Validation of titration methods and qualification of a titrator using the content determination of ephedrine hydrochloride as an example
In contrast, to HPLC, titration is an absolute method and therefore requires no reference method.
The reaction processes are known; the titration takes place strictly stoichiometrically and normally very rapidly.
If a titrant with a known titer is used then the content of the sample can be determined directly. However, this applies only to raw materials and not to formulations that contain other components that could react with the titrant in a similar or identical manner.
It does not make sense to qualify the individual components of an analytical instrument or analysis system separately.
On the contrary, the complete titration system (titrator, buret, electrode, titration evaluation, sample changer if present) is subjected to a performance check.
The qualification of the titrator and the validation of the titration method are carried out at the same time.
