Nefopam

Please note, this OEL/ADE monograph also applies to nefopam hydrochloride (CAS RN 23327-57-3). Nefopam is used to relieve acute and chronic pain (for example pain after an operation, dental pain, joint or muscle pain, after an injury, or pain caused by cancer). Nefopam is a centrally acting analgesic with a rapid onset of action. The main site of action appears to be in the central nervous system both at the brain and spinal levels. The mechanism of action is unclear. In vitro experiments have shown nefopam to inhibit the reuptake of various catecholamines (including noradrenaline, serotonin and dopamine). It is possible that the mechanism of action of nefopam is at least in part by altering the levels of these neuromodulators in the brain and at the spinal level. Nefopam has been shown to have sympathomimetic and anticholinergic actions.

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.

Nefopam

CAS Registry Number:
13669-70-0
Brand name:
Acupam®
Cost:
$597 USD

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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), 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. 10-12 pages in length, with calculations and cited references.
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  • Save money. Similar documents cost 5-12 times as much.
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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