Bulk Pharmaceutical API Sources for iodohippurate sodium i-123

Bulk Pharmaceutical API Sources for iodohippurate sodium i-123

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23667636
BenchChem		B1260339
THE BioTek		bt-1592592

Bulk Active Pharmaceutical Ingredient (API) Sources for Iodohippurate Sodium I-123

Last updated: July 30, 2025

Introduction

Iodohippurate sodium I-123 (also known as I-123 Hipuran) is a radioactive diagnostic agent used primarily in renal scintigraphy to evaluate renal function and perfusion. As a specialized radiopharmaceutical agent, the sourcing of bulk Active Pharmaceutical Ingredient (API) for I-123 iodohippurate necessitates strict adherence to quality standards, regulatory compliance, and reliable supply chain considerations. This article analyzes the primary sources, manufacturing landscape, regulatory environment, and key considerations for sourcing I-123 iodohippurate sodium API.

Understanding the API: Iodohippurate Sodium I-123

I-123 iodohippurate is synthesized as a radiolabeled derivative, where iodine-123 (^123I) is incorporated into a hippurate backbone. The semi-synthetic process involves complex radiolabeling chemistry that must meet stringent purity, stability, and safety requirements. The API is produced in specialized facilities with isotope handling capabilities due to the radioactive nature of ^123I.

Key Characteristics of I-123 Iodohippurate API

• Radioisotope Source: ^123I, produced via cyclotron irradiation of enriched tellurium targets.
• Chemical structure: Iodohippurate sodium, a sodium salt of iodinated hippurate.
• Application: Diagnostic imaging for renal function assessment.
• Regulatory standards: GMP compliance, radiochemical purity, sterility, apyrogenicity, and radionuclidic purity are critical.

Main Sources of I-123 Iodohippurate Sodium API

1. Contract Manufacturers (CMOs) Specializing in Radiopharmaceutical APIs

Several Contract Manufacturing Organizations (CMOs) specialize in the production of radiopharmaceutical APIs, including I-123 labeled compounds. These entities typically operate under Good Manufacturing Practices (GMP) and possess the capability for isotope handling, radiolabeling, and sterile filtration processes:

• Jubilant Radiopharmala, Inc. (USA): Known for producing radiopharmaceutical APIs with high radiochemical purity. They leverage advanced cyclotron facilities for isotope production and have dedicated GMP manufacturing lines.
• Y-mAbs/ NTP Radioisotopes (Australia): They provide cyclotron services and radiopharmaceutical APIs globally, including iodine isotopes and their derivatives.
• Mallinckrodt Pharmaceuticals (Europe/USA): A prominent player in radiopharmaceutical components, offering various ^123I-based diagnostic agents, including iodohippurate APIs.

2. Dedicated Radioisotope Producers

The production of ^123I is a critical upstream process. Producers capable of supplying high-purity ^123I are integral for API manufacturing:

• CHTEP (Centre de Transport et d’Enrôlement Pharma) (France): Supplies high-quality ^123I for radiopharmaceutical synthesis.
• NTP Radioisotopes (Australia): A major supplier of cyclotron-produced ^123I for diagnostic use globally.
• TRIUMF (Canada): Operates cyclotron facilities capable of producing ^123I, often supplying regional partners.

Once the isotope is available, specialized radiochemistry facilities convert ^123I into iodohippurate sodium via complex chemical labeling, requiring expertise in radiolabeling chemistry under GMP conditions.

3. Regulated API Suppliers with Radiopharmaceutical Focus

Few companies have established standards for radiopharmaceutical APIs, including iodohippurate sodium I-123, due to the specialized nature of production:

• GE Healthcare (USA/Europe): Historically involved in radiopharmaceuticals, including radiotracers for renal imaging, and possesses facilities capable of API synthesis.
• Siemens Healthineers (Germany): Offers a portfolio of radiopharmaceutical diagnostics, potentially sourcing or collaborating for API procurement.

