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Cleaning Validation for Dexmedetomidine

Posted: Sat Sep 01, 2018 6:13 pm
by tubish81
Hi,


I have developed a method for cleaning validation of dexmedetomidine. Concentration is very low (0.0000001 mg / ml=%100 standard). I hava obtained a peak with HPLC and LC MS MS. However I have not provided linearity in both methods. Area of %120 standard less than % 100 standard. I have tried methods too much. Is the range not appropriate in the methods.

Thank you

Re: Cleaning Validation for Dexmedetomidine

Posted: Sat Sep 01, 2018 7:00 pm
by mattmullaney
Good afternoon,

This may help a bit:

https://www.europeanpharmaceuticalrevie ... n-samples/