Problem: Writing an Analytical Method Verification SOP Assignment: Use USP 29 assay method for Cupric Sulfate and using course materials and online sources generate an SOP (Standard Operating Procedure) for the verification of the USP method (assay) that characterizes the suitability of analytical characteristics (performance of the test method).
An SOP that explains how to conduct analytical method verification for an assay USP method 29.
Assignment Details:
Use the SOP template provided
Find USP 29 (used in your QC labs- Experiment #4) for Cupric Sulfate- Assay
Provide a copy USP 29
SOP should include:
Principles of the Method and Verification Approach
Important characteristics and how the test method will be used (what it will test)
Protocol and Report
Testing requirements for applicable validation characteristics (Specificity, Accuracy, Precision, Linearity, Range, Detection Limit, Quantitation Limit, Robustness, Ruggedness)
Acceptance Criteria
Raw Data
Equipment and Materials
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