Module 3 2019

Drug Substance Assay Specificity

• “Ability to assess unequivocally the analyte in the presence of components which may be expected to be present”

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Dependant on method application

• May require a combination of two or more methods

• Retention time recording of structurally related impurities, degradation products etc recorded during method development • Peak homogeneity can be carried out during stress testing studies using either (simply) LC- DAD and/or LC-MS or multiple methods

The Organisation for Professionals in Regulatory Affairs