Lysine Clonixinate

Please note, this OEL/ADE monograph also applies to lyssine clonixin (CAS RN 17737-65-4). Lysine clonixinate is a non-steroidal anti-inflammatory drug (NSAID) indicated for use in the relief of pain, the management of chronic arthritic conditions, and certain soft tissue disorders associated with pain and inflammation. Lysine clonixinate is a non-narcotic analgesic, derived from anthranilic acid, that is presumed to function similarly to other NSAIDs by inhibiting cyclooxygenase enzymes 1 and 2 responsible for prostaglandin production, resulting in vasodilation and analgesia (2, 4). Prostaglandins PGE and PGF 2 are directly responsible for the stimulation of pain neuroreceptors, and when lysine clonixinate blocking its production, the uptake of painful sensitivity is prevented, regardless of the cause. It has also been shown that lysine clonixinate inhibits the bradykinin and PGF 2 already produced, so it is considered as a direct antagonist of pain 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.

Lysine Clonixinate

CAS Registry Number:
Trade names:
Dolex®, Dolamin®, Colmax®, Prestodol®
$679 USD


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.
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  • Save money. Similar documents cost 5-12 times as much.
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