OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to ketorolac (CAS RN 74103-06-3). Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) with antipyretic, analgesic, and anti-inflammatory properties. Ketorolac tromethamine is indicated for the short-term management of moderate to severe acute pain, including pain following major abdominal, orthopedic, and gynecological operative procedures. Clinicians may choose to initiate ketorolac to manage postoperative pain, spinal and soft tissue pain, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, menstrual disorders, and headaches among other ailments. Ketorolac trometamol is used as 0.5% eye drops to relieve ocular itching associated with seasonal allergic conjunctivitis. Ketorolac trometamol eye drops 0.5% have also been used for the topical treatment of cystoid macular edema and for the prevention and reduction of inflammation associated with ocular surgery. In the United States (US), 0.4% or 0.45% eye drops are also available for postoperative ocular inflammation.

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 Ketorolac Tromethamine, just click the ADD TO CART button.

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