ROKwinol 20PF (Polysorbate 20)

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Manufacturer
PCC Exol SA
Chemical name
Sorbitan monolaurate, ethoxylated
CAS No.
INCI
Polysorbate 20
Good manufacturing practice EFfCI Good manufacturing practice EFfCI Greenline® products Greenline® products High efficiency High efficiency High pure High pure ISO 14001 ISO 14001 ISO 50001 ISO 50001 ISO 9001 ISO 9001 Pharmaceutical quality Pharmaceutical quality Not classified according to CLP/GHS Regulation Not classified according to CLP/GHS Regulation New New ISO 45001 ISO 45001 Safe product Safe product Biodegradable product Biodegradable product
                                
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ROKwinol 20PF is a monolaurynian sorbitan ester ethoxylated by approximately 20 moles of ethylene oxide. Finally chemical parameters of ROKwinol 20PF are in line with current monograph of European Pharmacopeia for Polysorbate 20. Among others product meets strict limits for low content of ethylene oxide, dioxane or heavy metals.

Appears in the form of oily, clear liquid with yellow to light brownish color. It is characterized by very good solubility in water and polar solvents like: anhydrous ethanol, ethyl acetate or methanol. Product is practically insoluble in fatty oil and liquid paraffin.

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Properties and applications

Product advantages:

  • meets the restricted quality parameters defined by European Pharmacopoeia,
  • low level of ethylene oxide, 1,4 – dioxane, heavy metals,
  • excellent emulsification properties,
  • good dispersing and stabilizing agent,
  • chemical equivalent for Polysorbate 20 – substance approved by FDA as Inactive Ingredient for Approved Drug Product.

Applications:

  • eye/ear drops,
  • tablets,
  • capsules,
  • ointments and creams,
  • suppositories,
  • aerozols.
Categories

Markets and applications
Pharmaceuticals / Excipients for drug formulations

Function
Dispersants
Emulsifiers

Composition
Sorbitan esters

Segment
Specialty Products / Specialty additives
Surfactants / Non-ionic surfactants

Alternative names
Sorbitan monolaurate, ethoxylated, Sorbitan, monododecanoate, poly(oxy-1, 2-ethanediyl) derivs., Polyoxyethylene sorbitanmonolaurate, Ethoxylated sorbitan monolaurate (Ph. Eur.), POLYSORBATE 20.
Regulatory status
ROKwinol 20PF meets the requirements of the current Ph. Eur. monograph Polysorbate 20
Manufacturer: PCC Exol SA

PCC EXOL SA is one of the most important manufacturers of surfactants and chemical formulations in Central and Eastern Europe. The company offers surfactants, specialist additives and chemical formulations for many branches of industry.

PCC Group

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