OEL Fastrac Catalog

Nitrofurazone, also known as nitrofural, is a synthetic furan derivative, active against a broad spectrum of bacteria, which has been widely used in veterinary and human medicine. Nitrofurazone is a topical anti-infective agent effective against gram-negative and grampositive bacteria. It is used for superficial wounds, injuries and skin infections. Nitrofurazone is used as an antibacterial preparation for topical application in cats, dogs and horses. Nitrofurazone has also been administered orally in the treatment of trypanosomiasis. It is also used for treatment of bacterial skin infections including pyodermas, infected dermatoses and infections of cuts, wounds, burns and ulcers due to susceptible organisms. Nitrofurazone ointment is a water-soluble antibacterial ointment for the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers. Nitrofurazone nasal solution has been used in the treatment of nasal infections.

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 Nitrofurazone, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.