PharmaVault
گنجینه اطلاعات داروسازی
The Pharmaceutical Information Vault
Excipient monograph · مونوگراف ماده جانبی
pharmavault.ir
Phenylethyl alcohol
فنیل اتیل الکل
1Nonproprietary names
- BPPhenylethyl Alcohol
- USP–NFPhenylethyl Alcohol
2Synonyms and trade names
Benzeneethanol; benzyl carbinol; β-hydroxyethylbenzene; PEA; phenethyl alcohol; 2-phenylethanol; β-phenylethyl alcohol
3Chemical name and CAS Registry Number
2-Phenylethanol · [60-12-8]
UNII ML9LGA7468 · PubChem CID 6054
4Empirical formula and molecular weight
C8H10O · 122.16
5Functional category
Antimicrobial preservative
Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
Used as an antimicrobial preservative in ophthalmic, nasal and otic solutions, typically at 0.25–0.5% v/v, usually together with another preservative such as benzalkonium chloride or chlorhexidine for a synergistic effect. It is also widely used as a flavour and fragrance (rose odour) in foods, cosmetics and toiletries.
7Description
A clear, colourless liquid with a characteristic rose-like odour and a sharp, burning taste. It occurs naturally in rose oil and several other essential oils.
8Typical properties
- Boiling point
- about 219–221 °C
- Density
- about 1.02 g/cm³ (20 °C)
- Refractive index
- about 1.53 (20 °C)
- Solubility
- sparingly soluble in water (about 1 in 60); miscible with ethanol, chloroform, ether, glycerol and fixed oils
9Stability and storage conditions
Stable in bulk, and stable in aqueous solution including on autoclaving. Store in an airtight container, protected from light, in a cool, dry place.
10Incompatibilities
Incompatible with oxidising agents and with protein-containing materials such as serum. Its antimicrobial activity may be partly reduced by polysorbates and other nonionic surfactants.
11Method of manufacture
Produced synthetically, for example by Friedel–Crafts reaction of benzene with ethylene oxide in the presence of aluminium chloride, or by reduction of phenylacetic acid esters; it can also be obtained from natural sources.
12Safety
Widely used in foods, cosmetics and topical and ophthalmic medicines, and generally regarded as non-toxic and non-irritant at the concentrations used as a preservative. Higher concentrations can irritate the eye, and concentrated material is irritant to the skin.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended; the liquid is combustible.
14Regulatory status
Included in the FDA Inactive Ingredient Database (nasal, ophthalmic and otic preparations) and in non-parenteral medicines licensed in Europe. Permitted as a synthetic flavouring substance in foods.
15Related substances
Benzyl alcohol; chlorobutanol; phenoxyethanol.
16Comments
On its own phenylethyl alcohol has relatively weak, slow antimicrobial activity, being more effective against Gram-negative bacteria; it acts mainly by increasing cell-membrane permeability, which explains its usefulness in combination with other preservatives. Activity is greatest at acidic to neutral pH.