Title: Alternative Sweeteners

Neotame 133
products. In all products assessed in the matrix model, the stability of neotame
was demonstrated to be comparable or improved relative to aspartame.
D. Degradation Products
1. Neotame is Not Subject to Diketopiperazine
(DKP) Formation
Degradation studies demonstrate excellent mass balance for neotame. No DKP
is formed from the intramolecular cyclization of the dipeptide moiety of neotame
because of the presence of the N-akyl substitution on the aspartyl amino group.
This results in excellent stability of neotame in baking applications. The possible
formation of Maillard reaction products or in vitro nitrosation of neotame was
also assessed to be negligible. Stability studies have confirmed that products containing
dextrose, maltodextrin, and neotame are stable when stored for extended
periods of time at relevant storage conditions of ambient temperature and humidity.
Neotame is similarly inert to a number of food components such as flavoring
agents and reducing sugars, including fructose.
2. De-esterified Neotame is the Major Degradant
The major route of degradation is the hydrolysis of the methyl ester moiety of
neotame to form de-esterified neotame. De-esterified neotame is the only degradant
formed to any extent and is also the major metabolite of neotame found
in humans and animals. Under relevant conditions of use (pH 3.2 and 20°C),
approximately 89% of neotame remained in mock beverage formulations after 8
weeks of storage. On the basis of product survey data, 90% of diet carbonated
beverages are purchased and consumed within 8 weeks of production.
Carbonated soft drinks represent the largest use category for high-intensity
sweeteners; for example, approximately 80% of all aspartame produced is used
in carbonated soft drinks. The relative pattern for neotame use is not expected
to deviate significantly from that of aspartame. Stability studies done with neotame
in carbonated soft drinks at anticipated use levels did not result in detectable
levels of degradants other than de-esterified neotame.
III. NEOTAME TASTE PROFILE
Neotame has a clean, sweet taste similar to sugar with no significant bitter, metallic,
or other off-tastes. Moreover, this taste profile is maintained over the range
of concentrations required in applications. Taste testing has shown that the sweet-