PharmaVault
گنجینه اطلاعات داروسازی
The Pharmaceutical Information Vault
Excipient monograph · مونوگراف ماده جانبی
pharmavault.ir
Phenoxyethanol
فنوکسی اتانول
1Nonproprietary names
- BPPhenoxyethanol
- Ph. Eur.Phenoxyethanol
2Synonyms and trade names
2-Phenoxyethanol; ethylene glycol monophenyl ether; β-hydroxyethyl phenyl ether; phenoxetol; phenoxyethanolum; phenyl cellosolve
3Chemical name and CAS Registry Number
2-Phenoxyethanol · [122-99-6]
UNII HIE492ZZ3T · PubChem CID 31236
4Empirical formula and molecular weight
C8H10O2 · 138.16
5Functional category
Antimicrobial preservative
Typical concentrations: 0.5–1% · Dosage forms: Semi-solid, Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
An antimicrobial preservative used in topical creams, lotions and shampoos, usually at 0.5–1.0% w/w, and in some vaccines and other injectable products at about 0.5%. It is widely used in cosmetics, where the EU maximum is 1%. It is often combined with parabens or other preservatives to broaden the spectrum of activity.
7Description
A colourless, slightly viscous, oily liquid with a faint, pleasant aromatic odour and a burning taste.
8Typical properties
- Boiling point
- about 245 °C
- Melting point
- about 14 °C
- Density
- about 1.11 g/cm³ (20 °C)
- Solubility
- slightly soluble in water (roughly 2.5% w/v); miscible with acetone, ethanol and glycerol; slightly soluble in fixed oils
9Stability and storage conditions
Stable and not volatile at room temperature; aqueous solutions can be sterilised by autoclaving. Store in a well-closed container in a cool, dry place, protected from light.
10Incompatibilities
Its antimicrobial activity can be reduced by nonionic surfactants and by sorption onto some plastics such as PVC. It is incompatible with strong oxidising agents.
11Method of manufacture
Prepared by reacting phenol with ethylene oxide in an alkaline medium (hydroxyethylation of phenol), followed by purification by distillation.
12Safety
At the concentrations used as a preservative it is generally well tolerated on the skin, although irritation and rare contact allergy have been reported. It is an eye irritant in concentrated form, and ingestion of large amounts can cause central nervous system depression.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid contact with the eyes and prolonged skin contact; eye protection and gloves are recommended.
14Regulatory status
Included in the FDA Inactive Ingredient Database (injections, including vaccines, and topical preparations) and in medicines licensed in Europe. Permitted as a preservative in cosmetics in the EU up to 1%.
15Related substances
Benzyl alcohol; phenylethyl alcohol; phenoxypropanol.
16Comments
Phenoxyethanol is particularly active against Gram-negative bacteria, including Pseudomonas aeruginosa, but is weaker against Gram-positive bacteria, yeasts and moulds, which is why it is usually paired with a second preservative. Its activity is little affected by pH over the usual formulation range.