Cu64ATSMQualityChecker

Cu-64 ATSM Quality Checker — Quality control of Cu-64 ATSM hypoxia tracer

ℹ️ Utility checks critical parameters of Cu-64 ATSM:

• Radiochemical purity (≥95%)
• Free copper (≤5%)
• Specific activity (≥10 GBq/umol)
• Co-60 impurity (<0.001%) — CRITICAL!
• Residual solvents, pH, endotoxins, sterility

⚠️ CRITICAL: Free copper accumulates in liver, masking hypoxia!

Cu-64 ATSM crosses BBB, requiring high drug purity.

Co-60 impurity is formed during Ni-64 target irradiation and must be minimal.

Usage

Cu64ATSMQualityChecker.exe → demo mode (console output)

Cu64ATSMQualityChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,FreeCopperPercent,SpecificActivityGBq_per_umol,pH,ResidualSolventsPPM,EndotoxinsEU_per_mL,SterilityTest,ActivityMBq,RadionuclidicPurityPercent,Co60ImpurityPercent

Example

CU64-ATSM-2026-001,98.0,1.5,15.0,7.0,200.0,15.0,0,500.0,99.95,0.0005

— WHY IS THIS NEEDED?

Cu-64 ATSM (Diacetyl-bis(N4-methylthiosemicarbazone)copper) is a unique tracer for hypoxia imaging.

• Crosses blood-brain barrier (BBB), allowing brain hypoxia study.
• Retained in cells with low partial oxygen pressure.
• Cu-64 has 12.7-hour half-life, convenient for logistics.
• Produced on cyclotron via Ni-64(p,n)Cu-64 reaction.

⚠️ CRITICAL:

• Radiochemical purity ≥95% — guarantee of specific accumulation in hypoxic tissues.
• Free copper ≤5% — free Cu ions accumulate in liver and kidneys, creating high background.
• Specific activity ≥10 GBq/umol — necessary for effective binding without receptor saturation.
• Co-60 impurity <0.001% — Co-60 is byproduct of reaction and has long half-life (5.27 years), creating unnecessary radiation burden.
• Residual solvents (ethanol, DMSO) 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 Co-60 impurity characteristic of cyclotron production.
• Assessment of free copper content, critical for image quality.
• Specific activity check for effective hypoxia targeting.
• Compliance with GMP requirements for PET radiopharmaceuticals.
• Comprehensive safety check (endotoxins, sterility, pH, solvents).

Critical parameters

• Radiochemical purity: ≥95.0%
• Free copper: ≤5.0%
• Specific activity: ≥10.0 GBq/umol
• Radionuclidic purity: ≥99.9%
• Co-60 impurity: <0.001%
• Residual solvents: <500 ppm
• pH: 6.0–8.0
• Endotoxins: <175 EU/mL
• Sterility: no growth

💡 Usage tips:

1. Radiochemical purity determined by TLC or HPLC.

2. Co-60 impurity controlled by gamma spectrometry.

3. Due to 12.7-hour half-life, drug can be transported to neighboring regions.

4. ATSM chelator must be high purity to avoid side complex formation.

5. Protection from positron radiation (511 keV) is required when working with Cu-64.

⚠️ Note: Cu-64 ATSM is one of few tracers capable of quantitatively assessing brain hypoxia. This makes it indispensable tool in oncology and neurology, but requires highest level of quality control due to complexity of copper chemistry.