According to the Federal Register notice dated September 21st, 2008, Papain is not FDA approved in the United States. Papain is a naturally occurring protein derived from papaya. It is, or has been used, for the treatment of pain and swelling, as a digestive enzyme, treatment of various parasites, and to treat wounds, sores and ulcers. It is also used in manufacturing, in cosmetics, toothpaste, contact lens cleaners, meat tenderizer and meat products, and in the textile industry.
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.
Please note, due to the complexity and amount of studies regarding this compound, an increased cost is charged.
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:
To order an OEL/ADE monograph for Papain, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.