Bromfenac

Please note, this monograph also contains the ocular ADE. Additionally, this OEL/ADE monograph also applies to Bromfenac sodium (CAS RN 91714-93-1) and Bromfenac sodium sesquihydrate (CAS RN 120638-55-3). Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. It is used in the management of ocular pain and inflammation. Their well-characterized antiinflammatory activity, analgesic property, and established safety record have also made NSAIDs an important tool to optimize surgical outcomes. Bromfenac is used in the treatment of postoperative inflammation in patients who have undergone cataract extraction surgery.

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.

Bromfenac

CAS Registry Number:
91714-94-2
Brand names:
Bromday , BromSite , Prolensa , Xibrom , Yellox 
Cost:
$679 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), 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. 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.

How to order

To order an OEL/ADE monograph for Bromfenac, just click the ADD TO CART button.

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Affygility Solutions’ 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