In addition, APIs must comply with international quality standards, such as those set by the International Conference on Harmonisation (ICH). This helps ensure that APIs produced worldwide are held to the same quality and safety benchmarks.
The synthesis of DMAU involves several straightforward organic chemistry reactions. Starting from uracil, one can introduce methyl groups through alkylation reactions, followed by the introduction of the amino group via nucleophilic substitution. The ability to easily synthesize DMAU allows researchers to produce analogs with varying substituents, thereby facilitating structure-activity relationship studies crucial for drug development.