Technetium99mExametazimeQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Technetium99mExametazimeQualityChecker for Tc-99m Exametazime.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Tc-99m HMPAO:
• • Radiochemical purity of lipophilic complex (≥80%)
• • Secondary complex (≤15%)
• • Free pertechnetate (≤5%)
• • Colloidal technetium (≤5%)
• • pH, endotoxins, sterility
• ⚠️ CRITICAL: HMPAO is extremely unstable. After 30 minutes, most of the drug
• BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,SecondaryComplexPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,TimeSinceReconstitutionMin,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical Purity (Lipophilic complex) ≥80% — ONLY the lipophilic form crosses biological barriers (BBB or cell membrane). If purity is lower, the drug will not reach the target.
• • Secondary complex ≤15% — HMPAO spontaneously degrades into a secondary hydrophilic complex even in the vial. This complex DOES NOT cross the BBB. For WBC labeling it is less critical, but for brain it is crucial.
• • TEMPORAL STABILITY (≤30 min) — THE MOST IMPORTANT PARAMETER. The drug must be used (administered to patient or added to WBCs) within 30 minutes after reconstitution. After this time, the fraction of lipophilic complex falls below acceptable levels.
• • Free pertechnetate ≤5% — Accumulates in thyroid gland, salivary glands, and stomach.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,SecondaryComplexPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,TimeSinceReconstitutionMin,ProductType
TC99M-HMPAO-2026-070,740.0,86.0,9.0,3.0,2.0,7.4,20.0,0,15,CerebralPerfusion
TC99M-HMPAO-WBC-071,500.0,82.0,12.0,4.0,2.0,7.2,15.0,0,20,WBCLabeling
TC99M-HMPAO-FAIL-072,700.0,60.0,35.0,3.0,2.0,7.5,25.0,0,45,CerebralPerfusion

FS — Functional Specification

Example output.json

{
  "utilityId": "technetium99m-exametazime-quality-checker",
  "api": "Tc-99m Exametazime",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TC99M-HMPAO-2026-070",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "740.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "86.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SecondaryComplexPercent",
      "value": "9.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreePertechnetatePercent",
      "value": "3.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ReducedHydrolyzedTcPercent",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "7.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "20.0",
      "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.