OEL Fastrac Catalog

Sodium zirconium cyclosilicate, also known as ZS-9, is indicated for the treatment of hyperkalemia in adult patients. ZS-9 is a non-absorbed, non-polymer, inorganic powder that has the ability to exchange potassium for sodium cations contained in its uniform microporous crystalline structure. It captures potassium throughout the entire GI tract and reduces the concentration of free potassium in the GI lumen, leading to an increase in fecal excretion, eventually leading to lowered serum potassium and resolution of hyperkalemia. Its high affinity for potassium ions is not influenced by the presence of other cations such as calcium and magnesium.

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 Sodium Zirconium Cyclosilicate, just click the ADD TO CART button.

HBEL

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