Description
A purified, yellowish white, semisolid, fatlike substance extracted
from the wool of sheep. It is insoluble in water, but mixes with
about twice its weight of water without separation. It is soluble in
chloroform and in ether.
Chemical Properties
Hydrous lanolin is a pale yellow-colored, unctuous substance with a
faint characteristic odor. When melted by heating on a water bath,
hydrous lanolin separates into a clear oily layer and a clear water
layer.
Uses
lanolin USP (modified) is an emollient and an emulsifier. This is a highly purified lanolin that meets uSP monograph specifications requiring analysis for trace contaminants.
Definition
LANOLIN is a complex combination of waxes obtained from sheep's wool. It consists primarily of cholesterol and triterpene alcohols and their esters.
Production Methods
Lanolin is melted, and sufficient purified water is gradually added
with constant stirring.
Pharmaceutical Applications
Hydrous lanolin is widely used in topical pharmaceutical formulations
and cosmetics in applications similar to those for lanolin.
Hydrous lanolin is commonly used in the preparation of waterin-
oil creams and ointments. More water may be incorporated into
hydrous lanolin than into lanolin.
Safety
Hydrous lanolin is used in cosmetics and a number of topical
pharmaceutical formulations and is generally regarded as a
nontoxic and nonirritant material, although it has been associated
with hypersensitivity reactions. See Lanolin for further information.
storage
Hydrous lanolin should be stored in a well-filled, well-closed
container protected from light, in a cool, dry place. Normal storage
life is 2 years.
Regulatory Status
Included in the FDA Inactive Ingredients Database (ophthalmic,
topical, transdermal, and vaginal preparations). Included in
nonparenteral medicines licensed in the UK. Included in the
Canadian List of Acceptable Non-medicinal Ingredients.
