Copper64SarcophagineQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Copper64SarcophagineQualityChecker for Copper-64 Sarcophagine.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of [64Cu]Cu-Sarcophagine:
• • Radionuclidic purity (≥99.9%)
• • Radiochemical purity (≥98%)
• • Free Copper-64 impurity (≤1.0%)
• • Sarcophagine Ligand impurity (≤5.0%)
• • Specific activity (≥30 GBq/μmol)
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free Copper-64 >1.0% → sign of incomplete complexation!
• BatchNumber,RadionuclidicPurityPercent,RadiochemicalPurityPercent,FreeCopperPercent,SarcophagineLigandImpurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,SpecificActivityGBqPerUmol
• Example (sterility: 0=sterile, 1=contaminated):
• • Advantage: Absence of liver accumulation characteristic of free copper or less stable complexes (e.g., DOTATATE)
• ⚠️ CRITICAL:
• • Radiochemical purity ≥98% — due to high labeling efficiency, quality standards are higher than for open chelators
• • Free Copper ≤1.0% — strict limit, as even traces of free copper distort biodistribution

URS — User Requirements Specification

input.csv contract

BatchNumber,RadionuclidicPurityPercent,RadiochemicalPurityPercent,FreeCopperPercent,SarcophagineLigandImpurityPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,SpecificActivityGBqPerUmol
CU64-SAR-2026-001,99.99,99.2,0.3,0.5,7.1,25.0,0,1,45.0
CU64-SAR-2026-002,99.95,97.5,1.5,2.0,6.9,80.0,0,4,32.0
CU64-SAR-2026-003,99.90,98.5,0.8,1.2,7.4,10.0,0,2,55.0

FS — Functional Specification

Example output.json

{
  "utilityId": "copper64-sarcophagine-quality-checker",
  "api": "Copper-64 Sarcophagine",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "CU64-SAR-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.99",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "99.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeCopperPercent",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SarcophagineLigandImpurityPercent",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "7.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "25.0",
      "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.