OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to lefamulin acetate (CAS RN 1350636-82-6). Lefamulin is a recently developed semi-synthetic pleuromutilin antibiotic derived from the fungus Pleurotus mutilus. Lefamulin is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. Lefamulin is a systemic pleuromutilin antibacterial. It inhibits bacterial protein synthesis through interaction with the A- and P-sites of the peptidyl transferase center (PTC) in domain V of the 23s rRNA of the 50S subunit. The binding pocket of the bacterial ribosome closes around the mutilin core for an induced fit that prevents correct positioning of tRNA. Because of its mechanism of action that differs from that of other antimicrobials, crossresistance to other antibiotic classes is less likely.

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 Lefamulin, just click the ADD TO CART button.

HBEL

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