MOLPOL® PEG8000

Polyethylene Glycol 8000

(Lubricant / Binder)

polyethylene-glycol-8000
MOLPOL® PEG8000 is an organic polymer, commonly known as Polyethylene Glycol 8000. It occurs as white or almost white solid with a waxy or paraffin-like appearance. It is used in pharmaceutical formulations as a tablet binder, lubricant, coating agent and solubility enhancer for poorly soluble drugs.

MOLPOL® PEG8000

by Muby Chem

polyethylene-glycol-EP

Polyethylene Glycol 8000

Muby Chem operates a state-of-the-art manufacturing facility that produces Polyethylene Glycol 8000, renowned for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.

Our advanced technology ensures the production of Polyethylene Glycol 8000 with exceptional purity and quality, making it an ideal choice for use in the pharmaceutical industry.

Applications: MOLPOL® PEG8000 is widely used in tablets, capsules, film-coated tablets, creams, ointments, gels, suppositories and controlled-release dosage forms. It functions as a tablet binder and lubricant, improving tablet strength, reducing friction and ensuring smooth manufacturing. As a film-coating plasticizer, it enhances coating flexibility, prevents cracking and improves moisture protection and stability. It also serves as a base for topical and controlled-release formulations.

We follow Good Manufacturing Practices (GMP) and adhere to international regulatory standards to ensure quality consistency with continuous supply.

SPECIFICATION

#TESTSPECIFICATION - EP
1 Appearance It occurs as a white or almost white solid with a waxy or paraffin-like appearance.
2 Solubility It is very soluble in water and in methylene chloride, practically insoluble in ethanol (96%), in fatty oils and in mineral oils.
3 Identification
Test (A)
Test (B)
Test (C)
(A) Viscosity.
(B) An abundant, white, crystalline precipitate is formed.
(C) The liquid phase becomes blue.
4 Appearance of solution The solution is clear and not more intensely coloured than reference solution BY6.
5 Acidity or alkalinity Not more than 0.1 mL of 0.1 M sodium hydroxide is required to
change the colour of the indicator to blue.
6 Viscosity 260 – 510 mPa·s.
7 Freezing point 55 – 62 ℃.
8 Hydroxyl value 12 - 16
9 Reducing substances After 5 min the solution is not more intensely coloured than reference solution R3.
10 Formaldehyde Not more than 30 ppm.
11 Ethylene oxide and dioxan Not more than 1 ppm of ethylene oxide and 10 ppm of dioxan.
12 Water Not more than 1.0%.
13 Sulfated ash Not more than 0.2%.

PACKAGING

MOLPOL® PEG8000 is packed in HDPE bag or HDPE drum with double PE liners inside having bar-coded label and tamper-evident seal.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserved in tight containers.

ACCREDITATIONS

fda
health canada
edqm1
edqm
sgs
ANVISA
sfda
saphra
tga
china
mhra
cdsco
who
eu
exci
ecovadis

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