Module 3 2019

Drug Substance Assay Range

• “The interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the method has a suitable level of precision, accuracy and linearity • Normally derived from linearity study and application of the method • Minimum 80 – 120% of nominal theoretical value • Should cover the range of expected results e.g. for impurities DL to 2 x specification level

The Organisation for Professionals in Regulatory Affairs