OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Furaltadone hydrochloride (CAS RN 3759-92-0) and Furaltadone tartrate (CAS RN 14343-71-6). Furaltadone is a nitrofuran antibiotic that is effective against bacterial infections in birds when added to feed or drinking water. Furaltadone is also known as 5- (morpholinomethyl)-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone (MNAO). Its use in humans was stopped because of toxicity. Furaltadone had been approved for use in veterinary medicine, but the United Sates (US) Food and Drug Administration (FDA) has since withdrawn approval as a result of evidence of carcinogenicity (3). Furaltadone is indicated topically in some countries in combination with other drugs for the treatment of otitis media and otitis externa.

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 Furaltadone, just click the ADD TO CART button.

HBEL

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