Montelukast sodium

Montelukast sodium is used for long-term prevention of asthma. It reduces the swelling and inflammation that tend to close up the airways and relaxes the walls of the bronchial tubes, expanding the airways and permitting more air to pass through. Montelukast is also used to relieve the stuffy, runny nose and sneezing caused by seasonal allergies. Montelukast sodium is an anti-inflammatory agent that binds to cysteinyl leukotriene type 1 receptors found in smooth muscle cells and macrophages of the upper and lower airways to prevent leukotriene-mediated effects associated with asthma and allergic rhinitis. To obtain a detailed potent compound classification and occupational exposure limit report for montelukast sodium, please click on the order now button to the right. This report is of high value and comparible reports cost five to ten times as much as this report being offered online.

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.

Montelukast sodium

CAS Registry Number:
158966-92-8
Brand name:
Singulair
Cost:
$597 USD

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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), 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. 10-12 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 this compound, just click the ADD TO CART button.

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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories