OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to cinitapride tartrate (CAS RN 1207859-16-2/96623-56-2). Cinitapride is a prokinetic agent in the gastrointestinal tract and an antiulcer agent indicated for use in the treatment of gastrointestinal disorders associated with motility disturbances such as gastroesophageal reflux disease, non-ulcer dyspepsia, and delayed gastric emptying. Cinitapride is a substituted benzamide that acts as an agonist of the 5-HT1 and 5-HT4 receptors and as an antagonist of the 5-HT2 receptors (2). It blocks the presynaptic serotonin receptors and increases its release, resulting in greater serotonergic activity. Cinitapride also has discrete antidopaminergic activity, which adds to its therapeutic effect (4). It activates the myenteric nerve plexus and promotes the release of acetylcholine which favors propulsive movement in the GI tract. This activity promotes quick expulsion of gastric contents from the stomach into the small intestine, thereby improving symptoms of dyspepsia.

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 Cinitapride, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.