Platinum195mQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Platinum195mQualityChecker for Platinum-195m.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Platinum-195m:
• • Radionuclidic purity (≥99.0%)
• • Pt-191 and Pt-193m impurities (≤0.5% each)
• • Radiochemical purity (≥95%)
• • Free platinum (≤5%) — NEPHROTOXICITY!
• • pH, endotoxins, sterility, heavy metals
• ⚠️ CRITICAL: Free platinum is highly toxic to kidneys and auditory nerve!
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Platinum191ImpurityPercent,Platinum193mImpurityPercent,RadiochemicalPurityPercent,FreePlatinumPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• • FreeIon — biodistribution studies
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% — ensures platinum is in the form of the desired drug (e.g., cisplatin), not degraded forms.
• • Free platinum ≤5% — IONIC PLATINUM (unbound to ligand) is extremely nephrotoxic and ototoxic. It is rapidly excreted by kidneys, damaging tubules. Control of free platinum is a patient safety issue!
• • Radionuclidic purity ≥99.0% — impurities Pt-191 (T½=2.8 d) and Pt-193m (T½=4.33 d) create additional radiation background and distort quantitative imaging.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Platinum191ImpurityPercent,Platinum193mImpurityPercent,RadiochemicalPurityPercent,FreePlatinumPercent,pH,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,ProductType
PT195M-CIS-2026-001,500.0,99.5,0.2,0.3,98.0,2.0,6.0,50.0,0,2,CisplatinAnalog
PT195M-NANO-2026-002,300.0,98.5,1.0,0.5,96.0,4.0,6.5,100.0,0,5,Nanoparticle
PT195M-FREE-2026-003,100.0,99.9,0.05,0.05,99.5,0.5,5.5,20.0,0,1,FreeIon

FS — Functional Specification

Example output.json

{
  "utilityId": "platinum195m-quality-checker",
  "api": "Platinum-195m",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "PT195M-CIS-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "500.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Platinum191ImpurityPercent",
      "value": "0.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Platinum193mImpurityPercent",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreePlatinumPercent",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.0",
      "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.