Iodine131LipiodolQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Iodine131LipiodolQualityChecker for Iodine-131 Lipiodol.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Iodine-131 Lipiodol:
• • Radionuclidic purity (≥99.9%)
• • Iodine-125 impurity (≤0.1%)
• • Radiochemical purity (≥95%) — binding to lipiodol
• • Free iodide (≤5%)
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free iodide >5% → accumulation in thyroid and stomach!
• Radiochemical purity <95% → risk of non-target embolization and systemic toxicity!
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Iodine125ImpurityPercent,RadiochemicalPurityPercent,FreeIodidePercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — Iodine must be firmly bound to lipiodol. Free iodine washes out quickly and accumulates in the thyroid (if not blocked) and gastric mucosa.
• • Iodine-125 impurity ≤0.1% — I-125 (T½=59.4 days) creates unnecessary long-term radiation burden without therapeutic beta effect.
• • Free iodide ≤5% — high levels of free iodide lead to systemic toxicity and reduced tumor dose.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Iodine125ImpurityPercent,RadiochemicalPurityPercent,FreeIodidePercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
I131-LIP-2026-001,3700.0,99.95,0.02,98.5,1.2,6.0,50.0,0,2,Therapeutic
I131-LIP-2026-002,3500.0,99.80,0.15,94.0,6.5,5.5,180.0,0,8,Therapeutic
I131-LIP-2026-003,3800.0,99.99,0.01,99.0,0.5,6.2,40.0,0,1,Diagnostic

FS — Functional Specification

Example output.json

{
  "utilityId": "iodine131-lipiodol-quality-checker",
  "api": "Iodine-131 Lipiodol",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "I131-LIP-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "3700.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.95",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Iodine125ImpurityPercent",
      "value": "0.02",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeIodidePercent",
      "value": "1.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "50.0",
      "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.