FPA data on alitame are provided in Table 1. As can be seen by inspection of these data, alitame exhibits a clean, sweet taste comparable to sucrose taste. No off-tastes are observed. Unfortunately, temporal profile data on alitame are not available, and so it is not possible to quantitatively compare it to sucrose in this dimension. In general, however, alitame's sweetness appears to linger somewhat, much as is the case for aspartame.
C/R function data on alitame are provided in Table 1. Its sweetness potency drops off with increasing sucrose reference concentration just as is the case for saccharin, cy-clamate, aspartame, acesulfame-K, and sucralose. Thus, from the C/R function given in Table 1, Pw(2) = 4440, Pw(8) = 2350, and Pw(10) = 1640 are calculated for alitame.
In 1986, Pfizer submitted an FAP to the U.S. FDA requesting broad approval for use in foods and beverages. At about the same time, approval was also requested in many other countries. At this point, approval for use in the United States has not yet been granted. However, broad clearance for use has been obtained in several countries, including Australia, Chili, China, Columbia, Indonesia, Mexico, and New Zealand. An ADI for alitame of 1 mg/kg was recommended by JECFA after review of all the safety assessment studies conducted. Alitame slowly breaks down in acidic food and beverage products to l-yS-aspartyl-N-(2,2,4,4-tetramethyl-3-thietanyl)-d-alanine amide and N-(2,2,4,4-tetramethyl-3-thietanyl-d-alanine amide, and for this reason, it was required that safety studies be carried out on alitame and these two degradation products.
Alitame's solubility in water is high (131g/L w/v) and is only slightly sensitive to pH. If, for illustration, the Pw(8) = 2350 value of alitame is employed, it can be calculated that alitame is >3800 times as soluble as necessary to match the sweetness intensity of 8% sucrose.
The stability of alitame is substantially better than that of aspartame, though not as high as that of saccharin. Its hydrolytic stability is very sensitive to pH. In the pH range of 2 to 4, alitame is 2 to 3 times more stable than aspartame, while in the pH range of 5 to 8, it is >1000 times more stable. As already mentioned, it does slowly break down to L-/?-aspartyl-N-(2,2,4,4-tetramethyl-3-thietanyl)-d-alanine amide and N-(2,2,4,4-tetramethyl-3-thietanyl)-d-alanine amide in acidic food systems. However, the loss of alitame is insufficient to significantly affect the shelf life of most products. Alitame is limited, however, in that it does break down in acidic systems, by an unknown pathway, to produce trace levels of a sulfurous breakdown product or products. This limitation is particularly evident in cola beverages. In summary, it can be said that alitame is sufficiently stable for most food applications but is not an alternative for acidic products that require a long shelf life.
At the present time, there are four high-potency nonnutri-tive sweeteners that have achieved widespread use in the food industry, and there are two newcomers that are expected to see significant use in the future. Comparative data on these sweeteners are given in Table 2.
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