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Cetyl alcohol
ستیل الکل
1Nonproprietary names
- BPCetyl Alcohol
- JPCetanol
- Ph. Eur.Cetyl Alcohol
- USP–NFCetyl Alcohol
2Synonyms and trade names
alcohol cetylicus; cetanol; ethal; 1-hexadecanol; n-hexadecyl alcohol; palmityl alcohol; Crodacol C; Lanette 16; Speziol C16
3Chemical name and CAS Registry Number
Hexadecan-1-ol · [36653-82-4]
UNII 936JST6JCN · PubChem CID 2682
4Empirical formula and molecular weight
C16H34O · 242.44
5Functional category
Semi-solid base, emollient, Surfactant, emulsifier
Typical concentrations: 2–5% emollient · 2–10% stiffening · Dosage forms: Semi-solid
6Applications in pharmaceutical formulation
Used in creams, lotions and ointments for its emollient, emulsifying, stiffening and water-absorbing properties, and in suppositories and modified-release solid dosage forms. Typical concentrations: emollient 2–5%; emulsifying agent 2–5%; stiffening agent 2–10%; water absorption 5%. Added to petrolatum, about 5% markedly increases the amount of water the base can take up, and in oil-in-water emulsions it acts as a co-emulsifier that improves stability and texture.
7Description
Waxy, white flakes, granules, cubes or castings with a faint characteristic odour and a bland taste. Pharmacopoeial material contains mainly hexadecan-1-ol together with smaller amounts of related aliphatic alcohols, chiefly octadecan-1-ol.
8Typical properties
- Melting point
- about 45–52 °C (pharmacopoeial grades); about 49 °C for the pure compound
- Boiling point
- about 316–344 °C
- Hydroxyl value
- 218–238
- Iodine value
- not more than 2
- Solubility
- freely soluble in ethanol (95%) and ether; solubility increases with temperature; practically insoluble in water; miscible with fats and paraffins when melted
9Stability and storage conditions
Stable in the presence of acids, alkalis, light and air, and does not become rancid. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents. It may lower the melting point of some drugs, such as ibuprofen, which can cause sticking during film coating of tablets containing both.
11Method of manufacture
Made by catalytic hydrogenation of palmitic acid or its esters obtained from vegetable oils such as palm or coconut oil, with subsequent purification; it was formerly obtained from spermaceti. Synthetic routes from petrochemical sources are also used.
12Safety
Widely used in topical products and regarded as essentially non-toxic and non-irritant; it is poorly absorbed from the gastrointestinal tract. Contact sensitisation has been reported occasionally, more often with less pure grades.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended. Molten cetyl alcohol can cause burns, and the material is combustible.
14Regulatory status
Included in the FDA Inactive Ingredient Database (oral capsules and tablets; rectal, topical and vaginal preparations) and in non-parenteral medicines licensed in Europe.
15Related substances
Cetostearyl alcohol; stearyl alcohol; myristyl alcohol; cetyl palmitate; cetyl esters wax.
16Comments
Cetyl alcohol on its own is a weak water-in-oil emulsifier; in oil-in-water creams it is used together with a hydrophilic surfactant, with which it forms a stabilising gel network. Cetostearyl alcohol is often preferred because the mixed alcohols give more stable creams.