OEL Fastrac Catalog

Manidipine hydrochloride is indicated for use in the treatment of hypertension. Manidipine is a calcium channel antagonist (dihydropyridine type) with a high degree of selectivity for vasculature. Because of this selectivity, manidipine induces peripheral vasodilation without producing significant effects on the heart or central nervous system at clinically relevant doses. It binds to and dissociates slowly from L- and T-type voltage dependent calcium channels on smooth muscle cells, blocking the entrance of extracellular calcium into the cell and preventing contraction of vascular smooth muscle. This produces vasodilation, which decreases blood pressure. Manidipine produces renal vasodilation and an increase in natriuresis (sodium excretion in the urine), which likely contributes to the antihypertensive effect by reducing blood volume.

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 Manidipine Hydrochloride, just click the ADD TO CART button.

HBEL

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