Module 3 2019

• Various experimental methods • Two common methods 1. Drug Substance Impurities Organic Impurities by HPLC

LOQ is level where replicate injections of analyte have an RSD of less than 10%. 2. LOQ level where S/N ratio = 10:1 But need to consider regional requirements / interpretation • The LOQ needs to be below the reporting threshold for the impurity as given by ICH Q3A(R2) (0.05% for  2g/day drug) • For LOD – follow method 2 above but with 3:1 being a suitable S/N ratio

Question: Is LOD relevant if routinely measuring LOQ?

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