Please note, this OEL/ADE monograph also applies to Citicoline sodium (CAS RN 33818-15-4). Citicoline is choline cytidine 5-pyrophosphate. It is a naturally occurring intermediate that is broken down to produce cytidine and choline; all three occur naturally in the body. Citicoline is approved as a novel food ingredient. Choline is a water-soluble essential nutrient involved in structural, metabolic, physiological and neurological functions. Cytidine is a constituent of RNA and is found in foods.
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.
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:
To order an OEL/ADE monograph for Citicoline, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’ 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.