Copper64DOTATATEQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Copper64DOTATATEQualityChecker for Copper-64 DOTATATE.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of [64Cu]Cu-DOTATATE:
• • Radionuclidic purity (≥99.9%)
• • Radiochemical purity (≥95%)
• • Free Copper-64 impurity (≤2.0%)
• • DOTATATE Ligand impurity (≤5.0%)
• • Specific activity (≥20 GBq/μmol)
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free Copper-64 >2.0% → high liver background, masking metastases!
• BatchNumber,RadionuclidicPurityPercent,RadiochemicalPurityPercent,FreeCopperPercent,DOTATATELigandImpurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,SpecificActivityGBqPerUmol
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — ensures specific tumor uptake
• • Free Copper ≤2.0% — free Cu-64 is taken up by the liver. Since the liver is a common site for NET metastases, high background can mask lesions (false negatives).
• • Specific activity ≥20 GBq/μmol — necessary to minimize peptide mass, avoiding pharmacological effects and receptor saturation

URS — User Requirements Specification

input.csv contract

BatchNumber,RadionuclidicPurityPercent,RadiochemicalPurityPercent,FreeCopperPercent,DOTATATELigandImpurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,SpecificActivityGBqPerUmol
CU64-DOTA-2026-001,99.98,98.2,0.8,1.0,7.0,40.0,0,3,35.0

FS — Functional Specification

Example output.json

{
  "utilityId": "copper64-dotatate-quality-checker",
  "api": "Copper-64 DOTATATE",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "CU64-DOTA-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.98",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeCopperPercent",
      "value": "0.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "DOTATATELigandImpurityPercent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "7.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "40.0",
      "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.