4-Aminosalicylic acid

Please note, this OEL/ADE monograph also applies to 4-aminosalicylic acid sodium dihydrate (CAS RN 6018-19-5). 4-Aminosalicylic acid, also known as para-aminosalicylic acid (PAS), is an anti-mycobacterial second line medication indicated for the treatment of active tuberculosis. It is also indicated as part of an appropriate combination regimen with other anti-tuberculosis drugs (most often isoniazid or streptomycin) for multi-drug resistant tuberculosis (MDR-TB) in adults and pediatrics patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The sodium salt of aminosalicylic acid is better tolerated than the free acid.

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.

4-Aminosalicylic acid

CAS Registry Number:
65-49-6
Trade names:
Paser®, Granupas®
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.

How to order

To order an OEL/ADE monograph for 4-Aminosalicylic acid, just click the ADD TO CART button.

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  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories