OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to the following CAS RN 175591-09-0 (hydrochloride), Tapentadol phosphate (CAS RN 1356394-30-3),Tapentadol hydrobromide (CAS RN 1356475-57-4) and Tapentadol maleate (CAS RN 1443156-37-3; 1356394-87-0). Tapentadol is a centrally-acting synthetic analgesic. Immediate-release tapentadol is indicated for the management of moderate to severe acute pain in adults. Extendedrelease tapentadol is indicated for the management of pain that is opioid-responsive and severe enough to require daily, continuous, long-term opioid treatment, and for which alternative treatment options are inadequate. Extended-release tapentadol is also indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that is severe enough to require daily, around-the-clock, longterm opioid treatment and for which alternative treatment options are inadequate.

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 Tapentadol, just click the ADD TO CART button.

HBEL

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