Chemical name:

Polysorbatum 20

Regulatory status:

ROKwinol 20PF meets the requirements of the current Ph. Eur. monograph Polysorbate 20

Segment:

specialty products, specialty additives, surfactants, non-ionic surfactants

Markets and applications:

pharmaceuticals

Function:

emulsifiers

Composition:

sorbitan esters

Manufacturer:

PCC Exol SA

CAS No.:

9005-64-5

INCI:

Polysorbate 20

Description

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.

Production of ROKwinol 20PF includes three stages where third one is the post treatment process aimed at removing undesirable by-products and contaminants. 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.

ROKwinol 20PF is a non-ionic emulsifier for O/W type of emulsion, is applied to final drug dosage form in order to provide suitable consistency of formulation. It’s responsible for appropriate emulsification of oily additives, vitamins, active substances. Polysorbate 20 in pharmaceutical formulation is used also as binding agent, base or diluent for pills and tablets. Additionally it is used as wetting agent in flavored mount drops helping to spread other ingredients.

ROKwinol 20PF is approved by FDA as Inactive Ingredient for Approved Drug Products such as invectives, suspensions, capsules, tablets, eye/ear drops, aerosol foams, suppositories. 

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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.

Alternative names:

Show alternative names
Polysorbate 20 (Hide)

Tags:

ph eur pure safe product pharmaceutical eur. ph. excipient pharma grade pharmacopoeia excipients API dermocosmetics ointments medicines auxiliary humectants active ingredients binding agents emolients cosmetics polysorbate 20 emulsifier
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