Polysorbate 80

Polysorbate 80 is used as a solubilizer, antimicrobial preservative, and as a disinfectant. It is a hydrophilic nonionic surfactant used widely as an additive in foods, pharmaceutical preparations, and cosmetics, as an emulsifier, dispersant, or stabilizer, and as a lubricant in eyedrops. Polysorbate 80 is a primary component in protein formulations and it inhibits potential interfacial damage of the protein molecule that undergoes mechanical stress during shipping and handling. It also affects formulation photostability. When exposed to light, polysorbate 80 in an aqueous solution results in peroxide generation, which may lead to oxidation of the susceptible amino acid residues in the protein molecule.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Polysorbate 80

CAS Registry Number:
9005-65-6
Trade names:
Avitears®, Viva®
Cost:
$639 USD

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Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. 10-12 pages in length, with calculations and cited references.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

How to order

To order an OEL monograph for this compound, just click the ADD TO CART button.

HBEL

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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories