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transcutol [solvent]
Chemical name : Diethylene glycol monoethyl ether
English name : Diethylene glycol monoethyl ether
Application :
Solvents for many active drugs (such as: nitroglycerin, indomethacin, nifedipine, hormones, sterols);
Absorption enhancer;
It can be used for local administration, transdermal administration and preparation of oral preparations;
Can be combined with LABRAFIL ? series of auxiliary materials and vegetable oil
Appearance : colorless transparent liquid
Solubility at 20°C (European Pharmacopoeia third edition):
96% alcohol soluble
Soluble in water
Partially soluble in vegetable oil
Insoluble in mineral oil
Volatile compounds and organic solvents:
In TRANSCUTOL ? Related to residual solvent is less than the limits specified in ICH
Related organic solvents and limits in ICH:
-2-Methoxyethanol: <50ppm
-2-Ethoxyethanol: <160ppm
-Ethylene glycol: <620ppm
Toxicology :
-Acute oral toxicity (rat): LD 50 >5000mg/kg
-Reversible eye irritation (100%): No irritation
-Eye irritation (30%): No irritation
-Basic skin irritation (rabbit-50%/water): no irritation
-Basic skin irritation (human -100%): no irritation
-Skin sensitivity (100%): No sensitivity
-28-day repetitive skin toxicity (rabbit): up to a non-toxic dose of 1000mg/kg/day
Regulatory status : (1) USP-NF/EP/IIG
(2) Documents are being prepared and IDL will be applied soon
Packing : 25kg/drum, 200kg/drum
Storage : Store in a cool and dry place, avoid exposure to air
Supplier: Jiafa Shi
Contact: Manager Liu
Contact number: 139 1173 0390
E-mail: eileenliu@gattefossecn.