analytical target profile (atp) life cycle management analytical procedures lcms analytical control strategy change management validation ms amt amv nitrosamine impurity qtrap pxrd xrd method development gc hplc method developement ich cochran test ndsris identified risk fact ndba ndma ion optics path and parameters basic understanding of lcms ce cxp ep dp ei ci ms ms ms ms ms quadrupole theory q3 mi q1 mi sim mrm q2 ms q1 ms type of scan x-ray filter xray characterization of crystallin bragg’s law triplus 500 gcms gchs lcms method development ion optics diverter valve apci eic interface fitness for use analytical method development risk management qbd method transfer method validation development detector fid column selection column pka determination pka assay rsd system suitability anvias linearity anvisa linearity data heteroscedasticity homoscedasticity current practice and regulatory requirement analytical balance balance usp 41 calibration
Mehr anzeigen