Is GLYCERYL PALMITOSTEARATE soluble in water?

It is practically insoluble in water due to its lipid-like structure.

Does GLYCERYL PALMITOSTEARATE have an E-number?

No authoritative EU E-number assignment was found in regulatory databases.

Can GLYCERYL PALMITOSTEARATE be used in food tablets?

Yes, it is affirmed under 21 CFR 184.1329 for use in tablet formulation.

Does the FDA list GLYCERYL PALMITOSTEARATE as GRAS?

Yes, it is listed as GRAS with no limitation other than current good manufacturing practice.

Are there special labeling requirements?

Labeling must comply with FDA requirements for ingredient naming and use conditions.

Is GLYCERYL PALMITOSTEARATE a nutrient?

No, it serves a technical role rather than providing nutritional value.

Is there a JECFA ADI for this compound?

No, authoritative JECFA additive listing with ADI values was not found.

GLYCERYL PALMITOSTEARATE

CAS: 8067-32-1 FORMULATION AID

GLYCERYL PALMITOSTEARATE is a technical formulation aid used in food and pharmaceutical tablets as described by the FDA regulation 21 CFR 184.1329.

...

What It Is

GLYCERYL PALMITOSTEARATE is a food ingredient defined as a formulation aid. It refers to a mixture of mono-, di-, and triglyceride esters derived from the fatty acids palmitic and stearic acids esterified with glycerol. The Chemical Abstracts Service (CAS) number for this compound is 8067-32-1, and it is recognized in regulatory frameworks such as the U.S. Code of Federal Regulations (21 CFR 184.1329). It is listed in the FDA Substances Added to Food (formerly EAFUS) database as a formulation aid used in food applications. Structurally, it is composed of glycerol bound to long-chain fatty acid residues, resulting in a material that is solid or waxy at room temperature and has limited solubility in water, indicative of its lipid-like character. The compound’s primary identification through CAS and its regulatory listing highlight its specific classification as a formulation aid, distinguishing it from direct nutrients or flavor compounds in food systems. GLYCERYL PALMITOSTEARATE is not assigned an E-number in the European Union, and there is no codified JECFA additive number for this substance as a direct food additive on record in commonly indexed sources. The regulation 21 CFR 184.1329 s its use and composition, emphasizing that the mixture of esters meets defined specifications and that it is affirmed as generally recognized as safe (GRAS) under conditions of current good manufacturing practice for its specified function. The compound’s alternate chemical names can reflect its ester composition, a mixture of glycerol esters with palmitic and stearic acids, often referenced in chemical databases and industry catalogs for its technical and formulation role. This technical understanding of GLYCERYL PALMITOSTEARATE clarifies its identity and places it within the regulatory and chemical context of food formulation aids.

How It Is Made

The industrial production of GLYCERYL PALMITOSTEARATE is achieved through the esterification of glycerol with palmitic acid and stearic acid. In this process, glycerol, a triol, is reacted with the fatty acids under controlled heat and catalytic conditions that promote the formation of ester linkages. The resulting product is a mixture of mono-, di-, and triglyceride esters rather than a single pure compound. This mixed glyceride product is then refined to meet specific regulatory and purity criteria for use in food and pharmaceutical applications. The esterification reaction involves removing water produced during the reaction to drive the equilibrium toward ester formation. After synthesis, the material may be purified to remove unreacted glycerol, free fatty acids, catalysts, and other byproducts to achieve consistent quality and performance. The physical appearance of the final product is typically a fine, white to off-white solid or waxy material with limited solubility in water and greater solubility in organic solvents, reflecting its long-chain lipid nature. GLYCERYL PALMITOSTEARATE’s manufacturing focuses on ensuring that the molecular distribution of mono-, di-, and triglycerides falls within acceptable ranges, which can influence its functional characteristics as a formulation aid. Manufacturing controls also include monitoring heavy metal content, specification conformity, and ensuring absence of harmful residues. These measures align with regulatory expectations for food-grade substances used as formulation aids. Throughout processing, standard good manufacturing practices (GMP) and food-grade production conditions are applied. This includes facilities designed to prevent contamination, quality management systems to verify batch consistency, and documentation that supports regulatory compliance. The resulting product, GLYCERYL PALMITOSTEARATE, provides functional properties desirable in tablet and excipient formulations, and its production methods ensure that it meets the quality standards expected for technical use in food and pharmaceutical systems.

Safety & Regulations

FDA

Approved: True
Regulation: 21 CFR 184.1329

EFSA

Notes: No specific EFSA E-number or ADI found in authoritative sources

JECFA

Notes: JECFA additive listing and ADI values not located in authoritative databases

Sources

Found In Products

Compressed Tablet Formulations
Dry Powder Mix Blends
Encapsulated Dietary Supplements
Functional Food Powders
Extruded Snack Base Mixes
Protein Bar Base Mixes
Reduced-Fat Dough Mixes
Vitamin Fortified Beverages
Sugar-Free Tablet Coatings
Ready-to-Drink Supplement Drinks

FAQ

What is GLYCERYL PALMITOSTEARATE used for?

It is used as a formulation aid in tablet and excipient preparations under regulatory practices.

Is GLYCERYL PALMITOSTEARATE safe?

The FDA affirms it as GRAS for its specified use under current good manufacturing practice.

What does the CAS number 8067-32-1 represent?

It uniquely identifies GLYCERYL PALMITOSTEARATE in chemical registries and regulatory contexts.

Comments

No comments yet. Be the first to share!