URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Lu177DotatateVariants_CommercialRadioligandProductMap for Lu.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of lutetium-177 dotatate:
• • Radiochemical purity (≥95%)
• • Free Lu-177 (≤2%)
• • Colloidal Lu-177 (≤1%)
• • Specific activity (≥40 GBq/μmol)
• • Endotoxins (≤175 EU/vial)
• • Sterility
• • Radionuclidic purity (≥99.9%)
• • Lu-177m impurity (≤0.05%)
• ⚠️ CRITICAL: Free Lu-177 accumulates in bone marrow!
• BatchNumber,CommercialProduct,RadiochemicalPurityPercent,FreeLu177Percent,ColloidalLu177Percent,SpecificActivityGBqPerUmol,pH,EndotoxinsEUPerVial,SterilityTest,RadionuclidicPurityPercent,Lu177mImpurityPercent
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — ensures radiation delivery to tumor cells
• • Free Lu-177 ≤2% — UNBOUND lutetium accumulates in BONE MARROW, causing myelosuppression!
• • Colloidal Lu-177 ≤1% — COLLOIDS accumulate in liver and spleen, causing toxicity!
• • Specific activity ≥40 GBq/μmol — ensures sufficient therapeutic dose
• • pH 3.5-5.5 — critical for complex stability and blood compatibility

URS — User Requirements Specification

input.csv contract

BatchNumber,CommercialProduct,RadiochemicalPurityPercent,FreeLu177Percent,ColloidalLu177Percent,SpecificActivityGBqPerUmol,pH,EndotoxinsEUPerVial,SterilityTest,RadionuclidicPurityPercent,Lu177mImpurityPercent
LU177-DOTA-2026-001,Lutathera,99.2,0.5,0.3,55.0,4.5,45.0,0,99.95,0.02
LU177-DOTA-2026-002,Generic,97.8,1.2,0.5,48.0,4.2,80.0,0,99.92,0.03
LU177-DOTA-2026-003,Custom,96.5,1.8,0.8,42.0,4.8,120.0,0,99.90,0.04

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "lu-177-dotatate-variants-commercial-radioligand-product-map",
  "utilityFolder": "Lu177DotatateVariants_CommercialRadioligandProductMap",
  "package": "Cardiology QC Suite",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "LU177-DOTA-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "CommercialProduct",
      "value": "Lutathera",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "99.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "FreeLu177Percent",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "ColloidalLu177Percent",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "SpecificActivityGBqPerUmol",
      "value": "55.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "pH",
      "value": "4.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "EndotoxinsEUPerVial",
      "value": "45.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "SterilityTest",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.95",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "Lu177mImpurityPercent",
      "value": "0.02",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "Lu177DotatateVariants_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.