Technetium99mGlucoheptonateChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Technetium99mGlucoheptonateChecker for Tc-99m Glucoheptonate.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Tc-99m Glucoheptonate:
• • Radiochemical purity (≥90%)
• • Free pertechnetate (≤5%)
• • Colloidal technetium (≤5%)
• • pH (4.0–7.0), endotoxins, sterility
• ⚠️ ADVANTAGE: High stability (6 hours) compared to HMPAO.
• BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,TimeSinceReconstitutionMin,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥90% — Low RCP leads to free pertechnetate (thyroid/stomach background) and colloid (liver background). For brain imaging, this is critical as background can mask pathological foci.
• • Free pertechnetate ≤5% — Creates artifacts in neck and chest area.
• • Reduced/Hydrolyzed Tc ≤5% — Accumulates in liver and spleen. In renal scintigraphy, the right kidney is close to the liver, so high colloid background interferes with diagnosis.
• • TEMPORAL STABILITY (≤6 hours) — The drug is stable at room temperature for 6 hours after reconstitution. This is much more convenient than HMPAO (30 min).
• • Endotoxins ≤175 EU/vial, Sterility — standard requirements.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,TimeSinceReconstitutionMin,ProductType
TC99M-GH-2026-080,740.0,96.0,2.5,1.5,5.5,15.0,0,60,BrainRenal
TC99M-GH-OLD-081,700.0,88.0,8.0,4.0,5.8,20.0,0,400,BrainRenal
TC99M-GH-FAIL-082,720.0,85.0,10.0,5.0,7.5,10.0,0,30,BrainRenal

FS — Functional Specification

Example output.json

{
  "utilityId": "technetium99m-glucoheptonate-checker",
  "api": "Tc-99m Glucoheptonate",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TC99M-GH-2026-080",
      "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": "96.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreePertechnetatePercent",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ReducedHydrolyzedTcPercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "5.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "15.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SterilityTest",
      "value": "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.