Bulk Pharmaceutical API Sources for XENON XE 133-V.S.S.

Bulk Pharmaceutical API Sources for XENON XE 133-V.S.S.

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1212064
THE BioTek		bt-1549503
J&H Chemical Co.,ltd		JH152051
RR Scientific		R117997

Bulk Active Pharmaceutical Ingredient (API) Sources for: XENON XE 133-V.S.S.

Last updated: July 30, 2025

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Introduction

XENON XE 133-V.S.S. is a specialized pharmaceutical product that contains the radioactive isotope Xenon-133. This isotope's unique properties make it indispensable in medical imaging, notably in lung ventilation scans and other nuclear medicine procedures. As demand grows globally for high-quality radioactive APIs, understanding the landscape of bulk API sources for Xenon-133 is essential for pharmaceutical companies, radiopharmacies, and healthcare providers.

Given its radiochemical complexity and regulatory considerations, sourcing Xenon-133 involves navigating a specialized supply chain. This article elucidates the primary sources, manufacturing processes, quality criteria, and strategic considerations vital to procurement.

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Overview of Xenon-133 API Production

Xenon-133, a radioisotope with a short half-life of approximately 5.25 days, is produced mainly via nuclear reactors through neutron activation of isotopes of tellurium. Its radiochemical purity and radiopurity are critical parameters to ensure efficacy and safety in medicinal applications.

Production Methodologies

• Neutron activation of Tellurium-132: The primary route involves irradiating tellurium-132 targets in nuclear reactors, inducing a (n,γ) reaction that produces Xenon-133.
• Extraction and Purification: Post-irradiation, the Xenon-133 gas is separated from target materials via cold traps, chromatography, and cryogenic distillation, ensuring removal of impurities and other radionuclides.

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Key Global Producers of Xenon-133 API

1. National Nuclear Reactors and Government Agencies

Major sources are typically government-operated reactor facilities capable of producing radioisotopes. These facilities often supply to licensed commercial radiopharmacies under strict regulatory oversight.

• United States:
  The Oak Ridge National Laboratory (ORNL) historically produced Xenon-133, primarily for academic and research purposes. However, commercial supply is now predominantly handled by licensed vendors.

• France:
  Institut de Radioprotection et de Sûreté Nucléaire (IRSN) and CEA Saclay operate reactors capable of isotope production. France's supply chain is robust, with dedicated radiopharmaceutical production centers.

• Russia:
  The Research Institute of Atomic Reactors (RIAR) and State Nuclear Energy Corporation (ROSATOM) manage substantial isotope production modules, exporting Xenon-133 to international markets.

• Japan:
  The Japan Atomic Energy Agency (JAEA) provides Xenon-133 via reactor facilities, focusing on both medical applications and research.

2. Commercial Radiopharmaceutical Suppliers

Several private and semi-private companies have established stable supply chains for radioactive APIs, including Xenon-133, often integrating production with licensing and distribution expertise.

• GE Healthcare / Covidien:
  Historically involved in radiopharmaceutical solutions, these corporations have sourced Xenon-133 from licensed reactors and supplied to hospitals and imaging centers.

• Bracco Imaging:
  An Italian company that has invested in Xenon-133 production, emphasizing high radiopurity and regulatory compliance.

• Nordion (Canada):
  Nordion specializes in medical isotopes, including Xenon-133, sourcing from reactors with stringent quality controls.

• Izon Science (New Zealand):
  Focuses on specialty radioisotopes, including Xenon-133, with an emphasis on purity and reliable supply.

3. Private Industrial Producers

Emerging companies and regional suppliers are entering the market, often partnering with reactor facilities or establishing small-scale reactor modules.

• International Isotope Suppliers:
  Several companies in Europe and Asia import reactor-produced Xenon-133 and repackage or distribute it following regulatory standards.

• Emerging Small-Scale Reactor Installations:
  Novel reactor designs (e.g., accelerator-driven systems) aim to provide localized isotope production, potentially reducing lead times and logistical complexities.

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Supply Chain Challenges and considerations

Regulatory Compliance and Certification

Xenon-133 as a radiopharmaceutical API must adhere to strict regulatory frameworks, including Good Manufacturing Practice (GMP), from agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and counterparts worldwide.

