OEL Fastrac Catalog

Isosorbide dinitrate is the dinitrate salt form of isosorbide, an organic nitrate with vasodilator activity. It is indicated for the prevention of angina pectoris due to coronary disease. Isosorbide dinitrate has also been investigated in myocardial infarction. Isosorbide dinitrate is also indicated intravenously (IV) for the treatment of unresponsive left ventricular failure, secondary to acute myocardial infarction, unresponsive left ventricular failure of various etiologies and severe or unstable angina pectoris. It is also used to facilitate or prolong balloon inflation and to prevent or relieve coronary spasm during percutaneous transluminal coronary angioplasty.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).

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 monograph for Isosorbide dinitrate, just click the ADD TO CART button.

HBEL

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