Review Article
Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing
Table 3
Common ATPs for impurity profile by HPLC method.
| Serial number | Analytical Target Profile (ATP) | CQA with Risk Assessment | Low | Medium | High |
| 1 | Number of analytes (API and impurities) | | | ✓ | 2 | Separation of all analytes | | | ✓ | 3 | Mobile Phase (buffer and organic modifier) | | | ✓ | 4 | Elution method (gradient or isocratic) | | | ✓ | 5 | Sample concentration | | | ✓ | 6 | Sample diluent | | | ✓ | 7 | Sample solution stability | | ✓ | | 8 | Sample preparation process (dilution process and sonication time, etc.) | | ✓ | | 9 | Filter or centrifuge | | ✓ | | 10 | Impurity specification limits | | | ✓ | 11 | Column type (Stationary phase and Dimensions) | | | ✓ | 12 | Detection category (UV/RID/ELSD) | | ✓ | | 13 | RRT, RRF establishment | | ✓ | | 14 | Flow rate | ✓ | | | 15 | Injection volume | ✓ | | | 16 | Column oven temperature | | ✓ | | 17 | Runtime | | ✓ | | 18 | System suitability parameters selection with limits | | ✓ | | 19 | LOD and LOQ concentrations establishment | | | ✓ | 20 | Impurities calculation method establishment | | | ✓ | 21 | Recovery establishment | | | ✓ |
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