Bulk Pharmaceutical API Sources for INDIUM IN-111 OXYQUINOLINE

Bulk Pharmaceutical API Sources for INDIUM IN-111 OXYQUINOLINE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		119117
NovoSeek		3034762
Kingston Chemistry		KST-1A7440
AAA Chemistry		AR-1A0375
ABI Chem		AC1L3O8K
ABI Chem		AC1MHY67

Bulk Active Pharmaceutical Ingredient (API) Sources for Indium-111 Oxyquinoline

Last updated: August 2, 2025

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Introduction

Indium-111 oxyquinoline, a radiopharmaceutical agent primarily used in diagnostic imaging, particularly for tumor and infection localization, comprises the radioactive isotope indium-111 conjugated to the chelating agent oxyquinoline. As a complex, its production depends on sourcing high-purity indium-111, a key component in the formulation, which must meet stringent pharmaceutical standards. Understanding the global landscape of bulk API sources for indium-111 oxyquinoline is crucial for pharmaceutical manufacturers, radiopharmacies, and researchers aiming to ensure supply chain integrity, regulatory compliance, and cost efficiency.

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Understanding Indium-111 and Its Role in Medical Imaging

Indium-111 (^111In) is a gamma-emitting radioisotope with a half-life of approximately 2.8 days, making it suitable for diagnostic imaging within a practical timeframe. It is commonly produced through nuclear reactor irradiation of enriched zinc-111 or tin targets, or via cyclotron for specific isotopic variants. Its incorporation into oxyquinoline forms a complex capable of targeting certain biological markers for scintigraphy.

The production of ^111In for medical applications requires access to high-purity materials and sophisticated separation processes, often tapping into specialized nuclear chemistry facilities. Its integration into radiopharmaceuticals like indium-111 oxyquinoline demands strict adherence to Good Manufacturing Practices (GMP), radiochemical purity, and specific activity thresholds.

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Primary Sources of Indium-111 API

1. Nuclear Reactor Facilities

The predominant method to obtain ^111In involves neutron irradiation of zinc-112 or tin targets within nuclear reactors. Countries with advanced nuclear infrastructure include:

• United States:

  The US possesses several high-flux research reactors capable of producing ^111In, such as those operated by the National Laboratories (e.g., Oak Ridge National Laboratory). Commercial producers, often affiliated with research reactors, supply bulk ^111In to pharmaceutical companies.

• Europe:

  France (CEA Marcoule), Belgium, and the UK maintain reactors capable of ^111In production. European facilities often collaborate with pharmaceutical companies, supplying high-quality ^111In for radiopharmaceutical synthesis.

• Asia:

  Japan’s Japan Atomic Energy Agency (JAEA) operates reactors generating ^111In, catering to domestic and regional demands.

Key Point: These reactor-produced ^111In sources usually supply the material as a chloride or citrate solution, designated for pharmaceutical formulation after appropriate radiochemical processing.

2. Commercial Radiopharmaceutical Suppliers

Several companies specialize in producing and distributing bulk ^111In API for radiopharmaceutical manufacturing:

• Isotope suppliers (e.g., ITM Isotopen Technologien München AG, Nordion [later acquired by Sterigenics]) produce ^111In solutions, often pre-qualified under international pharmacopoeias such as USP, EP, and Ph. Eur.

• Custom synthesis providers such as Bracco Imaging, Curium, and Eckert & Ziegler can supply bulk ^111In, often tailored to client specifications for clinical or research purposes.

These suppliers typically obtain reactor-produced ^111In in compliance with radiation safety and quality standards, and their products are validated for pharmaceutical use.

3. Direct Nuclear Production and Outsourced Processing

Some pharmaceutical companies or research institutions with nuclear chemistry capabilities produce ^111In in-house, particularly in countries with robust nuclear infrastructures (e.g., Australia, Canada). They handle the irradiation, separation, purification, and QC processes internally, enabling a secure, customized supply chain.

