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Excipient monograph · مونوگراف ماده جانبی
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Thymol
تیمول
1Nonproprietary names
- BPThymol
- Ph. Eur.Thymol
- USP–NFThymol
2Synonyms and trade names
Thyme camphor; m-thymol; isopropyl-m-cresol; 2-isopropyl-5-methylphenol; thymolum
3Chemical name and CAS Registry Number
5-Methyl-2-(1-methylethyl)phenol · [89-83-8]
UNII 3J50XA376E · PubChem CID 6989
4Empirical formula and molecular weight
C10H14O · 150.22
5Functional category
Antimicrobial preservative, Flavouring agent
Typical concentrations: — · Dosage forms: Liquid
6Applications in pharmaceutical formulation
Used as an antimicrobial and flavouring agent in mouthwashes, gargles and toothpastes, and as a stabiliser (antioxidant) in halothane at about 0.01% w/w. It is also included in some topical antiseptic and antifungal preparations and in cosmetics and perfumes.
7Description
Colourless, often large crystals or a white crystalline powder with an aromatic, thyme-like odour and a pungent, burning taste. It is the main phenolic component of thyme oil.
8Typical properties
- Melting point
- 48–52 °C
- Boiling point
- about 232 °C
- Solubility
- very slightly soluble in water (about 1 in 1000); very soluble in ethanol (95%); freely soluble in ether, chloroform and fixed and volatile oils
- Volatility
- volatile at room temperature and readily steam-distilled
9Stability and storage conditions
Stable but volatile, and may discolour on exposure to light and air. Store in a well-closed, light-resistant container in a cool place.
10Incompatibilities
Forms liquid eutectic mixtures when triturated with camphor, menthol, phenol, phenyl salicylate and some other compounds. Incompatible with strong oxidising agents; as a phenol it may discolour with iron salts.
11Method of manufacture
Obtained from thyme oil and other essential oils, or prepared synthetically, for example by alkylation of m-cresol with propene.
12Safety
At the low levels used as an excipient it is generally well tolerated. Concentrated thymol irritates the skin and mucous membranes, may cause contact sensitisation, and is toxic if swallowed in large amounts.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid skin and eye contact and inhalation of the vapour; gloves and eye protection are recommended.
14Regulatory status
Permitted in the USA as a synthetic flavouring substance in foods. Used in oral-care and topical products licensed in Europe and elsewhere.
15Related substances
Carvacrol; chlorocresol; cresol; menthol; phenol.
16Comments
Thymol is often used together with menthol, eucalyptol and methyl salicylate in antiseptic mouthwashes. Its low water solubility means that an alcohol or a surfactant is usually needed in aqueous products.