OEL Fastrac Catalog

Carbazochrome sodium sulfate is indicated for use as a hemostatic agent and has been used in the treatment of hemorrhoids. It has also been used for frostbite due to decreased peripheral vascular resistance and many other indications requiring a hemostatic effect. The mechanism of action of carbazochrome sodium sulfate is unknown, but it may modulate fibrinolysis through alteration of endothelial cell function. It is an antihemorrhagic, or hemostatic agent, that is thought to cease blood flow by causing the aggregation and adhesion of platelets in the blood to form a platelet plug, ceasing blood flow from an open wound. Carbazochrome sodium sulfate has a capillary stabilizing action on endothelial barrier dysfunction that may be induced by a variety of vasoactive substances or agents that increase the vascular permeability. It also reduces the vascular hyperpermeability induced by a variety of vasoactive agents through inhibition of agonist-induced phosphoinositide hydrolysis.

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 Carbazochrome Sodium Sulfonate, just click the ADD TO CART button.

HBEL

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