Tc99mSestamibiCardiacQualityChecker

Tc-99m Sestamibi Cardiac Quality Checker

api radiopharmaceuticals nuclear-medicine tc-99m spect myocardial-perfusion cardiology

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Tc-99m Sestamibi Cardiac Quality Checker — Quality control of Tc-99m Sestamibi for cardiology

ℹ️ Utility checks critical parameters of Tc-99m Sestamibi:

Radiochemical purity (≥90%)
Free technetium (<5%)
Colloidal technetium (<5%)
Heating process, pH, shelf-life

⚠️ CRITICAL: Sestamibi requires heating for complex formation!

Tc-99m Sestamibi is gold standard for myocardial perfusion scintigraphy.

Uptake depends on mitochondrial membrane potential.

Usage

Tc99mSestamibiCardiacQualityChecker.exe → demo mode (console output)

Tc99mSestamibiCardiacQualityChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,FreeTechnetiumPercent,HydrolyzedReducedTcPercent,pH,TimeSincePreparationMin,ActivityMBq,SterilityTest,EndotoxinsEU_per_mL,HeatingCondition

Example

SEST-2026-001,97.0,2.0,1.0,6.5,45.0,1000.0,0,10.0,Passed

— WHY IS THIS NEEDED?

Tc-99m Sestamibi (MIBI) is drug for myocardial perfusion imaging.

Mechanism: passive diffusion through cell membrane and binding to mitochondria.
Requires heating during preparation to form cationic complex.
Free technetium gives background in thyroid and stomach.
Colloidal technetium gives background in liver, which may interfere with inferior wall assessment.

⚠️ CRITICAL:

Radiochemical purity ≥90% (recommended >95%) — guarantee of high myocardial uptake.
Free technetium <5% — minimization of artifacts.
Colloidal technetium <5% — critical for excluding liver overlap.
Heating process must be performed strictly according to protocol.
pH 5.0-7.0 — complex stability.
Time since preparation ≤6 hours — in vitro stability limit.
Endotoxins <175 EU/mL — standard for parenteral drugs.
Sterility — MANDATORY.

Key features

Control of heating process as critical synthesis step.
Separate control of free and colloidal technetium.
Drug shelf-life monitoring.
Suitability assessment for cardiac diagnostics.
Compliance with Pharmacopoeia requirements for Tc-99m radiopharmaceuticals.

Critical parameters

Radiochemical purity: ≥90.0%
Free technetium: <5.0%
Colloidal technetium: <5.0%
Heating: Passed
pH: 5.0–7.0
Time since preparation: ≤360 min (6 h)
Endotoxins: <175 EU/mL
Sterility: no growth

💡 Usage tips:

1. Radiochemical purity determined by TLC (two solvents).

2. Heat vial for exactly specified time (usually 10 min at 100°C).

3. Allow drug to cool to room temperature before administration.

4. Use drug within 4-6 hours after preparation.

5. Sestamibi is stable at room temperature, but protect from light.

⚠️ Note: Tc-99m Sestamibi is one of most reliable drugs for assessing myocardial viability. However, its quality strongly depends on compliance with preparation technology (heating). This utility guarantees that complex formed correctly and is ready for coronary artery disease diagnostics.

input.csv

BatchNumber,RadiochemicalPurityPercent,FreeTechnetiumPercent,HydrolyzedReducedTcPercent,pH,TimeSincePreparationMin,ActivityMBq,SterilityTest,EndotoxinsEU_per_mL,HeatingCondition
SEST-2026-001,97.0,2.0,1.0,6.5,45.0,1000.0,0,10.0,Passed
SEST-2026-002,92.0,4.0,4.0,6.8,120.0,900.0,0,15.0,Passed
SEST-2026-003,85.0,8.0,7.0,7.5,400.0,800.0,1,20.0,Failed

URS & FS — user requirements and functional specification

URS — User Requirements Specification

The utility shall accept input.csv with these mandatory columns: BatchNumber, RadiochemicalPurityPercent, FreeTechnetiumPercent, HydrolyzedReducedTcPercent, pH, TimeSincePreparationMin, ActivityMBq, SterilityTest, EndotoxinsEU_per_mL, HeatingCondition.
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

Run Tc99mSestamibiCardiacQualityChecker.exe in demonstration mode or with input.csv output.json arguments.
Read UTF-8 CSV and verify the exact set of mandatory columns.
Convert row values to numeric and text types.
Apply the rules defined in the approved version or configuration profile.
Generate individual check results and derive the overall status from the most severe violation.
Write machine-readable output.json.
Structural and type errors shall be reported explicitly and shall not be masked by a successful status.

Complete input.csv example

BatchNumber,RadiochemicalPurityPercent,FreeTechnetiumPercent,HydrolyzedReducedTcPercent,pH,TimeSincePreparationMin,ActivityMBq,SterilityTest,EndotoxinsEU_per_mL,HeatingCondition
SEST-2026-001,97.0,2.0,1.0,6.5,45.0,1000.0,0,10.0,Passed
SEST-2026-002,92.0,4.0,4.0,6.8,120.0,900.0,0,15.0,Passed
SEST-2026-003,85.0,8.0,7.0,7.5,400.0,800.0,1,20.0,Failed

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": "Tc99mSestamibiCardiacQualityChecker",
  "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.

Included in packages

Cardiology QC Suite

QC package for cardiology medicines: antihypertensives, anticoagulants, antiplatelets, lipid-lowering and antiarrhythmic medicines plus supporting QC checks.

Tc99mSestamibiCardiacQualityChecker