OEL Fastrac Catalog

Choline salicylate is a salicylic acid derivative used in the treatment of pain and fever, and in the management of rheumatic disorders. Choline salicylate is also used as a local analgesic. Solutions containing up to about 20% choline salicylate are used in ear disorders such as the relief of pain in otitis media and externa but are considered to be of doubtful value; they are also used to soften ear wax as an aid to removal. An 8.7% gel is used for lesions of the mouth. Choline salicylate has also been applied topically in a rubefacient preparation for the relief of muscular and rheumatic pain (3). Choline salicylate is also given in the form of choline magnesium trisalicylate.

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 Choline salicylate, just click the ADD TO CART button.

HBEL

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