Analytical Method Validation


Can I get information about Basics of Analytical Method Validation for Assay & Related Substances for Pharmaceutical products

Dear Radhika,

For Analytical method validation (AMV), ICH (International Conference of Harmonization)guidelines has defined throughly in Q2R1guideline, please go through it after we will discuss it. My email address is

Thanks and best regards,
Shahnawaz sajid
Validation Coordinator


I wish to know how relative response factor for impurities are calculated.

Dear Ramsuthar,
If the impurity standards are available then make linearity solutions of impurity and the prepare also same concentration solution of active analyte. Then draw straight line and find out linear correlation coefficient, slope, Y-intercept and residual sum of square. Then slop of substance divided by the slope of the impurity and multiply these value by impurity %standard , you will be find RRF value. Those impurities in which no authentic reference material is available and for unknown peaks, the RRF is assumed to be 1.00.