Indium111PentetreotideQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Indium111PentetreotideQualityChecker for Indium-111 Pentetreotide.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of the somatostatin analog radiopharmaceutical:
• • Radiochemical purity (≥90%)
• • Free Indium-111 impurity (≤5%)
• • Colloidal Indium-111 impurity (≤5%)
• • pH (4.0–6.0), endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free Indium-111 accumulates in bone marrow and liver!
• BatchNumber,RadiochemicalPurityPercent,FreeIndium111Percent,ColloidalIndium111Percent,SpecificActivityMBqPerUg,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,PeptideConcentrationUgPerVial
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥90% — ensures specific binding to the tumor.
• • Free Indium-111 ≤5% — unbound indium gives signal in bones and liver.
• • Colloidal Indium-111 ≤5% — hydrolyzed indium is taken up by liver and spleen, which is critical as many NETs are located in this area.
• • Endotoxins ≤175 EU/vial — safety standard.
• • Sterility — MANDATORY!

URS — User Requirements Specification

input.csv contract

BatchNumber,RadiochemicalPurityPercent,FreeIndium111Percent,ColloidalIndium111Percent,SpecificActivityMBqPerUg,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,PeptideConcentrationUgPerVial
IN111-PEN-2026-001,94.5,2.5,3.0,45.0,5.2,80.0,0,3,50.0
IN111-PEN-2026-002,89.0,6.0,5.0,42.0,5.5,90.0,0,4,50.0

FS — Functional Specification

Example output.json

{
  "utilityId": "indium111-pentetreotide-quality-checker",
  "api": "Indium-111 Pentetreotide",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "IN111-PEN-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "94.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeIndium111Percent",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ColloidalIndium111Percent",
      "value": "3.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SpecificActivityMBqPerUg",
      "value": "45.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "5.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "80.0",
      "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.