Butenafine Hydrochloride

Butenafine hydrochloride is an antifungal, over the counter drug (OTC) indicated for topical treatment of several dermatologic infections including tinea (pityriasis) versicolor due to M. furfur, athlete’s foot, ringworm and jock itch due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans, respectively. Butenafine hydrochloride mechanism of action has not been fully established; however, it has been suggested that butenafine interferes with sterol biosynthesis, particularly ergosterol, by inhibiting squalene monooxygenase, an enzyme responsible for converting squalene to 2,3-oxydo squalene. Ergosterol is an essential component of the fungal cell membrane and inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Blockage of squalene monooxygenase also leads to a subsequent accumulation of squalene. When a high concentration of squalene is reached, it is thought to have fungicidal activity, directly killing fungal cells.

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.

Butenafine Hydrochloride

CAS Registry Number:
101827-46-7
Trade names:
Lotrimin Ultra®, Mentax®, Tinactin®
Cost:
$639 USD

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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), 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. 10-12 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.

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To order an OEL monograph for this compound, just click the ADD TO CART button.

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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories