Flutemetamol F 18 API / Radiopharmaceutical in India

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Flutemetamol

Flutemetamol is a benzothiazole-derived amyloid imaging ligand used in its radioactive fluorine-18 labeled form, flutemetamol F 18, as a positron emission tomography (PET) diagnostic agent. The non-radioactive flutemetamol has the molecular formula C₁₄H₁₁FN₂OS, CAS 637003-10-2, and molecular weight 274.32 g/mol.

The clinically used radiopharmaceutical is [¹⁸F]flutemetamol, in which stable fluorine is replaced by radioactive fluorine-18. It is used for PET imaging to estimate β-amyloid neuritic plaque density in the brain.

Key Features

  • Product Name: Flutemetamol
  • Radiopharmaceutical Name: Flutemetamol F 18
  • Non-radioactive CAS: 637003-10-2
  • Flutemetamol F 18 CAS: 765922-62-1
  • Non-radioactive Molecular Formula: C₁₄H₁₁FN₂OS
  • F 18 Molecular Formula: C₁₄H₁₁[¹⁸F]N₂OS
  • Non-radioactive Molecular Weight: 274.32 g/mol
  • F 18 Molecular Weight: 273.32 g/mol
  • Chemical Class: Benzothiazole derivative
  • Pharmacological/Diagnostic Class: Amyloid PET imaging agent
  • Route: Intravenous
  • Radiopharmaceutical: Yes, when labeled with ¹⁸F
  • PET Imaging Agent: Yes

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 6.0–8.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Melting Point 168°C – 172°C
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