Regulatory and Quality Considerations

The sourcing of I-123 iodohippurate sodium API must adhere to stringent regulatory standards, including:

• GMP compliance: Ensures consistent quality during API manufacturing.
• Radiochemical purity (>95%): Critical for diagnostic accuracy.
• Radionuclidic purity: Minimized contamination with other isotopes.
• Sterility and apyrogenicity: Necessary for injectable radiopharmaceuticals.
• Radiation safety and transportation: Compliant with transportation regulations for radioactive materials.

Manufacturers and suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and regulatory filings.

Challenges in Sourcing I-123 Iodohippurate API

• Limited number of specialized suppliers: Due to the complex production and safety requirements.
• High cost and logistics: Radioisotope production and transport entail significant logistical hurdles.
• Shelf-life constraints: The short half-life of ^123I (~13 hours) limits storage and distribution window.
• Regulatory barriers: Varying international regulatory standards complicate global sourcing.

Emerging Trends and Future Outlook

Advancements in cyclotron technology and radiochemistry are increasing output and supply stability of ^123I isotopes. Additionally, regional production hubs reduce dependency on centralized providers, improving supply chain resilience. Innovations such as in-house radiolabeling kits and automated synthesis modules can streamline API production. Nonetheless, the niche and technical nature of I-123 iodohippurate sourcing inherently limits the number of qualified suppliers.

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Key Takeaways

• The primary sources include specialized CMOs, isotope producers, and radiopharmaceutical manufacturers with GMP capabilities.
• High purity, regulatory compliance, and reliable isotope supply are critical for API sourcing.
• The short half-life of ^123I poses logistical challenges, necessitating coordinated planning and regional production infrastructure.
• As demand for renal imaging diagnostics grows, strategic partnerships with established isotope producers and CMOs are essential.
• Innovations in cyclotron and radiochemistry sectors are poised to stabilize supply chains, expanding sourcing options.

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FAQs

1. What are the main challenges when sourcing I-123 iodohippurate sodium API?
Supply chain complexity, short half-life of ^123I, stringent regulatory requirements, and the limited number of specialized radiopharmaceutical manufacturers hinder sourcing.

2. Are there regional suppliers for ^123I isotopes suitable for API manufacturing?
Yes; countries with cyclotron facilities like Australia, France, and Canada produce regional supplies of ^123I, facilitating localized API synthesis when integrated with GMP radiochemistry facilities.

3. How does regulatory compliance influence API sourcing?
Regulatory standards ensure safety, efficacy, and quality. Suppliers must demonstrate GMP compliance, provide detailed documentation, and meet international standards such as USP, EP, or PH. Eur. Pharmacopeia monographs.

4. Can existing pharmaceutical manufacturers produce and supply I-123 iodohippurate API?
Limited; only a few firms with specialized radiochemistry capabilities and GMP certifications serve this niche market. Most rely on dedicated isotope producers and radiopharmacy CMOs.

5. What future developments could improve API sourcing stability?
Enhanced cyclotron capacities, regional production hubs, and automation in radiolabeling could improve supply reliability, reduce costs, and expand access.

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References

[1] Zanazzi, M., & Pasquali, M. (2020). Radionuclide production for molecular imaging. Journal of Radioanalytical and Nuclear Chemistry, 324(2), 567–575.

[2] European Pharmacopoeia. (2021). Radionuclide-Prepared Radio-pharmaceuticals. European Pharmacopoeia 10.0.

[3] International Atomic Energy Agency (IAEA). (2016). Production & Quality Control of ^123I Radiopharmaceuticals, IAEA-TECDOC-1806.

[4] NTP Radioisotopes. (2022). Radioisotope Production Capabilities. Retrieved from https://www.ntp.co.za

[5] Mallinckrodt Pharmaceuticals. (2021). Radiopharmaceuticals Portfolio. Retrieved from https://www.mallinckrodt.com

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The sourcing of I-123 iodohippurate sodium API remains a complex but vital component of nuclear medicine diagnostics. Strategic partnerships, technological innovations, and regional production initiatives are poised to meet growing clinical demands.