Lithium Salts

Please note, this OEL/ADE monograph also applies to lithium carbonate (CAS RN 554-13-2), lithium citrate (CAS RN 6080-58-6), and lithium citrate anhydrous (CAS RN 919-16-4). Lithium is a simple alkali metal, the salt of which acts as a mood stabilizing agent which has been extensively used for the treatment of mania for more than 50 years. Lithium carbonate is the carbonate salt of lithium, a soft alkali metal, with antimanic and hematopoietic activities. Lithium interferes with transmembrane sodium exchange in nerve cells by affecting sodium, potassium-stimulated adenosine triphosphatase (Na+, K+-ATPase). It alters the release of neurotransmitters, affects cyclic adenosine monophosphate (cAMP) concentrations and blocks inositol metabolism resulting in depletion of cellular inositol and inhibition of phospholipase C-mediated signal transduction. Lithium citrate is the citrate salt of lithium, a monovalent cation with antimanic activity. Lithium, in its salt forms, is used as a mood stabilizer and for the treatment of depression and mania. It is most frequently prescribed in the treatment of bipolar disorder.

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.

Lithium Salts

CAS Registry Number:
17341-24-1
Trade names:
Carbolith®, Eskalith®
Cost:
$639 USD

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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. 10-12 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 Lithium Salts, just click the ADD TO CART button.

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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.
  • K. Rosenthal
  • Director of Manufacturing