Indium111CapromabPendetideChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Indium111CapromabPendetideChecker for Indium-111 Capromab Pendetide.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of the monoclonal antibody-based radiopharmaceutical:
• • Radiochemical purity (≥90%)
• • Free Indium-111 impurity (≤5%)
• • Colloidal Indium-111 impurity (≤5%)
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free Indium-111 accumulates in bone marrow and liver!
• BatchNumber,RadiochemicalPurityPercent,FreeIndium111Percent,ColloidalIndium111Percent,SpecificActivityMBqPerMg,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProteinConcentrationMgPerMl
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥90% — ensures most activity is bound to the antibody and reaches the target.
• • Free Indium-111 ≤5% — unbound indium accumulates in bone marrow, mimicking or hiding metastases.
• • Colloidal Indium-111 ≤5% — hydrolyzed indium is taken up by liver and spleen, creating high abdominal background.
• • pH 6.0–7.5 — critical for antibody stability and injection compatibility.
• • Endotoxins ≤350 EU/vial — safety standard for parenterals.

URS — User Requirements Specification

input.csv contract

BatchNumber,RadiochemicalPurityPercent,FreeIndium111Percent,ColloidalIndium111Percent,SpecificActivityMBqPerMg,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProteinConcentrationMgPerMl
IN111-CP-2026-001,96.5,1.5,2.0,185.0,6.8,120.0,0,4,1.0
IN111-CP-2026-002,88.0,8.0,4.0,190.0,6.5,110.0,0,5,1.0

FS — Functional Specification

Example output.json

{
  "utilityId": "indium111-capromab-pendetide-checker",
  "api": "Indium-111 Capromab Pendetide",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "IN111-CP-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "96.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeIndium111Percent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ColloidalIndium111Percent",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SpecificActivityMBqPerMg",
      "value": "185.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "120.0",
      "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.