N-nitroso-Furosemide

Confirmatory Testing & Analytical Challenges
1

Hi everyone,

The laboratory we commissioned the development of a method for determining N-nitroso-furosemide content in a Drug Product is encountering many difficulties and, even now, after more than a year of work, has not been able to finalize the method. Has anyone found themselves in the same situation, or have you been able to finalize the method for N-nitroso-furosemide determination?

2

Furosemide was kind of a challenge. Some quick tips:

Don’t use water in sample preparation.

Depending on the nitrite content of each product (which varies from batch to batch), we observed quite dramatic in vitro formation.

Using scavengers resulted in decomposition of the nitrosamine.

LC-MS was easy, and the method was robust over a wide range.

What are you struggling with?

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3

Hi,

Attached is the HPLC chromatogram of N-Nitroso Furosemide sodium salt.

Please refer method information above the HPLC peak graph, and see if useful for you.

You can contact me at +91-7567740862/kamal@riverxlab.com for any further information.

Happy to help you :handshake:

FSMD-NO-002-25.pdf (81.0 KB)

4

Hello Matilde, Can you please connect with me on following mail ID? We have qualified method and will be happy to assist you to resolve this issue. Please confirm, are you working on Oral Solution or Parenteral DP. My Mail: PANKAJ.PARTANI@SCIEX.COM

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