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How to fix the sample concentration in related substances development.

Answer Posted / dr.v.gangadhar 07702224651

find out the concentration based on signal to noise ratio of the impurity which is eluted with low responce. S/N should be greater than 30 for Specification level. (0.15% or 0.10%)(Minimum three times higher than the LOQ value and 10 times higher than LOD.

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