OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to donepezil hyrochloride (CAS RN 120011-70-3) donepezil hydrochloride monohydrate (CAS RN 884740-09-4), and donepezil oxalate (CAS RN 870555-76-3). Additionally, this monograph contains the pediatric ADE (pADE). Donepezil is a piperidine derivative acetylcholinesterase (AChE) inhibitor for the management of mild, moderate, and severe Alzheimer’s disease. When combined with memantine, the extended-release form of donepezil is indicated to treat the symptoms of moderate to severe dementia of the Alzheimer’s type and for suppression of progression of dementia symptoms in Alzheimer disease and in Lewy body dementia. In some countries, donepezil is also licensed for use in patients with vascular dementia. Donepezil is a racemate comprising equimolar amounts of (R)-donepezil and (S)- donepezil.

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 Donepezil, just click the ADD TO CART button.

HBEL

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