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
BenchChem		B1218466
THE BioTek		bt-1554287
J&H Chemical Co.,ltd		JH738254
RR Scientific		R335926

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

Last updated: July 31, 2025

Introduction

Indium, a critical trace element with diverse applications ranging from electronics to medical imaging, plays an integral role as a component in the pharmaceutical industry, particularly in the form of isotopes like Indium-111. The isotope Indium-111 is extensively utilized in nuclear medicine for diagnostic imaging, including radiolabeling of monoclonal antibodies, peptides, and other vectors. To facilitate these applications, the procurement of high-purity Indium-based APIs, notably in compound form such as Indium-111 oxyquinoline, is vital. This article provides a comprehensive overview of current sources, manufacturing considerations, and strategic insights into sourcing Indium-111 oxyquinoline APIs for pharmaceutical applications.

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Understanding Indium-111 Oxyquinoline

Indium-111 oxyquinoline, also termed In-111 oxine or In-111 labeled oxine, arises from the chelation of Indium-111 with oxyquinoline (also known as 8-hydroxyquinoline). Chemically, this creates a lipophilic complex that efficiently penetrates cellular membranes, making it an effective radiopharmaceutical for cellular and molecular imaging.

The synthesis of this API involves complexation processes under strict sterile, Good Manufacturing Practice (GMP) conditions, often requiring intermediates derived from high-purity Indium-111 sources. The stability, bioavailability, and radiochemical purity of Indium-111 oxyquinoline depend explicitly on the quality of the raw Indium-111 used.

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Sources of Bulk Indium for API Production

1. Commercial Suppliers of Indium-111

The supply chain for Indium-111 primarily comprises isotope producers specializing in nuclear medicine radioisotopes. Major players include:

• Nordion (Canadian Nuclear Laboratories)

  Nordion is a historic leader in radioisotope supply, including Indium-111. They provide high-purity, cyclotron-produced Indium-111, suitable for medical formulations.

• PerkinElmer

  A notable player offering a range of radiopharmaceutical-grade isotopes, including Indium-111. Their isotopes are characterized by high radiochemical purity and compliance with international quality standards.

• ITM Isotopen Technologien München (ITM)

  ITM supplies cyclotron-produced Indium-111 with radiochemical purity suitable for pharmaceutical applications. They emphasize traceability and regulatory compliance.

• Mallinckrodt Pharmaceuticals

  Although better known for other isotopes, Mallinckrodt sources and supplies Indium-111 for research and clinical use, adhering to GMP standards.

2. Local and Regional Suppliers

Regional nuclear medicine facilities and isotope generators can sometimes produce Indium-111 in-house or through regional distributors, mainly in countries with advanced nuclear medicine infrastructures (e.g., Germany, the UK, Japan). For large-scale pharmaceutical API manufacturing, sourcing from international suppliers remains the preferred route due to standardization requirements.

3. Custom Synthesis and Contract Manufacturing

Some companies offer custom synthesis of Indium-111 complexes, including oxyquinoline derivatives, leveraging high-purity Indium-111 supplied from established suppliers. Contract Manufacturing Organizations (CMOs) specialized in radiopharmaceuticals provide end-to-end solutions, including purification, complexation, and formulation.

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Criteria for Selecting Indium-111 Source

• Radiochemical Purity: Must meet pharmacopeial standards (typically ≥ 99%) for medical use.
• Traceability & Certification: GMP compliance, Lot-specific quality assurance, and detailed certificates of analysis (CoA).
• Supply Chain Reliability: On-time delivery and flexibility in quantity adjustments.
• Regulatory Compliance: Approval for distribution in the intended markets, with adherence to ICH and FDA/EMA guidelines.
• Cost Considerations: Balancing quality standards with economic feasibility, especially for high-volume manufacturing.

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Manufacturing and Quality Control

The synthesis of Indium-111 oxyquinoline requires stringent control measures:

• Radionuclide Handling: Performed in shielded facilities with state-of-the-art radiation safety protocols.
• Purification Techniques: Ion-exchange chromatography, solvent extraction, or other methods to achieve desired radiochemical purity.
• Quality Testing: Radiochemical purity, sterility, pyrogen testing, and specific activity determination conforming to pharmacopeial standards (e.g., USP, EP).

Manufacturers often collaborate with isotope producers for raw material supply and rely on validated processes for complexation and final product formulation.

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Emerging Trends & Strategic Insights

• Isotope Production Enhancements: Advances in cyclotron technology and targetry have improved yield, purity, and consistency of Indium-111 supplies.
• Automation & GMP-Grade Production: Increasing automation in synthesis reduces contamination risk and improves reproducibility.
• Regulatory Harmonization: Efforts by the IAEA and other agencies aim to standardize specifications and improve global supply chain security.
• Alternative Sources & Suppliers: Emerging producers in Asia and Eastern Europe are expanding their capacity to meet global demand.

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Conclusion

Securing a reliable, high-quality bulk API source for Indium-111 oxyquinoline hinges on establishing relationships with reputable isotope suppliers or CMOs that adhere to the highest standards of purity, safety, and regulatory compliance. With growing demand from nuclear medicine and personalized diagnostics, supply chain resilience and quality assurance are paramount. Strategic partnerships and continuous quality monitoring ensure consistent, effective radiopharmaceutical production.

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Key Takeaways

• The primary sources of bulk Indium-111 for pharmaceutical applications include Nordion, PerkinElmer, and ITM, all offering GMP-grade isotopes.
• Selection criteria should emphasize purity, traceability, regulatory approval, and supply reliability.
• Manufacturing of Indium-111 oxyquinoline involves complex radiochemical procedures demanding specialized facilities.
• Increasing innovation in isotope production and automation enhances supply stability and product consistency.
• Establishing robust supplier relationships and adhering to quality standards safeguard the integrity of the final API.

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FAQs

1. What are the main considerations when sourcing Indium-111 for pharmaceutical use?
Purity, regulatory compliance, supply reliability, and traceability are critical. Suppliers must provide GMP-grade isotopes with certificates of analysis confirming the required specifications.

2. How does Indium-111 quality impact the efficacy of oxyquinoline complexes?
High radiochemical purity ensures optimal labeling efficiency, stability, and safety of the radiopharmaceutical, directly affecting imaging accuracy and patient safety.

3. Are regional suppliers viable for large-scale API production?
While regional suppliers can serve localized needs, global suppliers with established GMP certifications and regulatory approvals are preferred for large-scale pharmaceutical manufacturing.

4. Can Indium-111 be produced in-house?
Some facilities with cyclotrons or nuclear reactors may produce Indium-111 in-house, but this requires substantial infrastructure, regulatory clearance, and expertise to ensure product quality.

5. What future developments could influence the source landscape for Indium-111 APIs?
Advances in accelerator technology, new regional production facilities, and international standardization efforts are likely to improve availability and reduce costs.

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References

1. [1] International Atomic Energy Agency (IAEA). "Production and Quality Control of Radiopharmaceuticals." IAEA Radioisotopes Series.
2. [2] Nordion. "Indium-111 for Diagnostic Imaging." Product Data Sheet.
3. [3] PerkinElmer. "Radioisotope Solutions for Nuclear Medicine." Brochure.
4. [4] ITM Isotopen Technologien München. "GMP Grade Indium-111." Technical Specification Sheet.
5. [5] European Pharmacopoeia. "Radiopharmaceuticals Standards." EIFSS, 2020.