(Binder / Lubricant)
by Muby Chem
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.
| # | TEST | SPECIFICATION - USP |
|---|---|---|
| 1 | Description | It occurs as white, waxy, plastic material having a consistency similar to beeswax, or as creamy white flakes, beads, or powders. |
| 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 | Residue On Ignition | Not more than 0.1%. |
| 4 | Limit of Free ethylene oxide and 1,4-Dioxane | NMT 10 μg/g of ethylene oxide and NMT 10 μg/g of 1,4-dioxane. |
| 5 | pH | 4.5 – 7.5 |
| 6 | Completeness And Color of Solution | Not more than slightly hazy. |
| 7 | Viscosity | 110–158 |
| 8 | Assay (A) Average Molecular Weight. |
(A) Not less than 90.0% and not more than 110.0%. |
MOLPOL® PEG4000 is packed in HDPE bag or HDPE drum with double PE liners inside having bar-coded label and tamper-evident seal
The shelf life is 3 years. It is preserved in tight containers.
This document and any information provided herein does not constitute a legally binding obligation of Muby Chem and has been prepared in good faith and is believed to be accurate as of the date of issuance. Unless expressly agreed otherwise in writing in a supply contract or other written agreement between you and Muby Chem: