OEL Fastrac Catalog

Tolvaptan is indicated for slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). It is used to treat low sodium levels in the blood. Low blood sodium levels (hyponatremia) can be associated with various conditions like congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormones (SIADH). Tolvaptan is a selective vasopressin V 2-receptor antagonist with an affinity for the V 2- receptor that is 1.8 times that of native arginine vasopressin (AVP). Tolvaptan affinity for the V 2-receptor is 29 times that for the V 1a-receptor. Decreased binding of vasopressin to the V 2-receptor in the kidney lowers adenylate cyclase activity resulting in a decrease in intracellular adenosine 3', 5'-cyclic monophosphate (cAMP) concentrations. Decreased cAMP concentrations prevent aquaporin 2 containing vesicles from fusing with the plasma membrane, which in turn, causes an increase in urine water excretion, an increase in free water clearance (aquaresis) and a decrease in urine osmolality.

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 Tolvaptan, just click the ADD TO CART button.

HBEL

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