drug release kinetics .

• Long-Acting Injectable Systems: Recent research demonstrates GMS-based oleogels as effective long-acting local anesthetic delivery systems, providing significantly prolonged anesthesia duration compared to liposomal bupivacaine through sustained drug release .

• Emulsifying Agent: Used in preparing O/W or W/O emulsion bases for creams, ointments, and suppositories .

Cosmetics & Personal Care

• Skin Care & Color Cosmetics: Widely used as an emulsifier, emollient, and thickener in creams, lotions, foundations, and sunscreens, providing stable texture and silky feel .

• Hair Care: Functions as an emulsifier and conditioning agent in conditioners and hair masks, imparting smoothness and manageability .

• Other Applications: Used in antiperspirants, baby care products, and other personal care formulations .

Industrial Applications

• Plastics Industry: Acts as a lubricant and antistatic agent in resin processing .

• Textile Industry: Component in fiber finishing oils and processing aids .

5. Product Grade Comparison

6. Purchasing & Selection Guide

Select by Application Area

1. Food Manufacturers:

• Standard Grade (40-55% monoester) suitable for most food applications (bakery, dairy, confectionery)

• Verify compliance with local regulations (FDA 21 CFR, EU E471)

• Request Certificate of Analysis confirming acid value, melting point, and heavy metals compliance

• Certificate of Analysis with batch-specific data

• Drug Master File (DMF) access

• cGMP manufacturing certification

• Must select Pharmaceutical Grade meeting USP/NF or Ph.Eur. standards

• Require comprehensive documentation:

• For sustained-release formulations, verify monoester content and purity

• For topical applications, ensure appropriate grade selection

• High Purity Grade (≥90% monoester) for premium formulations requiring maximum purity and performance

• Self-Emulsifying Grade for simplified O/W emulsion preparation

• Verify cosmetic-grade specifications including color, odor, and heavy metals

• High Purity Grade for sustained-release research, oleogel studies

• Request Certificate of Analysis with complete characterization

Critical Selection Considerations

• Monoester Content: Higher monoester content = higher purity and emulsifying efficiency

• Physical Form: Flakes for general use; powder for easier dissolution; pellets for handling

• Source: Verify vegetable/animal source based on application requirements (vegan, kosher, halal)

• Self-Emulsifying Grades: Contain added emulsifiers; verify HLB value for your specific application

• Regulatory Compliance: Ensure grade meets target market regulations for intended application

7. Frequently Asked Questions (FAQ)

Q: What is the HLB value of glyceryl monostearate and what does it mean?

A: Pure glyceryl monostearate has an HLB value of 3.0-4.0 , indicating strong lipophilic character suitable for water-in-oil (W/O) emulsions and as a stabilizer in oil-in-water (O/W) emulsions when combined with high-HLB emulsifiers. Self-emulsifying grades containing co-emulsifiers have higher HLB values (e.g., 8 ± 1 ) for simplified O/W emulsion preparation .

Q: What is the difference between standard GMS and high-purity GMS?

A: Standard GMS contains 40-55% monoester along with di- and triglycerides, making it suitable for general food and industrial applications. High-purity GMS contains ≥90% monoester, offering higher emulsifying efficiency and purity for demanding pharmaceutical, cosmetic, and research applications .

Q: Is glyceryl monostearate safe for use in food and cosmetics?

A: Yes, GMS has an excellent safety profile. It is GRAS (Generally Recognized as Safe) by the FDA for food use and is widely accepted as non-toxic and non-irritating in cosmetic and pharmaceutical applications . It is approved as food additive E471 in the EU.

Q: How should glyceryl monostearate be stored?

A: Store in tightly sealed containers in a cool, dry, well-ventilated area away from direct sunlight, heat sources, and strong oxidizing agents . Protect from moisture. Under proper conditions, shelf life is typically 2 years . Improper storage can lead to increased acid value and degradation .

Q: How do I incorporate GMS into my formulation?

A: Due to its high melting point (≥55°C), GMS must be incorporated by heating. For emulsions:

• Add to oil phase ingredients

• Heat together to 65-75°C (above melting point) until completely melted and dissolved

• Combine with heated water phase with mixing

• For self-emulsifying grades, follow manufacturer's specific instructions

Q: Can GMS be used in vegan products?

A: Yes, but depends on the stearic acid source. Vegetable-derived GMS (from palm or coconut oil) is suitable for vegan formulations. Always verify the source with your supplier and request documentation for vegan certification if required .

Q: What is the difference between GMS and self-emulsifying GMS?

A: Self-emulsifying GMS contains added emulsifiers (such as soaps, PEG esters, or other surfactants) that allow it to form O/W emulsions more easily, often without the need for additional emulsifiers. It has a higher HLB value (typically 8 ± 1) compared to pure GMS (HLB 3-4) .

Q: What is the role of GMS in sustained-release pharmaceutical formulations?

A: GMS serves as a hydrophobic matrix-forming agent in oral sustained-release tablets and pellets. When combined with drugs, it forms a matrix that slowly erodes or allows drug diffusion over extended periods, controlling release kinetics . Recent research also demonstrates its utility in long-acting injectable oleogels .

8. Delivery, Certification & Service

Delivery Capabilities

• Inventory Status: Multiple grades available from regional warehouses (Asia, Europe, Americas)

• Sample Program: Small quantities available for qualified customers for formulation testing and evaluation

• Packaging Options:

• Research quantities: 1 kg, 5 kg bags/containers

• Industrial quantities: 25 kg multi-layer paper bags, fiber drums, or cartons

• Bulk quantities: 500 kg supersacks, palletized, 20 MT containers

• Custom packaging: Available for volume customers

• Shipping: Non-hazardous material; standard freight shipping available

Quality Certifications

• Certificate of Analysis (COA) provided with each batch for qualified grades, documenting:

• Appearance and color

• Melting point

• Acid value

• Monoester content

• Saponification value (where applicable)

• Iodine value (where applicable)

• Heavy metals (where applicable)

• Safety Data Sheet (SDS) available in multiple languages

• Product Specification (PS) documenting chemical and physical properties

• Certificates of Origin (COO) available upon request

• Additional certifications available:

• USP/NF/Ph.Eur. certification for pharmaceutical grades

• Food-grade (E471) compliance documentation

• KOSHER certification

• HALAL certification

• ISO 9001 quality management certification

• GMP documentation for pharmaceutical grades

• Non-GMO declaration

• Allergen statement

Regulatory Compliance

• Food Grade: Meets FCC, E471 specifications

• Pharmaceutical Grade: Listed in USP/NF and Ph. Eur.

• FDA: Recognized as GRAS for food use

• Export Documentation: Full compliance package for international shipping

Technical Support & Services

• Technical Consultation: Application specialists available for:

• Grade selection guidance

• Formulation development support

• Emulsification optimization

• Sustained-release formulation development

• Regulatory compliance questions

• Custom Services: Tailored packaging, blending, and quality specifications for qualified customers

• Regulatory Support: Documentation for global compliance and product registration

Documentation Available

• Certificate of Analysis (COA) with batch-specific data

• Safety Data Sheet (SDS/MSDS)

• Technical Data Sheet (TDS)

• Product Specification (PS)

• Certificate of Origin (COO)

• KOSHER certificate

• HALAL certificate

• Non-GMO declaration

• Allergen statement

• ISO certifications

• GMP compliance statement (pharmaceutical grades)

• USP/Ph.Eur. certification