OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to phenytoin sodium (CAS RN 630-93-3) and phenytoin calcium (CAS RN 17199-74-5). Phenytoin, also known as 5,5-diphenylhydantoin and diphenylhydantoin, is a hydantoin antiepileptic used to control partial and generalized tonic-clonic seizures. It is also used as part of the emergency treatment of status epilepticus and has been used for the prevention and treatment of seizures associated with neurosurgery or severe traumatic injury to the head. Phenytoin has also been used in the treatment of trigeminal neuralgia. It is also a class Ib antiarrhythmic and has been used to treat cardiac arrhythmias. A combination of pentobarbital sodium and phenytoin sodium is used in dogs for humane, painless, and rapid euthanasia. Phenytoin is available as capsules, extended-release capsules, suspension, and tablets for oral administration. It is also available as a solution and liquid for intramuscular (IM) or intravenous (IV) administration.

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 Phenytoin, just click the ADD TO CART button.

HBEL

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