QC Laboratory • HPLC Bay 02 • Instrument HPLC-07
System Suitability Dashboard
Critical-pair resolution1.62
Tailing factor1.28
Theoretical plates6,870
Area %RSD (6 std inj.)0.18%
Training method IMP-HPLC-042 Rev 7 defines these scenario-specific criteria: Resolution ≥ 2.00; Tailing ≤ 2.00; Plates ≥ 3,000; Standard area %RSD ≤ 2.00%. These are not universal HPLC limits.
Current gate
FAILED — critical-pair resolution does not meet the approved method criterion. Sample injections have not started.
Chromatogram Viewer
Critical pairImpurity D / API
Calculated resolution1.62
Sequence Table
| # | Injection | Type | Status | Key note |
|---|---|---|---|---|
| 1–6 | SST_STD_01–06 | Qualified SST standard | Completed / FAILED | Critical-pair Rs = 1.62 |
| 7 | BLANK_01 | Blank | Not started | Sequence held |
| 8–13 | SAMPLE_01–06 | Samples | Not started | Protected by sequence hold |
Approved Analytical Procedure
Method IDIMP-HPLC-042 Rev 7
ColumnC18, 150 × 4.6 mm
Flow1.000 mL/min
Detection254 nm
Column temperature35.0°C
SST materialQualified reference mixture
Method-specific SST requirements
| Parameter | Criterion | Current |
|---|---|---|
| Critical-pair resolution | ≥ 2.00 | 1.62 |
| Tailing factor | ≤ 2.00 | 1.28 |
| Theoretical plates | ≥ 3,000 | 6,870 |
| Standard area %RSD | ≤ 2.00% | 0.18% |
CDS Audit Trail
| Time | User | Event | Context |
|---|---|---|---|
| 07:42 | analyst.rk | Sequence template copied | Template: IMP_HPLC_042_R6_MONTHLY |
| 07:44 | analyst.rk | Acquisition method loaded | IMP_HPLC_042_R6 — column oven 30.0°C |
| 08:13 | analyst.rk | SST sequence started | 6 standard injections |
| 08:52 | system | Sequence gate failed | Critical-pair resolution below method criterion |
Instrument System Log
| Module | Current state | Last event |
|---|---|---|
| Pump | 1.000 mL/min • 126 bar | No alarms |
| Autosampler | Tray 1 • 8°C | No alarms |
| Column oven | 30.0°C stable | Setpoint loaded from acquisition method |
| UV detector | 254 nm | Lamp energy within internal check |