Table 1.
Control-noise-experimentation (CNX) approach.
| Critical method parameter | Critical method attributes | Initial risk assessment scores | C,N,X | Experimental strategy | ||
|---|---|---|---|---|---|---|
| Retention time | Asymmetric factor | Resolution | ||||
| Isocratic Binary Parameter | 2 | 2 | 2 | 40 | C | Calibrated |
| Flow Rate | 10 | 10 | 10 | 300 | X | DOE |
| Stationary Phase | 5 | 5 | 5 | 100 | C | New Column |
| Particle size | 2 | 2 | 2 | 40 | C | Optimum |
| Dimension | 2 | 2 | 2 | 40 | C | Standard |
| Column Temp | 5 | 5 | 5 | 100 | N | Ambient |
| Buffer pH | 10 | 10 | 10 | 300 | X | DOE |
| % organic Modifier | 10 | 10 | 10 | 300 | X | DOE |
| Solvent Grade | 5 | 5 | 5 | 100 | N | UFLC grade |
| Injection Vol | 2 | 2 | 2 | 40 | C | 20µL |
| Flow Cell temp | 5 | 5 | 5 | 100 | C | 400 C |
| PDA | 5 | 5 | 5 | 100 | N | Standard |
C-Control, N-Noise & X-Experiment Score Low Risk-2, Medium Risk-5 & High Risk- 10. Total Score = (Risk level of First CMA × 10) + (Risk level of Second CMA × 10).