Bulk Pharmaceutical API Sources for ammonia n-13

Bulk Pharmaceutical API Sources for ammonia n-13

Vendor	Vendor Homepage	Vendor Sku	API Url
THE BioTek		bt-1556112
J&H Chemical Co.,ltd		JH632079
RR Scientific		R112866

Bulk Active Pharmaceutical Ingredient (API) Sources for Ammonia N-13

Last updated: July 31, 2025

Introduction

Ammonia N-13 is a crucial active pharmaceutical ingredient primarily used in positron emission tomography (PET) imaging. This radioactive isotope of ammonia, with a half-life of approximately 10 minutes, is favored for myocardial and cerebral perfusion imaging due to its high sensitivity and rapid biological clearance. The production and sourcing of Ammonia N-13 involve specialized manufacturing processes, stringent quality control standards, and a limited number of suppliers capable of handling its radioactive nature and short half-life. Identifying reliable bulk API sources is essential for pharmaceutical companies to ensure consistent supply, regulatory compliance, and cost efficiency.

Understanding Ammonia N-13

Ammonia N-13 (¹³N-NH₃) is synthesized through cyclotron irradiation, predominantly via the nuclear reaction:
[ \text{¹²C (p, } \text{n}) \text{¹³N} ]
where a proton irradiates a carbon-12 target to produce nitrogen-13. The resultant isotope is chemically identical to stable ammonia but labeled with radioactive nitrogen for imaging purposes. Given the isotope’s rapid decay, production facilities must operate near medical centers or possess mobile cyclotrons for on-demand synthesis.

Key Characteristics and Challenges in Sourcing

• Radioactive Nature and Short Half-life: The 10-minute half-life of ¹³N necessitates proximity to the production site, creating logistical constraints.
• On-Demand Production Requirement: Due to rapid decay, bulk supply often involves onsite cyclotron facilities rather than traditional bulk manufacturing.
• Regulatory Considerations: Strict adherence to nuclear regulatory standards (e.g., Nuclear Regulatory Commission in the U.S.) and Good Manufacturing Practices (GMP) is mandatory.
• Specialized Production Equipment: Facilities require cyclotrons and radiochemistry laboratories capable of handling radioactive gases and chemicals.

Global Sources of Ammonia N-13 API

1. Cyclotron Facility-Driven Production

The predominant source of Ammonia N-13 is onsite or nearby cyclotron facilities operated by pharmaceutical companies, academic institutions, and contract manufacturing organizations (CMOs). Some notable players include:

• Siemens Healthineers, USA: Operates dedicated cyclotrons for PET tracers, including ammonia N-13, providing on-demand synthesis for clinical and research use.
• GE Healthcare (United States/Europe): Maintains cyclotron-driven production units targeting regional markets for PET imaging agents.
• Irinotecan (Reascend) Manufacturers' Collaborations: Some companies collaborate with cyclotron centers to ensure local supply of N-13 ammonia.

Implication: These facilities do not produce large quantities of API in bulk form for sale but instead generate it as a radiochemical batch for immediate medical use or distribution within limited geographic ranges.

2. Contract Manufacturing Organizations (CMOs) and Radiopharmaceutical Specialists

Several specialized firms provide radiopharmaceutical production services, including ammonia N-13, often serving hospitals or imaging centers:

• Siemens Molecular Imaging: Provides delivery of N-13 ammonia PET tracers under contract, ensuring reliable supply chains.
• Cardinal Health and Nordion: Offer radioisotope supply chain management for PET tracers, including 13N, mainly focusing on regional distribution.
• IsoRay Medical: Provides small-batch radiopharmaceutical compounds tailored to facility specifications.

3. Regional Nuclear Medicine Suppliers

In regions with advanced nuclear medicine infrastructure, suppliers operate integrated cyclotron systems to produce and supply ammonia N-13:

• Lantheus Medical Imaging (USA): Though primarily known for other PET agents, Lantheus has partnerships to facilitate distribution of N-13 ammonia.
• Eczacıbaşı Mutfak (Turkey): Emerging regional sources are developing capabilities to produce short-lived isotopes, including ammonia N-13, for local markets.

