Oxycodone

Please note, this OEL/ADE monograph also applies to oxycodone hydrochloride (CAS RN 124-90-3). Oxycodone is an opioid analgesic used to treat diarrhea and pulmonary edema, and for the relief of moderate to severe pain. The precise mechanism of the analgesic action is unknown. However, specific central nervous system opioid receptors for endogenous compounds with opioid like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of oxycodone. Oxycodone-induced analgesia occurs without loss of consciousness and other sensory modalities like touch, vibrations, vision and hearing are not affected. Oxycodone acts a weak agonist at mu, kappa, and delta opioid receptors within the CNS, primarily affecting mu-type opioid receptors. These are coupled with G-protein receptors and function as modulation of synaptic transmission. Binding of opiates such as oxycodone inhibit the release of nociceptive neurotransmitters including substance P, GABA, dopamine, acetylcholine, and noradrenaline.

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.

Oxycodone

CAS Registry Number:
76-42-6
Brand names:
Oxecta®, Oxaydo®, Oxycontin®, Oxyneo®, Roxicodone®, Roxybond®, and Xtampza®
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), 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 Oxycodone, just click the ADD TO CART button.

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Affygility Solutions’s 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
  • Pharmatek Laboratories