OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to maropitant citrate (CAS RN 359875-09-5) and Maropitant citrate anhydrous (CAS RN 862543-54-2). Maropitant, a neurokinin (NK1) receptor antagonist, is indicated for use in the treatment of motion sickness and vomiting in dogs and cats. Maropitant is a veterinary drug and is not indicated for use in humans. Maropitant citrate is a neurokinin (NK1) receptor antagonist that also has anti-nociceptive (analgesic) properties. Maropitant inhibits binding of substance P, a neuropeptide of the tachykinin family to NK-1 receptors, in the central nervous system. Substance P is found in significant concentrations in the nuclei comprising the emetic center and is considered a key neurotransmitter involved in emesis. By inhibiting the binding of substance P within the emetic center, maropitant provides broad-spectrum effectiveness against neural (central) and humoral (peripheral) causes of vomiting.

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 Maropitant, just click the ADD TO CART button.

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