Module 3 Presentations
07/05/2024
• 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 • For LOD – follow method 2 above but with 3:1 being a suitable S/N ratio
Question: Is LOD relevant if routinely measuring LOQ?
The Organisation for Professionals in Regulatory Affairs
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LOD / LOQ for Impurities
The Organisation for Professionals in Regulatory Affairs
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