analytical target profile (atp) life cycle management analytical procedures analytical control strategy lcms xrd pxrd change management validation method development microwave digestion icpms ms nitrosamine impurity gc amv amt cochran test hplc method developement qtrap ich icpoes gcms gchs lcms method development ion optics method validation method transfer qbd risk management diverter valve interface eic apci analytical method development fitness for use calibration usp 41 balance analytical balance current practice and regulatory requirement homoscedasticity heteroscedasticity linearity data anvisa linearity anvias system suitability rsd assay pka pka determination column column selection fid detector ndma ndba identified risk fact ndsris nitrosamine polymorphism pharmaceutical solid polymorphic forms specifications requirement icp-ms method developmet aas acid digestion acid leaching aqua regia inverse aqua regia icp sample preparation icpms-ms risk assessment root cause analysis prevention and control nitrosamines pharmaceutical products development triplus 500 bragg’s law characterization of crystallin xray x-ray filter type of scan q1 ms q2 ms mrm sim q1 mi q3 mi quadrupole theory ms ms ms ms ms ci ei dp ep cxp ce basic understanding of lcms ion optics path and parameters
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