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.