Phenytoin sodium is often administered as its sodium salt and has been widely used as an anticonvulsant in the treatment of epilepsy, to a lesser extent and more recently, in the treatment of certain cardiac arrhythmias. The primary site of action appears to be the motor cortex where the spread of the seizure activity is inhibited. Possibly by promoting sodium efflux from neurons, Phenytoin tends to stabilize the threshold against hyper excitability caused by excessive stimulation or environmental changes capable of reducing the membrane sodium gradient. This includes the reduction of posttetanic potentiation at synapses. Loss of posttetanic potentiation prevents cortical seizure foci from detonating adjacent cortical areas. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).
Why do you need this OEL Fastrac monograph?
OEL Fastrac monographs are a cost-effective and convenient way 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
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- $595 USD
OEL Fastrac is an innovative way to obtain occupational exposure limit monographs for active pharmaceutical ingredients. It's super convenient and affordable, and the quality is outstanding.
- K. Tarwater
- EHS Manager
- Catalent Pharma Solutions
Affygility Solutions’s 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
- Pharmatek Laboratories