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- Posts: 13
- Joined: Thu Sep 20, 2018 10:43 am
I have a deficiency letter from one authority that wants us ''Signal to noise ratio has been compliant (> 10) for both impurity A and impurity D at a concentration of 0.0003 mg/ml each. The corresponding LODs and LOQs for impurity A and impurity D should be indicated in terms of relative concentration in the finished product.''
Our results is below. We didn't perform LOD parameter in the validation because it is not necessary according to ICH.
Signal-to-Noise (S / N)
Compound Concentration (mg / mL) Acceptance Criteria Average Result
Impurity A 0.0003 not less than 10 19
Impurity D 0.0003 not less than 10 19
What is means ''relative concentration''?
Thank you