law://eu/reg/2012/231/anx_1__grp_364@2026-11-12| Synonyms | |
| Definition | Advantame (ANS9801) is produced by chemical synthesis in a three-step process; production of the principal manufacturing intermediate, 3-hydroxy-4-methoxycinnamaldehyde (HMCA), followed by hydrogenation to form 3-(3-hydroxy-4-methoxyphenyl) propionaldehyde (HMPA). In the final step, the HMPA methanol solution (filtrate) is combined with aspartame to give the imine that under selective hydrogenation forms advantame. The solution is allowed to crystallise and crude crystals are washed. The product is re-crystallised and crystals are separated, washed and dried. |
| CAS No. | 714229-20-6 |
| Chemical name | N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (IUPAC);L-phenylalanine, N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-L-alpha-aspartyl-, 2-methyl ester, monohydrate (CA) |
| Molecular formula | C24H30N2O7·H2O |
| Molecular weight | 476,52 g/mol (monohydrate) |
| Assay | Not less than 97,0 % and not more than 102,0 % on an anhydrous basis |
| Description | White to yellow powder |
| Identification | |
| Melting Point | 101,5 °C |
| Purity | |
| N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl-α-aspartyl]-L-phenylalanine (ANS9801-acid) | Not more than 1,0 % |
| Total other related substances | Not more than 1,5 % |
| Residual Solvents | Isopropyl acetate: Not more than 2000 mg/kgMethyl acetate: Not more than 500 mg/kgMethanol: Not more than 500 mg/kg2-Propanol: Not more than 500 mg/kg |
| Water content | Not more than 5,0 % (Karl Fischer method) |
| Residue on ignition | Not more than 0,2 % |
| Arsenic | Not more than 2 mg/kg |
| Lead | Not more than 1 mg/kg |
| Palladium | Not more than 5,3 mg/kg |
| Platinum | Not more than 1,7 mg/kg |
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