if your impurity coeluting with each other in that situation how require to set specification? is it acceptable?
what is mean by extactable and leachable study?
how to calculate elemental impurities?
how you fix the limits of impurities?
what is mean by nitrosamine impurities?
if instrument calibration fails then what require to do?
why require the ph, buffer during hplc mobile phase?
is it nessesary to do solution stability for 7 days?
which are the diffrent batches in the pharmaceuticals?
why xterra column require to use at higher ph?
in which situation require to take incident in validation?
what are the guidelines for analytical method validations?
how require to fix the linearity and accuracy cincentration range?
how many types of balance calibration test?
What if impurity area in control sample coming more as compared to LOQ level of impurity ?