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.
