Olopatadine

Please note, this OEL/ADE monograph also applies to Olopatadine HCl (CAS RN 140462-76-6). Olopatadine is a histamine antagonist indicated for the treatment of ocular itching associated with allergic conjunctivitis as an ophthalmic solution and for the relief of seasonal allergies rhinitis as a nasal spray. Olopatadine is a selective histamine H1 antagonist and mast cell stabilizer that exerts its effect by inhibiting the release of histamine from mast cells. Olopatadine binds and blocks the H1 receptor signaling pathway, inhibiting the release of inflammatory mediators, including tryptase, prostaglandin D2, TNF-α, and pro-inflammatory cytokines. Olopatadine also decreases chemotaxis and inhibits eosinophil activation. In vitro, olopatadine was shown to inhibit epithelial cell intercellular adhesion molecule-1 (ICAM-1), which promotes the recruitment of migrating pro-inflammatory mediators.

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.

Olopatadine

CAS Registry Number:
113806-05-6
Brand names:
Patanol®, Pataday®, Patanase®, Pazeo®
Cost:
$639 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), 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. 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.

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To order an OEL/ADE monograph for Olopatadine, just click the ADD TO CART button.

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Affygility Solutions’ 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