Ioflupane I-123 API | Radiopharmaceutical Diagnostic Agent Manufacturer in India

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Ioflupane API

Ioflupane is a cocaine analogue radiopharmaceutical ligand used in nuclear medicine for imaging the dopamine transporter (DAT) in the brain. The diagnostic agent is commonly administered as Ioflupane I-123, in which ioflupane is labeled with the radioactive isotope iodine-123.

Ioflupane I-123 SPECT imaging is used as an adjunct in the evaluation of adult patients with suspected Parkinsonian syndromes and essential tremor, helping visualize the integrity of presynaptic dopaminergic neurons.

Ioflupane API Manufacturer in India

Ioflupane is a specialized pharmaceutical compound used in the development and manufacture of radiolabeled diagnostic agents. Production requires controlled chemical synthesis, purification and, for the final radiopharmaceutical, radioiodination and radiochemical quality control.

Important quality attributes include identity, chemical purity, radiochemical purity, specific activity, radionuclidic identity, radionuclidic purity and stability.

Chemical Information

CAS Number: 83209-65-8
Molecular Formula: C19H26F2INO2
Molecular Weight: 453.32 g/mol
Drug Class: Diagnostic Radiopharmaceutical
Pharmacological Class: Dopamine Transporter Ligand
Therapeutic Class: Diagnostic Imaging Agent
Therapeutic Area: Nuclear Medicine / Neurology

Mechanism of Action

Ioflupane binds to the dopamine transporter (DAT) located on presynaptic dopaminergic nerve terminals in the striatum.

When labeled with iodine-123, the radiotracer allows visualization of striatal dopamine transporter distribution using single-photon emission computed tomography (SPECT).

Reduced DAT uptake in the striatum can support the distinction between disorders associated with loss of nigrostriatal dopaminergic neurons and conditions such as essential tremor.

Pharmaceutical Applications

Ioflupane I-123 is used as a diagnostic imaging agent for:

  • Evaluation of suspected Parkinsonian syndromes
  • Differentiation of Parkinsonian syndromes from essential tremor
  • Dopamine transporter imaging
  • Neurological nuclear medicine research

It is a diagnostic agent rather than a therapeutic drug.

Radiolabeled Ioflupane

The clinically used product contains Ioflupane labeled with iodine-123. Iodine-123 is a gamma-emitting radionuclide suitable for SPECT imaging.

The radiopharmaceutical is designed to reach the brain and bind to dopamine transporters, allowing regional DAT distribution to be assessed through gamma-camera imaging.

Manufacturing Process

Production of Ioflupane-based radiopharmaceutical material may involve:

  1. Chemical synthesis of the ioflupane precursor
  2. Purification
  3. Characterization
  4. Radioiodination with iodine-123
  5. Removal of unreacted radioactive material
  6. Radiochemical purification
  7. Sterile filtration
  8. Final formulation
  9. Radiochemical quality control
  10. Aseptic dispensing

Quality and Analytical Testing

Ioflupane / Ioflupane I-123 quality evaluation may include:

  • Chemical identity
  • Radiochemical identity
  • Chemical purity
  • Radiochemical purity
  • Radionuclidic identity
  • Radionuclidic purity
  • Specific activity
  • Residual solvents
  • Precursor-related impurities
  • Radioiodination-related impurities
  • pH
  • Sterility
  • Bacterial endotoxins
  • Filter integrity
  • Stability

Storage

Ioflupane chemical material should be stored according to its validated stability requirements. Ioflupane I-123 radiopharmaceutical requires controlled radioactive-material storage, appropriate shielding and handling according to applicable radiation-safety regulations.

Pharmaceutical Research and Development

Ioflupane is relevant to research involving:

  • Dopamine transporter imaging
  • Parkinsonian syndromes
  • Essential tremor
  • Neurodegenerative disorders
  • SPECT imaging
  • Radiopharmaceutical development
  • Nuclear medicine
  • Dopaminergic neurotransmission

Ioflupane API Summary

Ioflupane is a dopamine transporter ligand with CAS Number 83209-65-8, molecular formula C19H26F2INO2, and molecular weight 453.32 g/mol. Its iodine-123-labeled form is used as a SPECT radiopharmaceutical for visualization of dopamine transporter distribution in the brain.

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%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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