Lutetium177DOTATOCQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Lutetium177DOTATOCQualityChecker for Lutetium-177 DOTATOC.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Lutetium-177 DOTATOC:
• • Radionuclidic purity (≥99.9%)
• • Lutetium-177m impurity (≤0.01%)
• • Radiochemical purity (≥95%) — binding to DOTATOC
• • Free lutetium (≤5%)
• • Precursor peptide (≤10%)
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free lutetium >5% → accumulation in bone marrow and liver!
• Lu-177m impurity >0.01% → long-term radiation burden due to 160.4-day half-life!
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Lutetium177mImpurityPercent,RadiochemicalPurityPercent,FreeLutetiumPercent,PrecursorPeptidePercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — Lutetium must be firmly chelated by DOTATOC. Free lutetium accumulates in bones and liver, causing bone marrow toxicity.
• • Lutetium-177m impurity ≤0.01% — Lu-177m (T½=160.4 days) is a metastable isomer with a long half-life, creating unnecessary long-term radiation burden.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Lutetium177mImpurityPercent,RadiochemicalPurityPercent,FreeLutetiumPercent,PrecursorPeptidePercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
Lu177-DOTATOC-2026-001,7400.0,99.99,0.005,98.5,1.0,5.0,5.5,40.0,0,2,Therapeutic
Lu177-DOTATOC-2026-002,7200.0,99.85,0.02,94.0,6.5,12.0,5.0,180.0,0,8,Therapeutic
Lu177-DOTATOC-2026-003,7500.0,99.95,0.008,99.0,0.5,2.0,6.0,20.0,0,1,Therapeutic

FS — Functional Specification

Example output.json

{
  "utilityId": "lutetium177-dotatoc-quality-checker",
  "api": "Lutetium-177 DOTATOC",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "Lu177-DOTATOC-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": "99.99",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Lutetium177mImpurityPercent",
      "value": "0.005",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeLutetiumPercent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "PrecursorPeptidePercent",
      "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.