OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Pridinol mesilate/ methanesulfonate (CAS RN 6856-31-1) amd Pridinol hydrochloride (CAS RN 968-58-1). Pridinol is an atropine-like muscle relaxant indicated in the symptomatic treatment of muscle spasm and muscle pain associated with muscle tightness. Pridinol is used as an adjunct in all forms of parkinsonism and is also used in the treatment of diseases that are associated with increased muscle tension of the locomotor system, both of central origin (as in the case of cerebral vascular diseases, tremors due to Parkinson's disease, spinal cord diseases or injuries, etc.) and of peripheral origin (as in the case of osteoarthritis, for example lumbosacral, herniated intervertebral disc, low back pain due to exertion, flat feet, sciatica, torticollis, general muscle pain, nocturnal cramps, etc.). Pridinol is also used in premedication before or during rehabilitation procedures.

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 Pridinol, just click the ADD TO CART button.

HBEL

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