MOLPOL® PEG3350

Polyethylene Glycol 3350

(Osmotic Laxative / Excipient / Binder)

polyethylene-glycol-3350-ep
MOLPOL® PEG3350 is an organic polymer, commonly known as a Polyethylene Glycol 3350. It occurs as a white or almost white solid with a waxy or paraffin-like appearance. It is used widely in pharmaceuticals as an active osmotic laxative ingredient and as an inactive excipient (binder, lubricant and base) in solid, liquid and topical drug formulations.

MOLPOL® PEG3350

by Muby Chem

polyethylene-glycol-3350

Polyethylene Glycol 3350

Muby Chem operates a state-of-the-art manufacturing facility that produces Polyethylene Glycol 3350, 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 3350 with exceptional purity and quality, making it an ideal choice for use in the pharmaceutical industry.

Applications: MOLPOL® PEG3350 is used as an active osmotic laxative in oral powders, solutions, syrups and bowel preparation products to treat constipation. It is also used as an inactive excipient in tablets, capsules, oral liquids, creams, ointments, gels, and suppositories. As an excipient, it functions as a binder, lubricant and base, improving tablet strength, manufacturability, and formulation consistency.

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 83 - 120 mPa·s.
7 Freezing point 53 - 57 ℃.
8 Hydroxyl 30 - 38
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® PEG3350 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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