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Stearyl alcohol
استئاریل الکل
1Nonproprietary names
- BPStearyl Alcohol
- JPStearyl Alcohol
- Ph. Eur.Stearyl Alcohol
- USP–NFStearyl Alcohol
2Synonyms and trade names
alcohol stearylicus; Crodacol S95; Lanette 18; 1-octadecanol; octadecyl alcohol
3Chemical name and CAS Registry Number
Octadecan-1-ol · [112-92-5]
UNII 2KR89I4H1Y · PubChem CID 8221
4Empirical formula and molecular weight
C18H38O · 270.49
5Functional category
Semi-solid base, emollient
Typical concentrations: — · Dosage forms: Semi-solid
6Applications in pharmaceutical formulation
Used in creams and ointments as a stiffening agent and co-emulsifier: it increases viscosity, stabilises emulsions and increases the water-holding capacity of ointment bases. Hydrophilic Ointment USP, for example, contains 25% w/w. It has also been used as a matrix-forming agent in sustained-release tablets and in cosmetics.
7Description
Hard, white, waxy pieces, flakes or granules with a faint characteristic odour and a bland taste. It is a mixture of solid aliphatic alcohols consisting mainly of stearyl alcohol (Ph. Eur.: at least 95%).
8Typical properties
- Melting point
- about 55–60 °C
- Hydroxyl value
- ≈ 195–220
- Iodine value
- not more than 2
- Solubility
- soluble in chloroform, ethanol (95%) and ether; practically insoluble in water
9Stability and storage conditions
Stable to acids and alkalis and does not usually become rancid. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents.
11Method of manufacture
Made by catalytic hydrogenation (reduction) of stearic acid or its esters derived from vegetable or animal fats, followed by purification; it can also be produced synthetically from petrochemical feedstocks.
12Safety
Generally regarded as non-toxic and non-irritant in topical use. Occasional hypersensitivity reactions, mainly contact dermatitis and urticaria, have been attributed to it, though these are less frequent than with cetyl or cetostearyl alcohol.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended. It is combustible.
14Regulatory status
Permitted in the USA as a synthetic fatty alcohol food additive. Included in the FDA Inactive Ingredient Database (topical and vaginal preparations, and some oral products) and in non-parenteral medicines licensed in Europe.
15Related substances
Anionic emulsifying wax; cetostearyl alcohol; cetyl alcohol; nonionic emulsifying wax.
16Comments
Stearyl alcohol gives firmer creams than cetyl alcohol of similar concentration. In combination with a hydrophilic surfactant it forms a gel network in the continuous phase of o/w creams, which accounts for much of their consistency.