MOLPOL® PEG3350

Polyethylene Glycol 3350

(Osmotic Laxative / Binder / Lubricant)

polyethylene-glycol-3350-usp
MOLPOL® PEG3350 is an organic polymer, commonly known as a Polyethylene Glycol 3350. It occurs as a white granular, powder or flakes. 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 and cleanse the bowel. 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 - USP
1 Description It occurs as white granular, powder or flakes.
2 Solubility It is freely soluble in water; soluble in acetone, in alcohol, in chloroform, in ethylene glycol monoethyl ether, in ethyl acetate, and in toluene; insoluble in ether and in hexane.
3 Identification
Test (A)
Test (B)		 (A)Infrared Spectroscopy.
(B)Chromatographic Identity.
4 Residue On Ignition Not more than 0.1%.
5 Limit Of Ethylene Oxide and Dioxane
(A) Ethylene oxide
(B) Dioxane
(A) Not more than 1 μg/g.
(B) Not more than 10 μg/g.
6 Limit Of Ethylene Glycol
(A) Ethylene glycol
(B) Sum of diethylene glycol and ethylene glycol
(A) Not more than 0.062%.
(B) Not more than 0.2%.
7 Limit Of Formaldehyde and Acetaldehyde
(A) Formaldehyde
(B) Sum of formaldehyde and acetaldehyde

(A)Not more than 30 μg/g.
(B) Not more than 200 μg/g.
8 Apparent Weight-Average Molecular Weight And
Polydispersity		 The value of apparent weight-average molecular weight is 3015–3685 g/mol. Polydispersity is 90%–110% of the value stated on the label or within the range indicated on the label.
9 Hydroxyl Value 30–38
10 Acidity And Alkalinity 4.5–7.5
11 Water Determination Not more than 1.0%
12 Assay Not more than 97.0% and not less than 103.0% on the anhydrous basis.

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. Preserve in tight containers, protected from direct sunlight. Avoid exposure to excessive heat.

ACCREDITATIONS

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

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