The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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.
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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.
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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.
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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 quantified with acceptable precision and accuracy.
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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 detected.
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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.
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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.
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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.
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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.
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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.
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