OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to netarsudil mesylate (CAS RN 1422144-42-0) and netarsudil hydrochloride (CAS RN 1253952-02-1). Netarsudil is a Rho kinase inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Netarsudil is a rho kinase inhibitor with norepinephrine transport inhibitory activity that reduces production of aqueous humor. The exact mechanism of netarsudil is unknown. It is suggested that netarsudil possess inhibitory action against the norepinephrine transporter, preventing reuptake of norepinephrine at noradrenergic synapses and increasing the strength and duration of norepinephrine signaling. Norepinephrine-induced vasoconstriction reducing blood flow to the ciliary body may subsequently be responsible for the reduction of aqueous humor.

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 Netarsudil, just click the ADD TO CART button.

HBEL

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