Tc99mHMPAOBrainPerfusionStabilityChecker

Tc-99m HMPAO Brain Perfusion Stability Checker

api radiopharmaceuticals nuclear-medicine tc-99m spect brain-perfusion neurology
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Tc-99m HMPAO Brain Perfusion Stability Checker — Quality control of Tc-99m HMPAO stability

ℹ️ Utility checks critical stability parameters of Tc-99m HMPAO:

  • Lipophilic complex fraction (≥80%)
  • Time since preparation (<30 min)
  • Secondary hydrophilic complex (<20%)
  • Free technetium (<5%)

⚠️ CRITICAL: HMPAO rapidly converts to hydrophilic form!

Only lipophilic form crosses blood-brain barrier.

Drug must be administered within 30 minutes after preparation.

Usage

Tc99mHMPAOBrainPerfusionStabilityChecker.exe → demo mode (console output)

Tc99mHMPAOBrainPerfusionStabilityChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,SecondaryComplexPercent,FreeTechnetiumPercent,TimeSincePreparationMin,MaxAllowedTimeMin,pH,ActivityMBq,StorageCondition

Example

HMPAO-2026-001,82.0,10.0,5.0,15.0,30.0,7.4,700.0,RoomTemp

— WHY IS THIS NEEDED?

Tc-99m HMPAO (Ceretec) is drug for brain perfusion imaging.

  • Mechanism based on passive diffusion of lipophilic complex through BBB.
  • Inside brain cell, complex converts to hydrophilic form and gets "trapped".
  • However, outside cell, drug also rapidly converts to secondary hydrophilic complex that cannot enter brain.
  • This conversion occurs within 15-30 minutes after preparation.

⚠️ CRITICAL:

  • Radiochemical purity (lipophilic form) ≥80% — guarantee of brain penetration.
  • Time since preparation ≤30 minutes — critical stability factor.
  • Secondary complex <20% — indicator of drug degradation.
  • Free technetium <5% — minimization of background in thyroid and stomach.
  • pH 7.0-8.0 — solution stabilization.
  • Store at room temperature (do not refrigerate!).

Key features

  • Monitoring of drug "shelf-life after preparation".
  • Assessment of lipophilic form fraction, critical for diagnostics.
  • Warning about need for immediate administration.
  • Compliance with manufacturer and Pharmacopoeia requirements.

Critical parameters

  • Lipophilic form (RCP): ≥80.0%
  • Secondary complex: <20.0%
  • Free technetium: <5.0%
  • Time since preparation: ≤30 min
  • pH: 7.0–8.0

💡 Usage tips:

1. Prepare drug immediately before study.

2. Use TLC (acetone) for rapid RCP check before administration.

3. If more than 30 minutes have passed, drug is considered unsuitable for brain imaging.

4. Do not use drug if it has been refrigerated.

5. Administer drug as bolus to ensure clear first-pass circulation picture.

⚠️ Note: Unlike most radiopharmaceuticals, HMPAO stability is measured not in days but in minutes. This utility serves as strict timer and quality controller, preventing administration of degraded drug to patient, which would show only background in soft tissues but not in brain.

input.csv

BatchNumber,RadiochemicalPurityPercent,SecondaryComplexPercent,FreeTechnetiumPercent,TimeSincePreparationMin,MaxAllowedTimeMin,pH,ActivityMBq,StorageCondition
HMPAO-2026-001,82.0,10.0,5.0,15.0,30.0,7.4,700.0,RoomTemp
HMPAO-2026-002,75.0,18.0,4.0,35.0,30.0,7.2,650.0,RoomTemp
HMPAO-2026-003,60.0,30.0,8.0,45.0,30.0,7.0,600.0,RoomTemp

URS & FS — user requirements and functional specification

URS — User Requirements Specification

  • The utility shall accept input.csv with these mandatory columns: BatchNumber, RadiochemicalPurityPercent, SecondaryComplexPercent, FreeTechnetiumPercent, TimeSincePreparationMin, MaxAllowedTimeMin, pH, ActivityMBq, StorageCondition.
  • Each row shall be processed as a separate batch or record identified by BatchNumber.
  • Before evaluation, the utility shall validate the CSV structure, mandatory values, numeric fields and allowed text values.
  • Rules and limits shall be applied to every parameter in the input row.
  • Critical violations identified in the supplied description shall set the record result to FAIL.
  • Each row shall receive an overall PASS, WARNING or FAIL status with the triggered rules.
  • An invalid row shall not receive PASS.
  • output.json shall contain source values, applied limits, individual check results and errors.
  • The same input and the same rule profile shall produce the same result.

FS — Functional Specification

  1. Run Tc99mHMPAOBrainPerfusionStabilityChecker.exe in demonstration mode or with input.csv output.json arguments.
  2. Read UTF-8 CSV and verify the exact set of mandatory columns.
  3. Convert row values to numeric and text types.
  4. Apply the rules defined in the approved version or configuration profile.
  5. Generate individual check results and derive the overall status from the most severe violation.
  6. Write machine-readable output.json.
  7. Structural and type errors shall be reported explicitly and shall not be masked by a successful status.

Complete input.csv example

BatchNumber,RadiochemicalPurityPercent,SecondaryComplexPercent,FreeTechnetiumPercent,TimeSincePreparationMin,MaxAllowedTimeMin,pH,ActivityMBq,StorageCondition
HMPAO-2026-001,82.0,10.0,5.0,15.0,30.0,7.4,700.0,RoomTemp
HMPAO-2026-002,75.0,18.0,4.0,35.0,30.0,7.2,650.0,RoomTemp
HMPAO-2026-003,60.0,30.0,8.0,45.0,30.0,7.0,600.0,RoomTemp

Purpose of the supplied test rows

  • The first row contains values consistent with the criteria stated in the supplied description.
  • The second row contains values closer to the limits or moderate deviations.
  • The third row contains clear deviations for negative-result testing.

Minimum output.json structure

{
  "utility": "Tc99mHMPAOBrainPerfusionStabilityChecker",
  "source": "input.csv",
  "results": [
    {
      "batchNumber": "BATCH-001",
      "status": "PASS",
      "checks": [
        {
          "parameter": "ParameterName",
          "value": 0,
          "limit": "configured rule",
          "status": "PASS"
        }
      ],
      "errors": []
    }
  ]
}

Minimum OQ scenarios

  • Process the complete supplied input.csv.
  • Remove a mandatory column and confirm a contract error.
  • Provide text instead of a numeric value and confirm a type error.
  • Test values directly on the configured limits.
  • Repeat the run with the same input and confirm an identical result.

Before operational use

  • Reconcile rules and limits with the approved specification, methods and SOP.
  • Fix the executable version and rule-profile version.
  • Retain the source CSV together with the generated JSON.

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