MOLPOL® PS80

Polysorbate 80

(Surfactant / Emulsifier / Stabilizer)

polysorbate-80-ep
MOLPOL® PS80 an organic compound also known as Polysorbate 80. It occurs as an oily, colourless or brownish-yellow, clear or slightly opalescent liquid. It is a nonionic surfactant, emulsifier to improve emulsification, solubilization, wetting, and formulation stability.

MOLPOL® PS80

by Muby Chem

polysorbate-80

Polysorbate 80

Muby Chem operates a state-of-the-art manufacturing facility that produces Polysorbate 80, renowned for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.

Our advanced technology ensures the production of Polysorbate 80 with exceptional purity and quality, making it an ideal choice for use in the pharmaceutical industry.

Applications: MOLPOL® PS80 is used in pharmaceutical formulations. It helps mix oil and water, improves the solubility of poorly water-soluble drugs and enhances formulation stability. It is used in injectable formulations, vaccines, oral liquids, ophthalmic preparations, topical creams, lotions, emulsions and gels. MOLPOL® PS80 also protects proteins, peptides, vaccines and other biologics from aggregation and adsorption during storage and transport.

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 oily, colourless or brownish-yellow, clear or slightly opalescent liquid.
2 Solubility It is dispersible in water, in anhydrous ethanol, in ethyl acetate and in methanol, practically insoluble in fatty oils and in liquid paraffin.
3 Relative density About 1.10.
4 Viscosity About 400 mPa·s.
5 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.
6 Acid value Not more than 2.0.
7 Hydroxyl value 65 to 80.
8 Peroxide value Not more than 10.0.
9 Saponification value 45 to 55
10 Composition of fatty acids
(A) Myristic acid
(B) Palmitic acid
(C) Palmitoleic acid
(D) Stearic acid
(E) Oleic acid
(F) Linoleic acid
(G) Linolenic acid
(A) Not more than 5.0 %.
(B) Not more than 16.0%.
(C) Not more than 8.0%.
(D) Not more than 6.0%.
(E) Not less than 58.0%.
(F) Not more than 18.0%.
(G) Not more than 4.0%.
11 Ethylene oxide and dioxan Not more than 1 ppm of ethylene oxide and 10 ppm of dioxan.
12 Water Not more than 3.0%.
13 Total ash Not more than 0.25%.

PACKAGING

MOLPOL® PS80 is packed in HDPE drum or IBC packing having bar-coded label.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Store 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

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