Ambroxol → (1,3-Dimethyl-2,6-dioxo-1,2,3,6-tetrahydro-7H-purin-7-yl)acetic acid--4-(((2-amino-3,5-dibromophenyl)methyl)amino)cyclohexan-1-ol (1/1)

Participants

Reaction Conditions

Reaction Steps

The solution of ambroxol base in non-polar solvent is added to the flask containing theophylline-7-acetic acid and non-polar solvent under stirring while maintaining the temperature between 60-85° C. The addition time is 2-3 minutes. The reaction mixture is heated at the temperature between 60-105° C. with continuous stirring for 25-35 minutes. The reaction mixture is allowed to cool to the room temperature. A solid product is formed. This solid product is separated by filtration. The product is washed with the small amount of non-polar solvent and dried. The yield of Acebrophylline obtained is 95-98% of the theoretical yield. The yield of Acebrophylline is 154-159% of the weight of ambroxol base. The purity of Acebrophylline thus obtained as measured by HPLC is more than 99%.

Provenance & Evidence