OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to alternate CAS RN 2709-56-0, flupentixol dihydrochloride (CAS RN 2413-38-9; 51529-01-2), and Flupentixol decanoate (CAS RN 30909-51-4; 201213-08-3). Flupentixol decanoate is a typical antipsychotic of the thioxanthene class. Flupentixol is indicated for the maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation or hyperactivity. Flupentixol is a thioxanthene derivative with antipsychotic properties. The exact mechanism of action of flupentixol has not been established. Its effects resemble those of the phenothiazine fluphenazine, in that it belongs among the antipsychotic drugs which are less likely to cause sedation and hypotension but have greater propensity for producing extrapyramidal reactions. Its primary pharmacological action is dopamine blockade. Flupentixol has a high affinity for D1 and D2 receptors.

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 Flupentixol, just click the ADD TO CART button.

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