Polyglykol 400 is a liquid 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).
* only in combination with a Pharma CoA
- Good solubility in water
- Very low water content
- Compatible with hard water
- Outstanding toxicological safety
- Good biodegradability
- Polyethylene glycol, average molar mass 400 g/mol
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 packaging, 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.
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 biodegradable (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.
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.
PEG 400 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.
It is essential to ensure storage in a dry place because liquid PEG are hygroscopic. Each time the containers are opened, they should be resealed to make them airtight. Even with sealed laboratory containers it is impossible to prevent atmospheric oxygen and moisture acting on PEG 400 owing to frequent opening. We therefore recommend that laboratory samples should also not be stored longer than 2 years.
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.
The recommended method of storing PEG 400 is in stainless steel or aluminium containers fitted with an external, heating coil. The storage temperature should not exceed 70°C, and it is advisable to thoroughly mix the contents of the storage container with a dry nitrogen stream or a circulating pump.
USP-NF: Polyethylene glycol 400, J.P.: Macrogol 400,
Ph. Eur.: Macrogol 400
Excipient, IPEC GMP; Kosher certificate
Solvent, Humectant, Coating agent, Viscosity Enhancer
Polyglykol 400 can be used in liquid pharmaceutical preparations such as drops or fillings for gelatin capsules. It can also be used in ointment mixtures for example in combination with Polyglykol 3350.
Polyglykol 400 is listed as active ingredient in ophthalmic demulcents.
Polyglykol 400 is recommended as a moisturizer in creams and all preparations that tend to dry out. It also acts as a cleansing agent in face lotions and as non-greasy lubricant and perfume stabilizer in after-shave lotions.
It can be used in lipsticks as solubilizers for tetrabromofluorescein and its derivatives and in hair care products where improves the consistency of non-greasy hair care porducts which can be whased out with clear water. Polyglykol 400 is also used in hair styling products as a plasticizer and anti-static agent. It counteracts the tendency of these products to dry to a brittle film.
It is also used in toothpastes where it improves consistency and storage stability.
Polyglykol 400 can also be used in bath oils and foam baths to assist the solubilizing action of the active substances for perfume oils.
Certificate of Suitability (CEP) available
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