The trade name terminology, nylon, has been firmly established as applying only to polyamides polymerized from unsubstituted, nonbranched aliphatic monomers. Unfortunately, variations of these names are dispersed throughout the literature, such as nylon 6/6, 66-nylon, 6,6-nylon, and 6-6-nylon, all indicating nylon-66. The numbers added to the word “nylon” are indicative of the number of methylene groups (wherein the acid carbonyl can be counted as a theoretical methylene) in a monomer. Nylon analogues with two numbers added to the name represent polyamides synthesized from two distinct monomer units. Nylon-66, for example, is the polyamide synthesized from hexylenediamine and adipic acid (wherein each monomer has six methylene groups). Nylon-66 is also known as polyamide-66 (PA 6,6). Nylon-66, nylon-11, nylon-12, nylon 6/12, and nylon-6 have been approved by the Food and Drug Administration (FDA) as indirect food additives used for food contact surfaces. Nylon- 66 and nylon-6 are used in nonabsorbable surgical sutures, which are FDA-approved medical devices. Nylon ingredients, such as nylon-6, are used as bulking and opacifying agents in cosmetic formulations.
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.
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 Nylon-66, 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.