OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to potassium sorbate (CAS RN 590-00), alternate (CAS RN 24634-61-5), and sorbate ion (CAS RN 72138-88-6). Sorbic acid is a straight-chain monocarboxylic acid also known as 2,4-hexadienoic acid. Potassium sorbate is the potassium salt of sorbic acid. Sorbic acid occurs naturally as the lactone, parasorbic acid, in berries of the mountain ash, Sorbus aucuparia L., in the family Rosaceae and can be synthesized by various processes. Sorbic acid and potassium sorbate are used in cosmetics and toiletries as preservatives and antimicrobials. Sorbic acid and potassium sorbate are effective preservatives at low concentration for the control of mold and yeast in cheese products, baked goods, fruit juices, fresh fruits and vegetables, wines, soft drinks, pickles, sauerkraut, and certain fish and meat products. Sorbic acid and potassium sorbate are also used as preservatives in a variety of pharmaceuticals.

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 Sorbic Acid, just click the ADD TO CART button.

HBEL

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