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Polyglykol 1000*

Polyethylene glycol, average molar mass 1000 g/mol

Edition Date :
November 29, 2022

Polyglykol 1000 is a pasty PEG excipient grade product, produced under IPEC GMP conditions.

It is specified according to the requirements of the main international ICH guidelines and monographs (see below).

Pharmacopoeia name: USP-NF: Polyethylene glycol 1000, Ph. Eur.: Macrogol 1000

 

* only in combination with a Pharma CoA

Benefits

  • Excellent solubility in water
  • Very low water content
  • Compatible with hard water
  • Non-volatile
  • Outstanding toxicological safety
  • Good biodegradability
Chemical Name
  • Polyethylene glycol, average molar mass 1000 g/mol

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Safety

PEG are non-toxic and physiologically safe so no special safety precautions need to be taken when handling them. For many applications, particularly in pharmaceuticals, cosmetics and foodstuffs packging, the physiological safety of PEG is important. When administered orally and cutaneously they are to be rated as non-toxic. The vapour pressure of PEG is so low that inhalation of relevant amounts is impossible. Because of their good physiological tolerability PEG were first included in the US pharmacopoeia already in 1950. Since then they have been listed in numerous pharmacopoeias. The tolerability of PEG in animals improves as the degree of polymerization rises. PEG have no toxic or irritant effect on the skin. Because of low toxicity it was not possible to establish an exact LD50 resulting from skin penetration.

Ecological Data
The behavior of PEG in effluent is a matter of crucial importance, e.g. in their industrial use in the textile sector and in metal processing. The rate of biodegradation of PEG decreases with increasing molar mass. PEG up to molar mass 1500 are regarded as readily biodegrad able (Zahn-Wellens test). The microbiological degradation of other substances is not inhibited by the presence of PEG. The toxic inhibition limit for bacteria in the fermentation tube test is 5000 mg/l. Investigations within our own labs have shown that even in concentrations of 10000 mg/kg (1%) polyethylene glycols have no adverse effect on fish (crucian carp). Polyethylene glycols in concentration up to 10000 mg/l exhibit no harmful effect of any kind towards daphnia and protozoa. The German water hazard class is WGK 1.

Waste Disposal
Any PEG to be disposed of waste can be taken, in accordance with the local regulations, to a special waste incineration plant. None of PEG, in concentrations up to 10,000 mg/l water, demonstrates an acute harmful effect on fish or bacteria. PEG with molar masses of 200 to 1500 have good biodegradability. It is therefore possible to take them to a biological sewage treatment plant after consulting the operator provided the water and waste regulations permit.

Physical appearance

Paste

Quality status

Excipient, IPEC GMP; Kosher certificate

Application function

Polyglykol 1000 can be used in pharmaceutical as well as cosmetic products. In the pharmaceutical industry it is a preferred base for suppository masses. Numerous actives can be dissolved in PEG 1000 and then have a good bioavailability.


It is also used in the cosmetic industry in toothpastes to improve the consistency and storage stability. In toothpastes it can replace glycerol and sorbitol. PEG 1000 has been proven to be highly successful in the production of transparent toothpastes.

Polyglykol 1000 can also be used in bath oils and foam baths to assist the solubilizing action of the active substances for perfume oils.

It can act as a moisturizer in antiperspirant and deodorants, shampoos and liquid soap, hair styling products and bar soaps.

Solvent, Ointment base

Origin

Germany

Registration

Certificate of Suitability (CEP) available

Technical Data

INCI-PEG 

20

Hazen Colour 25% a.i.in water

max. 30

Molecular Mass [g/mol]

950-1050

OH value [mg koh/g]

107-118

Solidification point [°C]

35-40

Viscosity at 20°C [mPa·s]

50% 24-28

Viscosity at 98.8°C=270°F [mm²/s]

16-19

PH 5% aqueous solution

5.0-7.5

Water content [% M/M]

max. 1

Density at 20°C [g/cm³]

Solidified melt 1.126

Vapour pressure at 20°C [hPa]

< 0.001

Solubility in Water at 20°C [% M/M]

75

Storage

PEG 1000 is stable for 2 years when stored in the original sealed containers in a cool, dry place.

Furthermore the containers should not be exposed to direct sun light. Ambient temperatures for long term storage are preferably between 10°C and 25°C and between 0°C and 30°C as maximum. Storage at higher temperatures is possible only for a short time and should be kept below the solidification point of the products.

The most suitable material for storage tanks is stainless steel, pure aluminium, rubber-or polyethylene lined containers and storage tanks made from glass-fibre-reinforced polyester (GRP). The tank should be ventilated by means of a silica gel dryer. Conventional steel tanks are of limited suitability because after prolonged storage the product may become discoloured owing to traces of iron.

PEG 1000 solidifies when stored in a cool place and must be melted before use. This is best carried out in heating chambers, but the outside temperature should not exceed about 60°C. This must also be ensured when electrical drum heaters are used. Electrical immersion heaters are no suitable for melting owing to the high thermal stress occurring.