Dear Expert.
Need expert opinion for the mentioned topic
Desloratadine (Impurity-B) is specified in the API specification with a limit of NMT 0.5%.
Desloratadine contains a tertiary amine functionality and is considered a structurally related impurity.
Based on the above information, we would like to seek your opinion on the following:
Additionally, does the presence of Desloratadine (Impurity-B) warrant any specific concern or further evaluation from a nitrosamine risk perspective for N nitro Desloratadine?
Need expert advice or suggestions.
Thanks in advance.