OEL Fastrac Catalog

Note, this monograph also applies to tizanidine HCl (CAS RN 64461-82-1).Tizanidine is and antispasmodic agent and skeletal muscle relaxant indicated for the management of muscle spasticity associated with multiple sclerosis or with spinal cord injury or disease. Tizanidine reduces spasticity by causing presynaptic inhibition of motor neurons by acting as an agonist at α2-adrenergic receptor sites. The action of tizanidine leads to a reduction in the release of excitatory amino acids like glutamate and aspartate, which cause neuronal firing leading to muscle spasm. The strongest effect of tizanidine has been shown to occur on spinal polysynaptic pathways.

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 Tizanidine, just click the ADD TO CART button.

HBEL

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