Unknown Impurity of Sertraline - Formamide?

Hi.

This is a common problem and we have discussed it in this thread.

N-formyl is a common impurity in many drug products where the secondary amine reacts with formaldehyde or formic acid present in trace levels in excipients. This will increase on stability. (For eg N-formyl varenicline)
These impurities are monitored in percentage levels in the RS method. Since the magnitude is 100-1000 times higher than the nitrosamine, you have to chromatographically separate it. Also note that the levels of N-formyl impurity at the end of shelf life will be higher so account for that in your separation process.

This impurity can be synthesized or procured. I suggest to get the standard of this impurity and use it in your method development along with the nitrosamine.

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