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Commission Directive 2008/84/EC (repealed)Dangos y teitl llawn

Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) (Codified version) (repealed)

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Changes over time for: E 1521 POLYETHYLENE GLYCOLS

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[F1E 1521 POLYETHYLENE GLYCOLS U.K.

Synonyms PEG, Macrogol, Polyethylene oxide
Definition Addition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the molecular weight
Chemical name alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol)
Chemical formula HOCH 2 - (CH 2 - O - CH 2 ) n - CH 2 OH
Average molecular weight 380 to 9 000 D
Assay

PEG 400: Not less than 95 % and not more than 105 %

PEG 3000: Not less than 90 % and not more than 110 %

PEG 3350: Not less than 90 % and not more than 110 %

PEG 4000: Not less than 90 % and not more than 110 %

PEG 6000: Not less than 90 % and not more than 110 %

PEG 8000: Not less than 87,5 % and not more than 112,5 %

Description

PEG 400 is a clear, viscous, colourless or almost colourless hygroscopic liquid

PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are white or almost white solids with a waxy or paraffin-like appearance

Identification
Melting point

PEG 400: 4-8 °C

PEG 3000: 50-56 °C

PEG 3350: 53-57 °C

PEG 4000: 53-59 °C

PEG 6000: 55-61 °C

PEG 8000: 55-62 °C

Viscosity

PEG 400: 105 to 130 mPa.s at 20 °C

PEG 3000: 75 to 100 mPa.s at 20 °C

PEG 3350: 83 to 120 mPa.s at 20 °C

PEG 4000: 110 to 170 mPa.s at 20 °C

PEG 6000: 200 to 270 mPa.s at 20 °C

PEG 8000: 260 to 510 mPa.s at 20 °C

For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in water

Solubility

PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils

PEG 3000 and PEG 3350: very soluble in water and in methylene chloride, very slightly soluble in alcohol, practically insoluble in fatty oils and in mineral oils

PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils

Purity
Acidity or alkalinity Dissolve 5,0 g in 50 ml of carbon dioxide-free water and add 0,15 ml of bromothymol blue solution . The solution is yellow or green. Not more than 0,1 ml of 0,1 M sodium hydroxide is required to change the colour of the indicator to blue
Hydroxyl value

PEG 400: 264-300

PEG 3000: 34-42

PEG 3350: 30-38

PEG 4000: 25-32

PEG 6000: 16-22

PEG 8000: 12-16

Sulphated ash Not more than 0,2 %
1,4-Dioxane Not more than 10 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycol and diethylene glycol Total not more than 0,25 % w/w individually or in combination
Lead Not more than 1 mg/kg]

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