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Regulatory and Quality Considerations

API sources for radiopharmaceuticals like indium-111 oxyquinoline must adhere to strict regulatory frameworks:

• GMP Compliance: Ensures batch-to-batch consistency, purity, and safety.
• Radionuclidic Purity: Critical for minimizing patient radiation dose and optimizing imaging quality.
• Radiochemical Purity: High purity of the indium-111 radioisotope in the desired chemical form.
• Traceability and Documentation: Complete documentation for audit trails, including source reactor details, purification processes, and QC testing.

Major suppliers providing validated, GMP-grade ^111In are well-positioned to support pharmaceutical companies in meeting these standards.

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Emerging Trends and Alternative Sources

While reactor-based production remains the standard, advances in cyclotron technology and accelerator-driven isotope production may influence future supply landscapes. Alternate routes, such as the accelerator-based generation of ^111In via proton bombardment of target materials, are under research but are not yet commercially widespread.

Additionally, the development of generator systems—analogous to technetium-99m generators—remains limited for ^111In, primarily due to its production complexity and half-life.

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Supply Chain Challenges

• Limited Production Capacities: Reactor availability and scheduling constraints can lead to supply shortages.
• Logistical Complexities: Handling and distribution of radioactive material require specialized transport protocols.
• Regulatory Variability: Differing global standards may complicate import/export for cross-border supply.

Efficient sourcing necessitates establishing relationships with established, compliant suppliers capable of consistent delivery.

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Conclusion

The procurement of bulk indium-111 for oxyquinoline complexation hinges on reliable reactor-based production and partnerships with GMP-compliant radiochemical suppliers. The primary sources include research reactors at national labs, commercial isotope producers, and specialized radiopharmaceutical firms across North America, Europe, and Asia. Sponsoring entities must prioritize quality assurance, regulatory compliance, and logistical coordination to maintain uninterrupted supply chains for this critical diagnostic agent.

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Key Takeaways

• Primary ^111In sources are reactor-produced, requiring high-purity and GMP standards for medical use.
• Major suppliers include government-operated research reactors and commercial radiopharmaceutical companies.
• Regulatory compliance and traceability are paramount, necessitating partnerships with validated suppliers.
• Emerging production methods, such as cyclotron or accelerator-driven techniques, may diversify future supply options.
• Supply chain complexity underscores the importance of early procurement planning and supplier relationship management.

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FAQs

Q1: What is the typical half-life of indium-111 used in medical imaging?
A: Approximately 2.8 days (67.8 hours), suitable for imaging over several days post-administration.

Q2: Are there international standards governing the quality of ^111In APIs?
A: Yes, standards are outlined in pharmacopeias such as USP, EP, and Ph. Eur., emphasizing radionuclidic and radiochemical purity, sterility, and apyrogenicity.

Q3: Can non-reactor sources supply ^111In for radiopharmaceuticals?
A: Currently, reactor-based production remains dominant; alternative methods like cyclotron or accelerator-driven generation are under development but not yet commercially widespread.

Q4: How do supply chain disruptions impact the production of indium-111 oxyquinoline?
A: Disruptions can lead to delays in diagnostics, increased costs, and potential shortages, emphasizing the need for diversified sourcing strategies.

Q5: What regulatory considerations must be addressed when sourcing ^111In API for clinical use?
A: Ensuring GMP compliance, proper documentation, safety protocols during transportation, and validation of the API in line with local health authorities.

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Sources:

[1] International Atomic Energy Agency. “Production of Radionuclides for Medical Applications,” IAEA-TECDOC-1569, 2008.
[2] European Pharmacopoeia. Radionuclide derivatives and quality standards.
[3] NRC and WHO Guidelines on the Production and Quality Control of Radioisotopes.
[4] International Society of Radionuclide Molecular Therapy. Production and Handling of Medical Radioisotopes.
[5] Nuclear Chemistry & Isotope Supply, specialized supplier profiles, 2022.