Mercury197QualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Mercury197QualityChecker for Mercury-197.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Mercury-197:
• • Radionuclidic purity (≥99.0%)
• • Mercury-197m impurity (≤1.0%)
• • Mercury-203 impurity (≤0.1%)
• • Radiochemical purity (≥95%)
• • Free mercury (≤2%)
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free mercury >2% → NEPHROTOXICITY!
• Hg-203 impurity >0.1% → long-term toxicity and radiation burden!
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Mercury197mImpurityPercent,Mercury203ImpurityPercent,RadiochemicalPurityPercent,FreeMercuryPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Free mercury ≤2% — Inorganic mercury is highly nephrotoxic. Even small amounts of free mercury can cause renal tubular damage.
• • Mercury-203 impurity ≤0.1% — Hg-203 (T½=46.6 days) is a beta and gamma emitter with a long half-life. Its presence is unacceptable due to high patient dose and long-term environmental contamination.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Mercury197mImpurityPercent,Mercury203ImpurityPercent,RadiochemicalPurityPercent,FreeMercuryPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
Hg197-RENAL-2026-001,37.0,99.5,0.5,0.05,98.0,1.0,6.5,40.0,0,2,Renal_Imaging
Hg197-RENAL-2026-002,35.0,98.5,1.5,0.2,94.0,3.0,6.0,180.0,0,8,Renal_Imaging
Hg197-RES-2026-001,50.0,99.8,0.2,0.02,99.0,0.5,7.0,20.0,0,1,Research

FS — Functional Specification

Example output.json

{
  "utilityId": "mercury197-quality-checker",
  "api": "Mercury-197",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "Hg197-RENAL-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "37.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Mercury197mImpurityPercent",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Mercury203ImpurityPercent",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreeMercuryPercent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.5",
      "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.