Procurement must verify:

• Source licensing and compliance
• Radiopurity and sterility certifications
• Stability and half-life considerations for logistics

Availability and Lead Time

Due to its short half-life, timely procurement is critical. Many sources operate on a just-in-time basis, with production tied directly to demand cycles. Supply inconsistencies can arise from reactor maintenance, regulatory delays, or geopolitical factors.

Quality and Purity Standards

Crucial parameters include:

• Radiochemical purity: Minimum 99%
• Chemical purity: Absence of tellurium or other impurities
• Sterility & Endotoxin levels: Especially for injection-grade APIs

Selecting sources capable of meeting these criteria minimizes clinical and regulatory risks.

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Emerging Trends and Future Outlook

• Alternative Production Technologies:
  Innovations such as accelerator-based isotope production are gaining attention, potentially decentralizing supply chains and reducing reliance on aging reactors.

• Regional Production Hubs:
  To mitigate logistical challenges, regional manufacturing centers aligned with local demand are being developed, promising more reliable and cost-effective supply.

• Regulatory Harmonization:
  Increasing international collaboration aims to harmonize standards, simplifying cross-border procurement.

• Supply Security Initiatives:
  Governments and industry consortia are investing in backup production capabilities and stockpiles to prevent shortages.

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Strategic Considerations for Buyers

• Establish partnerships with multiple certified suppliers to diversify risk.
• Prioritize suppliers with proven adherence to GMP and ISO standards.
• Maintain close communication with production timelines, especially given the radiation's half-life.
• Evaluate the supplier’s handling and delivery capabilities, including logistics and stability measures.
• Monitor regulatory updates affecting import/export and licensing requirements.

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Conclusion

Securing a reliable source of Xenon-133 API demands a comprehensive understanding of the global production landscape. The primary sources are healthcare-focused nuclear reactors, operated mainly by government agencies and specialized commercial entities. As the radioactive API’s short half-life complicates logistics, establishing robust, compliant, and diversified supply chains is essential for healthcare providers and pharmaceutical entities invested in nuclear medicine.

Emerging technological advancements and regionalized production initiatives promise enhanced supply stability and reduced costs. Nevertheless, ongoing regulatory vigilance and quality assurance remain the cornerstones for successful procurement and use of Xenon-133.

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Key Takeaways

• Xenon-133 API sourcing hinges on nuclear reactor-based production, primarily from government-run facilities in the US, France, Russia, and Japan.
• Commercial suppliers, including Nordion and Izon Science, serve global markets with certified, high-purity Xenon-133.
• Supply chain reliability is challenged by the isotope’s short half-life, requiring tight logistical coordination.
• Emerging accelerator-based methods and regional centers aim to enhance supply security.
• Rigorous regulatory compliance, quality assurance, and supplier diversification are critical for dependable procurement.

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FAQs

1. What are the primary sources for bulk Xenon-133 API?
Major sources include nuclear reactor facilities operated by government agencies such as ORNL (US), CEA (France), RIAR (Russia), and JAEA (Japan). Commercial suppliers like Nordion and Izon Science also provide certified Xenon-133.

2. How does the short half-life of Xenon-133 affect supply logistics?
Its ~5.25-day half-life necessitates rapid transportation and tight logistical coordination to ensure the API remains effective at the point of use, often requiring close proximity between production sites and end-users.

3. What quality standards are essential for Xenon-133 API?
High radiochemical purity (>99%), chemical purity, sterility, and endotoxin-free status are mandatory, conforming to GMP and other regulatory standards.

4. Are there alternative methods for producing Xenon-133?
Yes, advances in accelerator-driven isotope production aim to decentralize and diversify supply sources, reducing dependence on aging nuclear reactors.

5. How can buyers mitigate supply risks associated with Xenon-133?
By establishing relationships with multiple licensed suppliers, maintaining inventory buffers, and ensuring strict quality assessments aligned with regulatory standards.

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References
[1] International Atomic Energy Agency (IAEA). “Radioisotope Production Technologies” (2020).
[2] Nordion. “Radioisotope Supply Chain Overview” (2022).
[3] European Pharmacopoeia. “Guidelines for Radiopharmaceuticals” (2021).
[4] US FDA. “Guidance for Industry: Radioactive Drugs” (2019).
[5] Izon Science. “Xenon-133 Product Specifications and Production Methods” (2023).