Tag: Analytical method validation protocol

SOP for Analytical Method Development Elemental Impurity Testing Elemental Impurity Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting elemental impurity testing during the analytical method development process, ensuring the identification and quantification of elemental impurities in pharmaceutical products. 2) Scope This SOP applies to…

Read More “SOP for Analytical Method Development Elemental Impurity Testing” »

SOP for Analytical Method Development Analytical Instrument Qualification (AIQ) Analytical Instrument Qualification (AIQ) in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting analytical instrument qualification (AIQ) during the analytical method development process, ensuring that analytical instruments meet predefined acceptance criteria. 2) Scope This SOP applies to…

Read More “SOP for Analytical Method Development Analytical Instrument Qualification (AIQ)” »

SOP for Analytical Method Development Stability Testing of Analytical Solutions Stability Testing of Analytical Solutions in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting stability testing of analytical solutions during the analytical method development process, ensuring the stability of solutions over time. 2) Scope This SOP…

Read More “SOP for Analytical Method Development Stability Testing of Analytical Solutions” »

SOP for Analytical Method Development Limit of Quantification (LOQ) Testing Limit of Quantification (LOQ) Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting limit of quantification (LOQ) testing during the analytical method development process, determining the lowest concentration of an analyte that can be reliably…

Read More “SOP for Analytical Method Development Limit of Quantification (LOQ) Testing” »

SOP for Analytical Method Development Limit of Detection (LOD) Testing Limit of Detection (LOD) Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting limit of detection (LOD) testing during the analytical method development process, determining the lowest concentration of an analyte that can be reliably…

Read More “SOP for Analytical Method Development Limit of Detection (LOD) Testing” »

SOP for Analytical Method Development Precision Testing Precision Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting precision testing during the analytical method development process, ensuring the repeatability and reproducibility of the method. 2) Scope This SOP applies to all personnel involved in precision testing…

Read More “SOP for Analytical Method Development Precision Testing” »

SOP for Analytical Method Development Accuracy Testing Accuracy Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting accuracy testing during the analytical method development process, ensuring the closeness of test results to the true value of the analyte. 2) Scope This SOP applies to all…

Read More “SOP for Analytical Method Development Accuracy Testing” »

SOP for Analytical Method Development Linearity Testing Linearity Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting linearity testing during the analytical method development process, ensuring the ability of the method to produce results that are directly proportional to the concentration of the analyte. 2)…

Read More “SOP for Analytical Method Development Linearity Testing” »

SOP for Analytical Method Development Specificity Testing Specificity Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting specificity testing during the analytical method development process, ensuring the ability of the method to distinguish the analyte from potential matrix components or impurities. 2) Scope This SOP…

Read More “SOP for Analytical Method Development Specificity Testing” »

SOP for Analytical Method Development Selectivity Testing Selectivity Testing in Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting selectivity testing during the analytical method development process, ensuring the ability of the method to differentiate the analyte from potential interferences. 2) Scope This SOP applies to all…

Read More “SOP for Analytical Method Development Selectivity Testing” »