Research Article
Development and Validation of LC-MS/MS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials
Table 4
Amount of impurities C–H in starting material DMBZ.
| PGIs (ng/mL) | Batch no | 20130323 | 20130519 | 20141001 | 20180903 | 20181001 | 20181003 |
| Impurity C | 1.54 | 0.50 | 0.50 | 0.02 | 0.04 | 0.05 | Impurity D | 0.49 | 0.19 | 0.19 | 0.02 | 0.07 | 0.05 | Impurity E | 0.04 | 0.03 | 0.27 | 0.67 | 0.36 | 0.61 | Impurity F | 0.17 | 0.24 | 0.02 | 0.01 | 0.01 | 0.01 | Impurity G | 0.60 | 0.09 | 0.09 | 0.02 | 0.04 | 0.01 | Impurity H | 0.12 | 0.07 | 0.07 | 0.01 | 0.01 | 0.01 |
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The calculated value is lower than the LOQ, for reference only. |