ROKwinol 20PF

Manufacturer
PCC Exol SA
Chemical name
Polysorbatum 20
CAS No.
9005-64-5
INCI
Polysorbate 20
Good manufacturing practice EFfCI Good manufacturing practice EFfCI ISO 14001 ISO 14001 ISO 9001 ISO 9001 Pharmaceutical quality Pharmaceutical quality New New ISO 45001 ISO 45001 Safe product Safe product
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ROKwinol 20PF is a monolaurynian sorbitan ester ethoxylated by approximately 20 moles of ethylene oxide. The product contains 99% of active substance. 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

Function
Emulsifiers

Composition
Sorbitan esters

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

Alternative names
Polysorbatum 20, Polysorbate 20
Regulatory status
ROKwinol 20PF meets the requirements of the current Ph. Eur. monograph Polysorbate 20
About the producer