Protocol

Determination of Total Organic Carbon Protocol | IVT

This report describes the results and provides conclusions on the validation of SWI J00XXXX, “The Determination of Total Organic Carbon Using the XXXXX TOC Analyzer” of Soybean Casein Media. SWI J00XXXX revision 2.0 is a validated method (See Report C0XXXX and C0XXXX) and this was an extension of the existing validations used for impurity analysis. The quantitative method for impurity analysis was validated for accuracy, precision, specificity, linearity, range and limit of quantitation in accordance with SOP A000XXX revision 3.0, Optimization and Validation of Analytical Procedure and Verification of Compendia Methods.

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