Aspartame

Aspartame Impurities

Aspartame impurities include synthetic intermediates, process-related compounds, degradation products, and residual solvents that may arise during synthesis, formulation, or storage. As a low-calorie artificial sweetener composed of the methyl ester of the dipeptide of aspartic acid and phenylalanine, impurity profiling is essential to ensure product safety, sensory quality, and regulatory compliance. Known degradation pathways include hydrolysis, diketopiperazine formation, and methanol release under elevated temperature and pH conditions. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Aspartame EP Impurities

Pharmacopeial and non-pharmacopeial Aspartame impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and stability testing. EP traceable materials are supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Aspartame Related Compounds

Structurally related compounds and synthetic analogs associated with Aspartame are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Aspartame Impurity Reference Standards

Aspartame impurity reference standards are provided with validated analytical data including purity, NMR, MS, and full Certificates of Analysis. These standards are used in food additive research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.