Iodine123NaIQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Iodine123NaIQualityChecker for Iodine-123 NaI.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Sodium Iodide I-123:
• • Radionuclidic purity (≥99% I-123)
• • Iodine-124 impurity (≤0.5%) — CRITICAL!
• • Iodine-125 impurity (≤0.5%)
• • Radiochemical purity (Iodide, ≥95%)
• • pH (7.0–10.0), endotoxins, sterility
• ⚠️ CRITICAL: I-124 impurity >0.5% is unacceptable! I-124 emits high-energy gamma rays and positrons, significantly increasing patient radiation dose without diagnostic benefit.
• BatchNumber,RadionuclidicPurityI123Percent,RadionuclidicImpurityI124Percent,RadionuclidicImpurityI125Percent,RadiochemicalPurityPercent,pH,EndotoxinsEU,SterilityTest,TotalActivityMBq,AppearanceScore
• Example (sterility: 0=sterile, 1=contaminated, appearance: 0=normal):
• ⚠️ CRITICAL:
• • Radionuclidic purity ≥99% — minimizes radiation dose from long-lived impurities.
• • I-124 impurity ≤0.5% — strict control of cyclotron production quality.
• • Radiochemical purity (Iodide) ≥95% — only I- form is actively transported into the thyroid.
• • Sterility and apyrogenicity — mandatory for oral or IV administration.

URS — User Requirements Specification

input.csv contract

BatchNumber,RadionuclidicPurityI123Percent,RadionuclidicImpurityI124Percent,RadionuclidicImpurityI125Percent,RadiochemicalPurityPercent,pH,EndotoxinsEU,SterilityTest,TotalActivityMBq,AppearanceScore
I123-NaI-2026-001,99.8,0.1,0.1,99.0,8.5,20.0,0,370.0,0
I123-NaI-2026-002,98.5,1.0,0.5,96.0,7.5,30.0,0,350.0,0

FS — Functional Specification

Example output.json

{
  "utilityId": "iodine123-na-i-quality-checker",
  "api": "Iodine-123 NaI",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "I123-NaI-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityI123Percent",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicImpurityI124Percent",
      "value": "0.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicImpurityI125Percent",
      "value": "0.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "99.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "8.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "20.0",
      "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.