Tc99mMertiatideKineticStabilityChecker

Utility description: Tc-99m Mertiatide (MAG3) Kinetic Stability Checker

Tc-99m Mertiatide (MAG3) Kinetic Stability Checker — Kinetic stability analysis of Technetium-99m MAG3

ℹ️  Utility evaluates MAG3 complex stability over time:
    • Radiochemical purity (RCP) drop over 4 and 8 hours
    • Transchelation rate (transfer to proteins)
    • Impact of storage conditions (temperature, light)

⚠️  CRITICAL: MAG3 is prone to isomer formation and oxidation!
    Rapid RCP drop leads to liver accumulation instead of kidneys.
    Transchelation >0.5%/h is unacceptable for clinical use.

Usage:
  Tc99mMertiatideKineticStabilityChecker.exe                            → demo mode (console output)
  Tc99mMertiatideKineticStabilityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,InitialRCP_Percent,RCP_After4Hours,RCP_After8Hours,TranschelationPercent_4h,TranschelationPercent_8h,StorageTemperatureC,LightProtected,pH_At_T0

Example (LightProtected: true/false):
  MAG3-KIN-2026-001,98.5,97.8,96.5,1.0,2.5,20.0,true,6.2

— WHY IS THIS NEEDED?
Unlike DTPA, Tc-99m MAG3 complex is thermodynamically less stable and kinetically inert only under certain conditions.
• Over time, complex dissociation may occur with release of free technetium.
• Transchelation — transfer of technetium ion to endogenous ligands (e.g., albumin or transferrin) in solution or in vivo — is possible.
• Formation of MAG3 isomers may reduce tubular secretion efficiency.
• Kinetic control allows determining the real shelf life of the prepared drug (usually 6-8 hours).

⚠️  CRITICAL:
• RCP drop should not exceed 3% over 8 hours of storage.
• Transchelation rate must be minimal (<0.5% per hour). High rate indicates ligand defect or excess tin.
• Light accelerates photooxidation of Sn(II) and complex destruction, so storage must be in the dark.
• Temperatures above 25°C accelerate all degradation processes.

Key features:
• Calculation of complex degradation rate over time (kinetic rate).
• Transchelation risk assessment based on chromatography data.
• Consideration of environmental factors (light, temperature).
• Prediction of drug suitability at the end of the working day.
• Compliance with radiopharmaceutical stability requirements.

Critical parameters:
• RCP drop: ≤3.0% over 8 hours
• Transchelation rate: ≤0.5 %/h
• Final RCP (8h): ≥95.0%
• Storage temperature: 2–25°C
• Light protection: Mandatory

💡 Usage tips:
1. RCP measurements must be performed by the same method (TLC/HPLC) under identical conditions.
2. Samples for transchelation analysis should be incubated at body temperature (37°C) or room temperature, specifying this in the protocol.
3. If the drug is planned to be used 6-8 hours after preparation, kinetic testing is mandatory.
4. Store prepared syringes in lead containers (which also protect from light).
5. If rapid RCP drop is detected, check the quality of the initial MAG3 lyophilizate.

⚠️ Note: Kinetic stability is the "hidden threat" of MAG3. The drug may show excellent RCP immediately after synthesis but "fall apart" after 4 hours. This utility helps identify such unstable batches before they are administered to the patient, preventing diagnostic errors due to liver accumulation.