OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Citicoline sodium (CAS RN 33818-15-4). Citicoline (also known as cytidine diphosphate choline and citicholine) is an endogenous intermediate in the formation of phosphatidylcholine from choline which is thought to have neuroprotective effects. Citicoline is a derivative of choline and cytidine that is involved in the biosynthesis of lecithin. Citicoline is indicated for the treatment, supportive care, or diagnosis of mania, hypomania, cocaine abuse, bipolar disorder, and glaucoma. It is claimed to increase blood flow and oxygen consumption in the brain and has been given in the treatment of cerebrovascular disorders (including ischemic stroke), parkinsonism, and head injury. Citicoline is also used in food supplements. Citicoline is available in Japan, Spain, France, and Italy as a pharmaceutical product. In the United States (US), citicoline is available as a component of supplement products.

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 Citicoline, just click the ADD TO CART button.

HBEL

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