PQS QC Laboratory • Assay Room 2
0.0000 g
STD
SMP-A
SMP-B
25:00 min
24.8°C
24.8°C
QUATERNARY PUMP
1.000 mL/min
128 bar
stable128 bar
AUTOSAMPLER
TRAY 1
10 µL
ready10 µL
COLUMN OVEN
30.0°C
C18
stableC18
UV DETECTOR
254 nm
LAMP ON
readyLAMP ON
Analytical Job — Finished Product Assay
ProductPQS-IR 100 mg Tablets
BatchB260904-17
Specification95.0–105.0%
MethodASSAY-HPLC-018 Rev 5
Sample receipt record
| Item | Recorded information | Status |
|---|---|---|
| Sample ID | FP-B260904-17-ASSAY | Matched |
| Container seal | Seal 44187 intact | Accepted |
| Quantity received | 30 tablets | Sufficient |
| Storage before test | Controlled room temperature | Acceptable |
Standard & Sample Preparation Record
Reference standardAPI RS Lot RS-26-041 • Potency 99.4% as-is
Standard weight25.20 mg → 250.0 mL
Tablet average weight250.0 mg/tablet
Sample powder weight62.50 mg → 250.0 mL
ExtractionSonicate 25 min; cool; dilute to volume
Filtration0.45 µm membrane; discard first 2 mL per method
Potency-corrected standard concentration = (25.20 mg × 0.994) / 250.0 mL = 0.100195 mg/mL
Approved Method & System Suitability
ColumnC18, 150 × 4.6 mm, 5 µm
Mobile phaseBuffer : Acetonitrile = 60 : 40
Flow / temperature1.0 mL/min • 30°C
Detection / injection254 nm • 10 µL
Scenario-specific SST criteria
| Parameter | Method criterion | Current |
|---|---|---|
| Standard area %RSD (n=6) | ≤ 1.0% | 0.21% |
| Tailing factor | ≤ 2.0 | 1.22 |
| Theoretical plates | ≥ 4,000 | 8,540 |
| Blank carryover | ≤ 0.05% of standard response | 0.01% |
Training note: these numerical limits belong only to fictional method ASSAY-HPLC-018 Rev 5 and are not universal HPLC requirements.
CDS Sequence
| # | Injection | Type | Status | Result / note |
|---|---|---|---|---|
| 1 | BLK_01 | Blank | Queued | Pre-run blank |
| 2–7 | STD_01–06 | Reference standard | Queued | SST set |
| 8 | BLK_02 | Carryover blank | Queued | After standard |
| 9 | SMP_A | Sample preparation A | Queued | Assay |
| 10 | SMP_B | Sample preparation B | Queued | Assay |
| 11 | STD_BRACKET | Bracketing standard | Queued | Sequence verification |
Chromatogram Review
Standard area mean1,250,420
Sample A area1,230,110
Sample B area1,231,060
Peak integrationAutomatic / unchanged
Assay Calculation Workspace
Standard concentration0.100195 mg/mL
Sample nominal concentration0.100000 mg/mL
Sample A assay98.61%
Sample B assay98.69%
Assay % = (Sample peak area / Standard mean peak area) × (Cstd / Csmp) × 100
Mean assay = 98.65% of label claim
CDS Audit Trail & Review History
| Time | User | Event | Review meaning |
|---|---|---|---|
| 09:04 | analyst.ma | Sequence created from controlled template | Traceable |
| 09:07 | analyst.ma | Approved method ASSAY-HPLC-018-R5 loaded | Correct version |
| 09:12 | analyst.ma | Sequence saved | No post-acquisition edit |
| — | — | No chromatographic processing changes yet | No red flag |