CETYL ESTERS WAX

Chemical properties

Cetyl esters wax occurs as white to off-white, somewhat translucent flakes (typically in the range of 5 mm to several millimeters in the largest dimension), having a crystalline structure and a pearly luster when caked. It has a faint, aromatic odor and a bland, mild taste.

Production Methods

Cetyl esters wax is prepared by the direct esterification of the appropriate mixtures of fatty alcohols and fatty acids.

Flammability and Explosibility

Non flammable

Pharmaceutical Applications

Cetyl esters wax is a stiffening agent and emollient used in creams and ointments as a replacement for naturally occurring spermaceti. Cetyl esters wax is hydrophobic and has been proposed as a suitable component of an ophthalmic gelatin-based, controlledrelease delivery matrix.
The physical properties of cetyl esters wax vary greatly from manufacturer to manufacturer owing to differences between the mixtures of fatty acids and fatty alcohol esters that are used. Differences between products appear most obviously in the melting point, which can range from 43–47℃ (USP32–NF27 range) to 51–55°C, depending on the mixture. Materials with a high melting point tend to contain predominantly cetyl and stearyl palmitates.

Safety Profile

An eye irritant. When heated to decomposition it emits acrid smoke and irritating fumes.

Safety

Cetyl esters wax is an innocuous material generally regarded as essentially nontoxic and nonirritant.
LD50 (rat, oral): >16 g/kg

Storage

Store in a well-closed container in a cool, dry place. Avoid exposure to excessive heat (above 40℃).

Incompatibilities

Incompatible with strong acids or bases.

Regulatory Status

Included in the FDA Inactive Ingredients Database (topical preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.