Iodine131MIBGQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Iodine131MIBGQualityChecker for Iodine-131 MIBG.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Iodine-131 MIBG:
• • Radionuclidic purity (≥99.9%)
• • Iodine-125 impurity (≤0.1%)
• • Radiochemical purity (≥95%) — binding to MIBG
• • Free iodide (≤5%)
• • Precursor MIBG (≤10%)
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free iodide >5% → accumulation in thyroid!
• Radiochemical purity <95% → reduced therapeutic effect and healthy tissue irradiation!
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Iodine125ImpurityPercent,RadiochemicalPurityPercent,FreeIodidePercent,PrecursorMIBGPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — MIBG must be firmly bound to I-131. Free iodine washes out quickly and accumulates in the thyroid (risk of hypothyroidism/thyroid cancer).
• • Iodine-125 impurity ≤0.1% — I-125 (T½=59.4 days) creates unnecessary long-term radiation burden without therapeutic beta effect.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Iodine125ImpurityPercent,RadiochemicalPurityPercent,FreeIodidePercent,PrecursorMIBGPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
I131-MIBG-2026-001,7400.0,99.98,0.01,98.0,1.5,5.0,5.5,40.0,0,3,Therapeutic
I131-MIBG-2026-002,7200.0,99.85,0.12,94.5,6.0,12.0,5.0,180.0,0,8,Therapeutic
I131-MIBG-2026-003,370.0,99.99,0.005,99.0,0.5,2.0,6.0,20.0,0,1,Diagnostic

FS — Functional Specification

Example output.json

{
  "utilityId": "iodine131-mibg-quality-checker",
  "api": "Iodine-131 MIBG",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "I131-MIBG-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "7400.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.98",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Iodine125ImpurityPercent",
      "value": "0.01",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeIodidePercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "PrecursorMIBGPercent",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "5.5",
      "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.