Sir,
i want to know which parameters needed to validate the product by potentometer
vasu
For “Assay validation by potentiometry” degradation studies are necessary or not? Please conform
Dear Freind
First u decide wether u r talking abt product or Analytical method? as u said “i want to know which parameters needed to validate the product by potentometer”
anyways!! there are the same parameters for Potentiometric Assay method validation as it is recomended for HPLC method Validation. yes system suitability u dont need to do as it is required for HPLC but infact that system suitability is done before starting even a routine analysis. some parameters can be changed accordingly, like in robustness of HPLC method u change wave length, flow rate, Oven temperature etc etc. here for this potentiometric analysis for example u can slightly change the concentration of 0.1 N perchloric acid, u can change the amount of indicator…
Yes solution stability of sample is necessary its a part of validation.
Regards,
Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia
thank you sir;)