Analysis methods used to determine purity, described in the protocol(s) shall be based on the validated dose analysis method for the chemical, test article or sample and shall include an internal standard. The protocol purity method shall employ calculation of a relative response factor (RRF) for replicate analyses of the chemical or test article and a frozen reference sample of the same lot. A mean and 95% confidence interval (CI) shall be calculated for the frozen reference sample RRF. The RRF for the chemical or test article is compared to the RRF for the frozen reference. When the RRF for the chemical or test article, lies outside the 95% CI of the frozen reference standard, the testing lab shall be instructed to contact the study director. The Contractor shall perform the method as described by the draft Characterization Protocol using an aliquot of the bulk chemical, test article, or sample. Additional Requirements The Contractor shall report the work done in this Functional Activity following the reporting requirements given in Section 4. Reporting Requirements.
Analysis methods used to determine purity, described in the protocol(s) shall be based on the validated dose analysis method for the chemical, test article or sample and shall include an internal standard. The protocol purity method shall employ calculation of a relative response factor (RRF) for replicate analyses of the chemical or test article and a frozen reference sample of the same lot. A mean and 95% confidence interval (CI) shall be calculated for the frozen reference sample RRF. The RRF for the chemical or test article is compared to the RRF for the frozen reference. When the RRF for the chemical or test article, lies outside the 95% CI of the frozen reference standard, the testing lab shall be instructed to contact the study director. The Contractor shall perform the method as described by the draft Characterization Protocol using an aliquot of the bulk chemical, test article, or sample. Additional Requirements The Contractor shall report the work done in this Functional Activity following the reporting requirements given in Section 4. Reporting Requirements.