URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of I131Iobenguane_CommercialRadioligandProductMap for I.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of I-131 MIBG radiopharmaceutical:
• • Total Activity: Within specification
• • Radiochemical Purity: ≥95.0%
• • Free Iodide-131: ≤5.0%
• • Chemical Purity: ≥98.0%
• • Endotoxins: ≤175 EU/mL
• • Sterility: Mandatory
• ⚠️ CRITICAL: High level of free iodide leads to accumulation in the thyroid gland.
• Radiochemical purity is critical for image quality and radiation dose.
• BatchNumber,TotalActivityMBq,RCP,FreeIodide,ChemPurity,pH,Endotoxins,Sterility,SpecificActivity
• Example (sterility: 0=sterile):
• • Free iodide is the main impurity formed during radiolysis
• ⚠️ CRITICAL:
• • Radiochemical Purity ≥95.0% — ensures radionuclide delivery to target
• • Free Iodide-131 ≤5.0% — critical! Accumulation in thyroid causes radiation damage
• • Chemical Purity ≥98.0% — absence of toxic chemical impurities
• • pH 4.0–7.0 — product stability and blood compatibility
• • Endotoxins ≤175 EU/mL — safety for IV administration

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RCP,FreeIodide,ChemPurity,pH,Endotoxins,Sterility,SpecificActivity
I131-MIBG-2026-001,3700.0,98.5,1.2,99.5,5.5,50.0,0,50.0
I131-MIBG-2026-002,3500.0,96.0,3.5,99.0,6.0,40.0,0,45.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "i-131-iobenguane-commercial-radioligand-product-map",
  "utilityFolder": "I131Iobenguane_CommercialRadioligandProductMap",
  "package": "Global/API coverage extension",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "I131-MIBG-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "3700.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "RCP",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "FreeIodide",
      "value": "1.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "ChemPurity",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "pH",
      "value": "5.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "Endotoxins",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "Sterility",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "SpecificActivity",
      "value": "50.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "I131Iobenguane_CommercialRadioligandProductMap.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating validator, documentation 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 limits shall be verified against the approved specification, registration dossier and local SOPs.
• For combination products, document whether the specialized FDC utility or fallback component checks were used.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.