MOLPOL® PEG4000

Polyethylene Glycol 4000

(Binder / Lubricant)

polyethylene-glycol-4000-ep
MOLPOL® PEG4000 is an organic polymer, commonly known as a Polyethylene Glycol 4000. It occurs as white or almost white solid with a waxy or paraffin-like appearance. It is primarily used as a tablet binder, lubricant, plasticizer and ointment/suppository base to improve drug stability, solubility and release

MOLPOL® PEG4000

by Muby Chem

polyethylene-glycol-4000

Polyethylene Glycol 4000

Muby Chem operates a state-of-the-art manufacturing facility that produces Polyethylene Glycol 4000, 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 4000 with exceptional purity and quality, making it an ideal choice for use in the pharmaceutical industry.

Applications: MOLPOL® PEG4000 used as an inactive pharmaceutical excipient in tablets, capsules, ointments, suppositories and coated dosage forms. It acts as a tablet binder and lubricant, improving tablet hardness, reducing friction and enhancing manufacturing efficiency. As a plasticizer, it increases the flexibility of polymer coatings and helps prevent cracking during processing. It also serves as an ointment and suppository base, improving drug stability, solubility and controlled drug release.

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, freely soluble in ethanol (96 %), practically insoluble 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 110 – 170 mPa·s.
7 Freezing point 53 – 59 ℃.
8 Hydroxyl 25 - 32
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® PEG4000 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. It is 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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