Please note, this OEL/ADE monograph also applies to Penicillamine hydrochloride (CAS RN 2219-30-9) and Penicillamine disulfide (CAS RN 312-10-7; 20902-45-8; 21174-80-1). Penicillamine is indicated for the treatment of cysteine stone formation in the urinary system, rheumatoid arthritis and Wilson’s disease (copper accumulation in vital organs). Chelating agent for penicillamine chelates mercury, lead, copper, iron, and probably other heavy metals to form stable, soluble complexes that are readily excreted in the urine. The mechanism of action of penicillamine in rheumatoid arthritis is not known, but may involve improvement of lymphocyte function. It markedly reduces IgM rheumatoid factor and immune complexes in serum and synovial fluid, but does not significantly lower absolute concentrations of serum immunoglobulins. In vitro, penicillamine depresses T-cell but not Bcell activity. However, the relationship of these effects to the activity of penicillamine in rheumatoid arthritis is not known. For cysteine stone formation, penicillamine combines chemically with cysteine (cysteine–cysteine disulfide) to form penicillamine–cysteine disulfide, which is more soluble than cysteine and is readily excreted. As a result, urinary cysteine concentrations are lowered and the formation of cysteine stones is prevented. With prolonged treatment, existing cysteine stones may be gradually dissolved.

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.


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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), 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.

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To order an OEL/ADE monograph for Penicillamine, just click the ADD TO CART button.


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Affygility Solutions’ 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