MOLSTEAR® PEG

Polyoxyl Stearate

(Surfactant / Emulsifier)

polyoxyl-stearate-usp
MOLSTEAR® PEG is an organic compound widely recognized as Polyoxyl Stearate. It is a nonionic surfactant used in pharmaceutical formulations as an emulsifier, solubilizing agent, wetting agent and dispersing agent.

MOLSTEAR® PEG

by Muby Chem

polyoxyl-stearate-usp-peg

Polyoxyl Stearate

Muby Chem operates a state-of-the-art manufacturing facility producing Polyoxyl Stearate, known for its exceptional purity and performance. This pharmaceutical-grade excipient is widely used in the formulation of oral, topical and liquid pharmaceutical products.

Our advanced manufacturing technology ensures uniform quality and batch-to-batch consistency, making Polyoxyl Stearate suitable for use in a wide range of pharmaceutical applications.

Applications: MOLSTEAR® PEG is extensively employed in pharmaceutical formulations as a nonionic surfactant and oil-in-water emulsifier. It facilitates the solubilization, wetting and uniform dispersion of poorly water-soluble active pharmaceutical ingredients, contributing to improved formulation stability and consistency. It is widely used in tablets, capsules, oral liquids, creams, lotions, ointments, gels and topical emulsions requiring emulsification and solubilization.

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

MOLSTEAR® PEG TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 9004-99-3

SPECIFICATION

#TESTSPECIFICATION - USP
1 Description It occurs as white or slightly yellowish waxy mass.
2 Identification
Test (A)
Test (B)
(A) Infrared Spectroscopy.
(B) It gives test for content of stearic acid and palmitic acid.
3 Solubility It is soluble in alcohol and in isopropyl alcohol.
4 Content Of Free Polyethylene Glycols Between 17.0% to 27.0%.
5 Total Ash Not more than 0.3%.
6 Limit of Ethylene Oxide and Dioxane:
(A) Ethylene Oxide
(B) Dioxane
(A) Not more than 1 ppm.
(B) Not more than 380 ppm.
7 Alkalinity The solution does not turn red.
8 Acid Value Not more than 6.0.
9 Hydroxyl Value Between 25 to 40.
10 Iodine Value Not more than 3.0.
11 Peroxide Value Not more than 10.0
12 Saponification Value Between 25 to 35.
13 Congealing Temperature Between 37°C to 47°C.
14 Water Determination Not more than 3.0%.
15 Melting Range or Temperature Between 37°C to 47°C.
16 Assay
(A) Stearic Acid
(B) Sum of Palmitic and Stearic acids
(A) Not less than 40.0% and not more than 60.0%.
(B) Not less than 90.0%.

PACKAGING

MOLSTEAR® PEG is packed in HDPE bag or HDPE drum with double PE liners inside and is provided with a barcoded label and a tamper-evident seal.

SHELF LIFE, STORAGE AND PACKING

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

ACCREDITATIONS

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

Disclaimer

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