F18PSMAPETSynthesisQualityChecker

F-18 PSMA PET Synthesis Quality Checker — Quality control of F-18 PSMA synthesis

ℹ️ Utility checks critical parameters of F-18 PSMA radioligands:

• Radiochemical purity (≥95%)
• Free fluoride (≤5%)
• Precursor residue (<0.1%)
• Specific activity (≥20 GBq/umol)
• Nuclide identification by T1/2

⚠️ CRITICAL: Free fluoride accumulates in bones, mimicking metastases!

F-18 PSMA is used for prostate cancer staging.

High specific activity is necessary for sensitivity to small lesions.

Usage

F18PSMAPETSynthesisQualityChecker.exe → demo mode (console output)

F18PSMAPETSynthesisQualityChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,FreeFluoridePercent,PrecursorPercent,SpecificActivityGBq_per_umol,pH,ResidualSolventsPPM,EndotoxinsEU_per_mL,SterilityTest,ActivityMBq,RadionuclidicPurityPercent,F18HalfLifeMin

Example

F18-PSMA-2026-001,99.0,0.5,0.1,50.0,7.0,100.0,10.0,0,2000.0,99.99,109.8

— WHY IS THIS NEEDED?

F-18 PSMA (e.g., PSMA-1007, DCFPyL) is gold standard for PET diagnosis of prostate cancer.

• Binds to prostate-specific membrane antigen (PSMA).
• F-18 has ~110 minute half-life, convenient for logistics.
• Requires high radiochemical purity to avoid artifacts.
• Free fluoride (F-18) is actively taken up by bone tissue, which can lead to false-positive metastasis diagnosis.

⚠️ CRITICAL:

• Radiochemical purity ≥95% — guarantee of specific binding to PSMA.
• Free fluoride ≤5% — minimization of background accumulation in skeleton.
• Precursor residue <0.1% — toxicity control of unreacted substance.
• Specific activity ≥20 GBq/umol — necessary for high image contrast.
• Nuclide identification by half-life (105-115 min) is mandatory.
• Residual solvents (acetonitrile) must be minimal (<500 ppm).
• pH 6.0-8.0 — for biocompatibility.
• Endotoxins <175 EU/mL — standard for parenteral drugs.
• Sterility — MANDATORY.

Key features

• Strict control of free fluoride, critical for bone diagnostics.
• Assessment of residual precursor after module synthesis.
• Specific activity check for effective targeting.
• Nuclide identification by decay kinetics.
• Compliance with GMP and Pharmacopoeia requirements for F-18 radiopharmaceuticals.

Critical parameters

• Radiochemical purity: ≥95.0%
• Free fluoride: ≤5.0%
• Precursor residue: <0.1%
• Specific activity: ≥20.0 GBq/umol
• Radionuclidic purity: ≥99.9%
• Half-life: 105–115 min
• Residual solvents: <500 ppm
• pH: 6.0–8.0
• Endotoxins: <175 EU/mL
• Sterility: no growth

💡 Usage tips:

1. Radiochemical purity and free fluoride determined by TLC or HPLC.

2. Half-life measured over 20-30 minutes to confirm presence of F-18.

3. Synthesis usually performed on automatic modules (GE TracerLab, Siemens Explora, etc.).

4. High specific activity achieved using carrier-free F-18 fluoride.

5. Drug must be used within few hours after synthesis due to decay.

⚠️ Note: F-18 PSMA is replacing Ga-68 PSMA due to better physical properties of F-18 (lower positron energy, higher resolution) and logistics convenience. However, fluorine chemistry requires careful control of purification from free fluoride, as even small impurities can significantly distort disease picture.