OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to alternate CAS RN 1052273-76-3, Polysorbate 40 (CAS RN 9005-66-7), Polysorbate 60 (CAS RN 9005-67-8), Polysorbate 65 (CAS RN 9005-71-4), Polysorbate 65 (CAS RN 9005-71-4), Polysorbate 80 (CAS RN 9005-65-6; 9050-57-1), and Polysorbate 85 (CAS RN 9005-70-3). Polysorbates 80 and 20 (also known as Tween 80 and Tween 20) are used in the formulation of biotherapeutic products both for preventing surface adsorption and as stabilizers against protein aggregation. The polysorbates are amphipathic, nonionic surfactants composed of fatty acid esters of polyoxyethylene sorbitan being polyoxyethylene sorbitan monolaurate for polysorbate 20 and polyoxyethylene sorbitan monooleate for polysorbate 80. Polysorbate 20 is added to water-based cosmetic formulations as the last component required for ensuring that essential oils and fragrance oils remain blended with the bases. Polysorbate 80 is used as an emulsifier, a solubilizer in many foods, including bread, cake mix, salad dressing, shortening oil and chocolate. It is utilized as a surfactant in soaps and cosmetics. In food or pharmaceutical products, it can act as an emulsifier. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration or vaccinations (3). Polysorbate 80 is used to relieve dry, irritated eyes.

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.

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), as well as PIC/S and ANVISA requirements, 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. Over 20 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/ADE monograph for Polysorbates, just click the ADD TO CART button.

HBEL

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