Emulsifyingwax Property

solubility 

Soluble in chloroform, ether and, on warming, in fixed oils and mineral oil. The PhEur 6.2 specifies that cetostearyl alcohol, emulsifying (type A and type B) are soluble in hot water giving an opalescent solution, practically insoluble in cold water, and slightly soluble in ethanol (96%). The BP 2009 specifies that emulsifying wax is practically insoluble in water (forms an emulsion); partly soluble in ethanol (96%).

Hazard and Precautionary Statements (GHS)

Emulsifyingwax Chemical Properties,Usage,Production

Chemical Properties

An almost white or pale yellow colored, waxy solid or flakes which when warmed become plastic before melting. Anionic emulsifying wax has a faint characteristic odor and a bland taste.

Production Methods

Anionic emulsifying wax is prepared by melting cetostearyl alcohol and heating to about 95℃. Sodium lauryl sulfate, or some other suitable anionic surfactant, and purified water are then added. The mixture is heated to 115℃ and, while this temperature is maintained, the mixture is stirred vigorously until any frothing ceases. The wax is then rapidly cooled.

Pharmaceutical Applications

Anionic emulsifying wax is used in cosmetics and topical pharmaceutical formulations primarily as an emulsifying agent. The wax is added to fatty or paraffin bases to facilitate the production of oil-in-water emulsions that are nongreasy. In concentrations of about 2%, emulsions are pourable; stiffer emulsions, e.g. aqueous cream BP, may contain up to 10% of anionic emulsifying wax.
Creams should be adequately preserved and can usually be sterilized by autoclaving. A better-quality emulsion is produced by incorporating some alkali into the aqueous phase, although care should be taken not to use an excess.
Anionic emulsifying wax (3–30%) may also be mixed with soft and liquid paraffins to prepare anhydrous ointment bases such as emulsifying ointment BP. A preparation of 80% anionic emulsifying wax in white soft paraffin has been used as a soap substitute in the treatment of eczema.
In addition, anionic emulsifying wax (10%) has been added to theobroma oil (cocoa butter) to produce a suppository base with a melting point of 34℃.

Safety

Anionic emulsifying wax is used primarily in topical pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material. However, sodium lauryl sulfate, a constituent of anionic emulsifying wax, is known to be irritant to the skin at high concentrations; sodium cetyl sulfate is claimed to be less irritating.
Emulsifying ointment BP, which contains anionic emulsifying wax, has been found to have major sunscreen activity in clinically normal skin and should therefore not be used before phototherapy procedures.

storage

Solid anionic emulsifying wax is chemically stable and should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Incompatibilities of anionic emulsifying wax are essentially those of sodium alkyl sulfates and include cationic compounds ( quaternary ammonium compounds, acriflavine, ephedrine hydrochloride, antihistamines, and other nitrogenous compounds), salts of polyvalent metals (aluminum, zinc, tin, and lead), and thioglycolates. Anionic emulsifying wax is compatible with most acids above pH 2.5. It is also compatible with alkalis and hard water.
Iron vessels should not be used when heating anionic emulsifying wax; stainless steel containers are satisfactory.

Regulatory Status

Included in the FDA Inactive Ingredients Database (rectal emulsions and aerosol foams; topical aerosols, emulsions, creams, lotions, and ointments). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.