What will do One pair showing below 10% and second pair out of limit.
That´s difficult to answer given the amount of information. The best way would be to use an risk based approach and continue with the out of limit one, but if they don´t match then it is an indication that your method is not performing optimally, for example coelution.
But have booth transitions been validated ? Is the ratio Qaul/Qaunt the same for your reference and your test solution or are there any deviations ?
Have you already performed accuracy ?
With that less information it is difficult to help.
It is difficult to interpret based on only this information.
Please provide more information
Dear @chetansikchi thank you for sparking this conversation! To help the community dive deeper and offer more targeted insights, could you add a few extra details about the challenge you’re seeing? For example:
- Product or process context – is this related to an API, finished dosage form, excipient, or something else?
- Analytical approach – what have you used so far, and what results have you observed?
- Regulatory or risk-assessment angle – are you working toward a specific guideline or facing a particular compliance hurdle?
- Sticking points – what part of the investigation is proving most difficult?
The more detail you can share, the easier it will be for fellow members—many of whom have tackled similar issues—to jump in with practical suggestions, references, or even illustrative case studies. I’m looking forward to the follow-up and a rich discussion!
This is regarding finished product of Nizatidine capsule for NDMA content.
While method development taken two MRM pair as 75.10_43.10 (Qualifier)& 75.10-58.10 (Quantifier)
In Qualifier pair showing sample pattern initial to NDMA RT and on RT of NDMA showing peak in sample solution. But in Quantifier pair not any sample pattern. For Qualifier having low area response compare to Quantifier.
My question is which pair to be selected for reporting.
While method development used low sample conc. and high length of column. Chromatography also changed but scenario same as mentioned above
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For NDMA, DMF could be a possible Interference. It influences the 75.1 → 58.1 Transistion. So if this is higher, i think rejection would be plausible.
A new approach for the analysis of n-nitrosodimethylamine (NDMA) in pharmaceutical products
This was my thought as well - if it is only showing elevated levels in the quantifier at 58.1 then this could well be the problem.
Worth checking for any potential sources of DMF and investigating the methods that are capable of separating the NDMA from DMF.
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