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Excipient monograph · مونوگراف ماده جانبی
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Diethylene glycol monoethyl ether
ترانسکوتول
1Nonproprietary names
- BPDiethylene Glycol Monoethyl Ether
- Ph. Eur.Diethylene Glycol Monoethyl Ether
- USP–NFDiethylene Glycol Monoethyl Ether
2Synonyms and trade names
carbitol; DEGEE; diethylene glycol ethyl ether; 2-(2-ethoxyethoxy)ethanol; ethoxydiglycol; Transcutol; Transcutol P; Transcutol HP
3Chemical name and CAS Registry Number
2-(2-Ethoxyethoxy)ethanol · [111-90-0]
UNII A1A1I8X02B · PubChem CID 8146
4Empirical formula and molecular weight
C6H14O3 · 134.17
5Functional category
Solvent, humectant, Penetration enhancer
Typical concentrations: — · Dosage forms: Semi-solid
6Applications in pharmaceutical formulation
Used as a solvent, cosolvent and skin penetration enhancer in topical and transdermal gels, creams and solutions, often at about 5–30% w/w, and as a cosolvent in oral liquids and lipid-based (self-emulsifying) formulations. It increases the solubility of many poorly water-soluble drugs and can increase their retention in the skin. It is also used in cosmetics.
7Description
A clear, colourless, hygroscopic liquid with a slight, pleasant odour. High-purity pharmaceutical grades are controlled for ethylene glycol, diethylene glycol and peroxides.
8Typical properties
- Boiling point
- about 196–202 °C
- Density
- about 0.99 g/cm³ at 20 °C
- Refractive index
- about 1.427
- Solubility
- miscible with water, ethanol, acetone, propylene glycol and polyethylene glycols; partly miscible with vegetable oils; immiscible with mineral oil
9Stability and storage conditions
Hygroscopic, and it can form peroxides on exposure to air. Store in an airtight container, preferably under nitrogen, protected from light, in a cool place.
10Incompatibilities
Incompatible with strong oxidising agents. Peroxides formed on storage can degrade oxidation-sensitive drugs.
11Method of manufacture
Made by reacting ethylene oxide with ethanol, followed by fractional distillation; pharmaceutical grades undergo further purification to remove glycol impurities.
12Safety
High-purity grades have low toxicity and are well tolerated on the skin, with little irritation or sensitisation. Lower-purity material may contain ethylene glycol and diethylene glycol, which are toxic to the kidneys, so only pharmaceutical grades meeting pharmacopoeial limits should be used.
13Handling precautions
Observe normal precautions for the quantity handled. Wear eye protection and gloves and use in a well-ventilated area.
14Regulatory status
Included in the FDA Inactive Ingredient Database (topical and transdermal preparations) and in topical medicines licensed in Europe.
15Related substances
Diethylene glycol; glycofurol; propylene glycol; polyethylene glycol.
16Comments
Given the history of poisonings caused by diethylene glycol contamination of glycol-type excipients, suppliers must be qualified and each batch tested for ethylene glycol and diethylene glycol as the pharmacopoeias require. Because it is hygroscopic and volatile only to a limited extent, products may change weight on open storage.