Analyte Impurities A, B, C and D Solvent E Sample preparation 100 mg of technical product is dissolved in 10 mL of solvent… Instrument HPLC GC Detector MS-MS FID Column Company B tradename, dimensions Mobile phase (for Gradient Isocratic … … LC) or oven temperature (for GC) Quantitation By external standard (lot #, purity) obtained from Commercial Source C OR synthesized/characterized by the applicant see IIA 2.5.2 – Total run time footnotes as applicable Specificity was evaluated by (state method). The remaining validation data are summarized below. … Table 4.2.3-2. Method validation data Component / Method type Linearity (w %) / Retention Accuracy as Precision as LOQ and / Correlation time (min) recovery (%) RSD (%) or LOD (%) coefficient 1 Impurity A / HPLC/MS-MS Impurity B Impurity C Impurity D Solvent E / GC-FID 1 For instrument or method (select appropriate) other footnotes as applicable e.g. details of accuracy or precision determination – Validated analytical methods were provided for determination of the impurities in five batches of the technical product and were assessed to be for this purpose. …
Analyte Impurities A, B, C and D Solvent E Sample preparation 100 mg of technical product is dissolved in 10 mL of solvent… Instrument HPLC GC Detector MS-MS FID Column Company B tradename, dimensions Mobile phase (for LC) or oven temperature (for GC) Gradient … Isocratic … Quantitation By external standard (lot #, purity) obtained from Commercial Source C OR synthesized/characterized by the applicant – see IIA 2.5.2 Total run time footnotes as applicable Specificity was evaluated by … (state method). The remaining validation data are summarized below. Table 4.2.3-2. Method validation data Component / Method type Linearity (w %) / Correlation coefficient Retention time (min) Accuracy as recovery (%) Precision as RSD (%) LOQ and / or LOD (%) 1 Impurity A / HPLC/MS-MS Impurity B Impurity C Impurity D Solvent E / GC-FID 1 For instrument or method (select appropriate) other footnotes as applicable – e.g. details of accuracy or precision determination Validated analytical methods were provided for determination of the impurities in five batches of the technical product and were assessed to be … for this purpose.