Please note, this OEL/ADE monograph also applies to Aspartame hydrochloride (CAS RN 5910- 52-1). Aspartame is a low-calorie, artificial sweetener agent derived from L-aspartic acid and methyl-L phenylalaninate. It is approximately 200 times sweeter than sucrose and has been used as a diet supplement and sugar substitute for many years as, like other sweeteners, it contributes to only a few calories when added to foods. According to the United States Food and Drug Administration (US FDA), high-intense sweeteners such as aspartame are widely used in food and beverages marketed as “sugarfree” or “diet,” including baked goods, soft drinks, powdered drink mixes, candy, puddings, canned food, jams and jellies, dairy products, and many others. Despite being low-calorie, aspartame is classified as a nutritive sweetener by the FDA, as it adds caloric value to the foods that contain it. It has more than 2% of the calories in an equivalent amount of sugar, as opposed to non-nutritive sweeteners that contain less than 2%. In fact, aspartame is the only approved nutritive high-intensity sweetener. Aspartame is also contained in many pharmaceutical products.

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.


CAS Registry Number:
Trade names:
NutraSweet , Sugar Twin , Equal 
$679 USD


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.

How to order

To order an OEL/ADE monograph for Aspartame, 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.
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  • Director of Manufacturing