MOLPOL® PS20

Polysorbate 20

(Solubilizing Agent / Emulsifier)

polysorbate-20-bp
MOLPOL® PS20 commonly known as Polysorbate 20, is an organic compound that enhances the solubility of poorly water-soluble drugs, enabling their incorporation into aqueous formulations.

MOLPOL® PS20

by Muby Chem

polysorbate-20

Polysorbate 20

Muby Chem operates a state-of-the-art manufacturing facility producing Polysorbate 20, known for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.

Our cutting-edge technology ensures the production of high-quality Polysorbate 20, meeting the highest standards for performance and consistency.

Applications: MOLPOL® PS20 is widely used in injectable formulations and oral liquid solutions, where maintaining drug solubility is critical to ensuring therapeutic efficacy and formulation stability.

It also functions as a stabilizer in emulsions and suspensions, preventing oil–water phase separation and inhibiting particle settling, thus ensuring consistent drug delivery.

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

SPECIFICATION

#TESTSPECIFICATION - BP
1 Appearance It occurs as an oily, yellow or brownish-yellow, clear or slightly opalescent liquid.
2 Identification
Test (A)
Test (B)
Test (C)
Test (D)
Test (E)
(A) Infrared absorption spectrophotometry.
(B) Hydroxyl value
(C) Saponification value
(D) Composition of fatty acids
(E) The solution becomes blue.
3 Solubility It is soluble in water, in anhydrous ethanol, in ethyl acetate and in methanol, practically insoluble in fatty oils and in liquid paraffin.
4 Relative density About 1.10
5 Viscosity About 400 mPa·s at 25 °C.
6 Acid value Not more than 2.0.
7 Hydroxyl value Between 96 to 108.
8 Peroxide value Not more than 10.0.
9 Saponification value Between 40 to 50.
10 Composition of fatty acids
(A) Caproic acid
(B) Caprylic acid
(C) Capric acid
(D) Lauric acid
(E) Myristic acid
(F) Palmitic acid
(G) Stearic acid
(H) Oleic acid
(I) Linoleic acid
(A) Not more than 1.0%.
(B) Not more than 10.0%.
(C) Not more than 10.0%.
(D) Not less than 40.0% to not more than 60.0%.
(E) Not less than 14.0% to not more than 25.0%.
(F) Not less than 7.0% to not more than 15.0%.
(G) Not more than 7.0%.
(H) Not more than 11.0%.
(I) Not more than 3.0%.
11 (A) Ethylene oxide
(B) Dioxan
(A) Not more than 1 ppm.
(B) Not more than 10 ppm.
12 Water Not more than 3.0%.
13 Total ash Not more than 0.25%.

PACKAGING

MOLPOL® PS20 is packed in HDPE Drum or IBC packing, having bar coded label.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. It is stored in an airtight container, protected from light.

ACCREDITATIONS

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

Disclaimer

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