How many injections are needed when carrying out specificity and precision with HPLC?
For specificity and precision tests, it is recommended to carry out a similar number of injections that cover the number of samples that will be analysed by HPLC in a typical biorelevant dissolution run. For biorelevant testing of a single drug product in one medium (n = 6 vessels) this usually equates to around 50 to 60 injections.