Tc99mMAG3QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Tc99mMAG3QualityChecker for Tc-99m MAG3.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Tc-99m MAG3:
• • Radiochemical purity (≥90%)
• • Free pertechnetate (≤5%)
• • Colloidal technetium (≤5%)
• • Boiling time control (10 min) — CRITICAL!
• • pH, endotoxins, sterility
• ⚠️ CRITICAL: Insufficient boiling time (<10 min) leads to low labeling yield.
• BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,ReactionTimeMin,CoolingTimeMin,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥90% — Low RCP leads to free pertechnetate (stomach/thyroid background) and colloid (liver background), distorting clearance calculation and imaging.
• • Free pertechnetate ≤5% — Creates artifacts and increases radiation dose.
• • Reduced/Hydrolyzed Tc ≤5% — Accumulates in liver, which is anatomically close to the right kidney, interfering with analysis.
• • pH 7.0–8.5, Endotoxins ≤175 EU/vial, Sterility — standard requirements.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,ReactionTimeMin,CoolingTimeMin,ProductType
TC99M-MAG3-2026-022,370.0,96.5,2.0,1.5,7.5,15.0,0,10.0,5.0,RenalImaging
TC99M-MAG3-FAIL-023,350.0,85.0,10.0,5.0,7.2,20.0,0,8.0,5.0,RenalImaging
TC99M-MAG3-OK-024,400.0,94.0,3.0,3.0,7.8,10.0,0,12.0,10.0,RenalImaging

FS — Functional Specification

Example output.json

{
  "utilityId": "tc99m-mag3-quality-checker",
  "api": "Tc-99m MAG3",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TC99M-MAG3-2026-022",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "370.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "96.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreePertechnetatePercent",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ReducedHydrolyzedTcPercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "7.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "15.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SterilityTest",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator and test set.
• Retain input.csv, output.json, executable version and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical radiopharmaceutical limits must be verified against the approved specification and local SOPs.