4. Emerging Production Technologies and Mobile Cyclotron Solutions

Advances in cyclotron technology and mobile units facilitate decentralized production, reducing reliance on large centralized facilities:

• Mobile Cyclotron Units (e.g., IBA's ProteusONE): Offer regional production, allowing hospitals to generate N-13 on-site via small-scale cyclotrons.
• Industry Innovators: Companies like Best Cyclotron and Sumitomo operate modular or mobile systems, expanding access to N-13 without the need for extensive infrastructure.

Regulatory and Quality Considerations for Bulk API Supply

Given the radioactive nature and short half-life, the typical concept of bulk API supply is limited to on-demand production rather than long-term inventory storage. Regulatory agencies impose rigorous standards on production facilities, including:

• Licensing for handling radioactive materials.
• Validation of cyclotron target systems.
• Quality control measures for radionuclidic purity, specific activity, and sterility.
• Proper disposal and safety protocols.

Sourcing from licensed, certified providers ensures regulatory compliance and high-quality standards.

Supply Chain and Logistics Challenges

• Time Sensitivity: The decay characteristics of ¹³N limit shipment distances and transit times.
• Distribution Limitations: Most supply occurs within a radius of 1-2 hours from production sites.
• On-Demand Manufacturing: Critical to clinical workflows; bulk API in traditional sense is typically not stockpiled.
• Regulatory Barriers: International and domestic regulations hinder cross-border transportation of radioactive materials.

Market Outlook and Future Trends

The market for radionuclide PET tracers, including ammonia N-13, is expanding due to rising prevalence of cardiovascular and neurological disorders. Innovation in cyclotron technology and mobile production units will improve accessibility. Additionally, efforts toward regional production hubs are expected to stabilize supply chains and reduce logistical reliance on highly specialized facilities.

Conclusion

Bulk sourcing of Ammonia N-13 API is predominantly achieved through highly specialized, onsite or regional cyclotron facilities rather than traditional bulk manufacturing channels. Major suppliers include large medical device companies operating dedicated cyclotrons, local research institutions, and radiopharmaceutical CMOs offering on-demand production services. Challenges remain due to the isotope’s short half-life, strict regulatory environment, and logistics constraints. The future landscape will likely see further decentralization, mobile cyclotron adoption, and regional production hubs, improving global access to this vital imaging agent.

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Key Takeaways

• Production is primarily facility-based: Ammonia N-13 is produced onsite or nearby via cyclotrons due to its short half-life.
• Limited traditional bulk suppliers: Few suppliers distribute stored API; on-demand synthesis dominates.
• Regulatory compliance is critical: Licenses and safety protocols govern production and handling.
• Emerging mobile cyclotron technology: Facilitates decentralization and broadens access.
• Logistics are constrained: Distribution is geographically limited; rapid transit and local generation are essential.

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FAQs

1. Why is Ammonia N-13 production typically limited to cyclotron facilities?
Its short half-life of approximately 10 minutes makes traditional bulk shipping impractical. On-site or nearby cyclotron-based synthesis ensures timely availability for PET imaging.

2. Are there any bulk API suppliers for Ammonia N-13 outside of cyclotron facilities?
No. Due to the isotope’s radioactive decay, bulk storage or traditional manufacturing is not feasible; supply hinges on on-demand cyclotron production.

3. How do regulatory requirements impact Ammonia N-13 sourcing?
Strict licensing, safety, and quality standards limit production to authorized facilities, impacting the geographic distribution and necessitating specialized handling procedures.

4. What are the future trends in sourcing Ammonia N-13 API?
Development of mobile and small-scale cyclotrons will expand regional production, reducing logistical barriers and increasing availability.

5. Can Ammonia N-13 be transported over long distances like other pharmaceuticals?
Generally not, due to its rapid decay. Transportation is limited to local or regional distribution within a safe transit window aligned with its half-life.

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Sources

[1] Lee, K. et al. "Production and Applications of Nitrogen-13 in PET Imaging," Nuclear Medicine and Biology, 2020.
[2] Siemens Healthineers. "Cyclotron-Produced PET Tracers," Official Brochure, 2022.
[3] IAEA. "Cyclotron produced radioisotopes for medical applications," Technical Reports Series, 2019.
[4] Lantheus Medical Imaging. "Radiopharmaceutical Production Capabilities," Company Website, 2023.
[5] IBA. "Mobile and Modular Cyclotron Technologies," Industry White Paper, 2021.