Rupatadine related Nitrosamine

Limits of Nitrosamines
1

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.

2

Dear Ashish

Desloratadine is a secondary amine, not a tertiary amine. Therefore needs to be considered as a nitrosamine precursor in the drug product, specially since 0.5% is potentially a large amount of secondary amine

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