Iodine123MIBGQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Iodine123MIBGQualityChecker for Iodine-123 MIBG.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Iodine-123 MIBG radiopharmaceutical:
• • Radiochemical purity (≥95%)
• • Free Iodine-123 impurity (≤5%)
• • Radionuclidic impurity Iodine-124 (≤0.5%)
• • Radionuclidic impurity Iodine-125 (≤0.5%)
• • Specific activity, pH (4.0–6.0), endotoxins, sterility
• ⚠️ CRITICAL: Free iodine accumulates in the thyroid, stomach, and salivary glands, creating high background and artifacts.
• I-124 impurity (>0.5%) significantly increases patient radiation dose due to high-energy emissions.
• BatchNumber,RadiochemicalPurityPercent,FreeIodine123Percent,RadionuclidicPurityI124Percent,RadionuclidicPurityI125Percent,SpecificActivityMBqPerUg,pH,EndotoxinsEU,SterilityTest,AppearanceScore
• Example (sterility: 0=sterile, 1=contaminated, appearance: 0=normal):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — ensures specific uptake by target tissues.
• • Free Iodine-123 ≤5% — requires mandatory thyroid blocking with potassium iodide prior to administration.
• • I-124 impurity ≤0.5% — control of cyclotron production quality.

URS — User Requirements Specification

input.csv contract

BatchNumber,RadiochemicalPurityPercent,FreeIodine123Percent,RadionuclidicPurityI124Percent,RadionuclidicPurityI125Percent,SpecificActivityMBqPerUg,pH,EndotoxinsEU,SterilityTest,AppearanceScore
I123-MIBG-2026-001,98.0,1.5,0.2,0.1,25.0,5.5,60.0,0,0
I123-MIBG-2026-002,94.0,5.5,0.6,0.2,20.0,5.8,70.0,0,0

FS — Functional Specification

Example output.json

{
  "utilityId": "iodine123-mibg-quality-checker",
  "api": "Iodine-123 MIBG",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "I123-MIBG-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeIodine123Percent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityI124Percent",
      "value": "0.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityI125Percent",
      "value": "0.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SpecificActivityMBqPerUg",
      "value": "25.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "5.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "60.0",
      "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.