Bulk Pharmaceutical API Sources for iodohippurate sodium i-131

Bulk Pharmaceutical API Sources for iodohippurate sodium i-131

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23663553
BenchChem		B1262144
THE BioTek		bt-1594302

Bulk Active Pharmaceutical Ingredient (API) Sources for: Iodohippurate Sodium I-131

Last updated: July 27, 2025

---

Introduction

Iodohippurate sodium I-131 (I-131 HIP) is a radiopharmaceutical widely used in nuclear medicine, particularly for renal imaging and functional assessment. As a radioactive iodine-labeled compound, its synthesis and availability hinge on the sourcing of high-purity active pharmaceutical ingredient (API). Reliable, compliant API suppliers ensure consistent quality, regulatory adherence, and supply chain stability for this specialized compound.

---

Understanding Iodohippurate Sodium I-131

I-131 HIP is a complex radiotracer composed of iodine-131 conjugated to hippurate sodium salt. It is predominantly used in renal scintigraphy to evaluate renal perfusion, function, and drainage, thanks to its favorable pharmacokinetics and imaging qualities. The API sourcing for I-131 HIP involves the procurement of iodine-131 and the precursor hippurate sodium compound, followed by chemical conjugation processes conducted under strict Good Manufacturing Practice (GMP) standards.

---

API Components Critical for Iodohippurate Sodium I-131

1. Iodine-131 (I-131)

I-131 is a radioactive isotope with a half-life of approximately 8 days, emitting both beta particles and gamma rays. It is crucial for radiopharmaceutical applications, demanding high purity, specific activity, and compliance with nuclear regulatory standards. Commercial availability of I-131 typically stems from reactor-based production, with suppliers offering bulk bullion or ready-to-use radiochemical solutions.

2. Hippurate Sodium

Hippurate sodium (sodium phenylacetylglycinate) serves as the unlabeled precursor. Its procurement involves organic synthesis and purification processes to ensure pharmaceutical-grade quality. The purity, stereoselectivity, and stability of hippurate sodium influence the efficacy and safety of the final radiopharmaceutical.

---

Global API Suppliers for Iodine-131 and Hippurate Sodium

A. Sources of Iodine-131

1. NTP Radioisotopes (USA)
A leading supplier providing high-purity I-131 for medical use. Their products adhere to stringent nuclear standards, offering both bulk iodine and ready-to-use formulations. NTP's I-131 is frequently used in clinical radiopharmacy due to its verified quality and reliable supply.

2. PerkinElmer (USA & Europe)
PerkinElmer supplies a broad portfolio of radioisotopes, including I-131, primarily aimed at diagnostic and therapeutic applications. Their isotopes meet international standards such as USP, EP, and JP, with established GMP manufacturing lines for medical-grade I-131.

3. Eckert & Ziegler (Germany)
A major global supplier of radioisotopes, Eckert & Ziegler offers high-purity I-131 suitable for radiopharmaceutical synthesis. Their products are characterized by rigorous quality controls aligned with IAEA safety standards.

4. BRIT (India)
The Board of Radiation & Isotope Technology (BRIT) produces I-131 for medical and industrial applications. They supply both bulk iodine and radiochemicals conforming to Indian and international specifications, serving markets across Asia.

5. Covidien (now part of Medtronic, USA)
Offers I-131 for diagnostic and therapeutic purposes, maintaining adherence to GMP standards. They ensure supply chain security and regulatory compliance for global markets.

B. Sources of Hippurate Sodium

1. Spectrum Chemical & Laboratory Products (USA)
Provides pharmaceutical-grade hippurate sodium, synthesized under GMP. Spectrum Chemical offers high purity, analytical certificates, and reliable supply chains suitable for radiopharmaceutical preparation.

2. Merck KGaA (Germany)
Merck supplies high-quality organic intermediates, including hippurate sodium. Their active ingredients are manufactured under stringent quality controls, with extensive regulatory documentation.

3. Alfa Aesar (USA)
A reliable source for specialty chemicals, offering pharmaceutical or research-grade hippurate sodium. Their products are compliant with pharmacopoeial standards, ensuring suitability for subsequent radiolabeling.

4. Sigma-Aldrich (USA & Europe)
Part of Merck Group, Sigma-Aldrich supplies pharmaceutical-grade hippurate sodium, used in academic, clinical, and GMP-approved radiopharmaceutical syntheses.

---

Regulatory and Quality Considerations

Sourcing API for I-131 HIP demands compliance with pharmacopoeial standards (USP, EP, JP) and regulatory frameworks such as those enforced by the FDA, EMA, and other national agencies. Suppliers must provide Certificates of Analysis (CoA), stability data, and documentation demonstrating current Good Manufacturing Practice (cGMP) adherence. For radioactive APIs, additional certification aligning with the International Atomic Energy Agency (IAEA) safety standards is required.

It is prudent to establish sourcing relationships with suppliers holding GMP certification, documented QA/QC procedures, and proven track records in radiopharmaceutical manufacturing. Due to the radioactive nature of iodine-131, supplier quality assurance extends to radiation safety protocols, traceability, and compliance with nuclear regulatory authorities.

---

Supply Chain and Procurement Challenges

Despite a relatively niche market, the procurement of I-131 API components faces challenges including fluctuating reactor outputs, regulatory restrictions, geopolitical factors, and safety compliance. Long-term supply agreements with multiple suppliers mitigate risks of shortages. The specialized nature of hippurate sodium also demands rigorous screening for purity, stability, and consistent bioavailability.

Emerging technologies, such as cyclotron production of certain radioisotopes, are unlikely to replace reactor-based I-131 in the near term, thus maintaining reliance on established suppliers with nuclear licensing. Additionally, manufacturers may consider integrating APIs from multiple sources or utilizing intermediates to ensure continuous supply.

---

Emerging Trends and Future Outlook

The global demand for I-131-based therapies and diagnostics underscores the importance of robust API sourcing strategies. Investment in new reactor facilities and alternative production methods aim to enhance supply security. Companies innovating in synthesis, purification, and formulation are expected to offer higher-purity APIs with reduced radiation safety concerns.

Furthermore, advancements in radiopharmaceutical chemistry could facilitate the development of novel conjugates, potentially altering API sourcing paradigms. However, for I-131 HIP specifically, the existing supply infrastructure remains vital due to regulatory and safety considerations.

---

Key Takeaways

• The primary APIs required for I-131 HIP synthesis are high-purity iodine-131 and hippurate sodium.
• Reputable global suppliers include NTP Radioisotopes, PerkinElmer, Eckert & Ziegler, BRIT, Spectrum Chemical, and Merck.
• Rigorous quality assurance, cGMP compliance, and regulatory certifications are essential for API sourcing.
• Supply chain stability depends on long-term relationships with multiple suppliers, considering geopolitical and regulatory factors.
• Ongoing technological developments are expected to enhance supply security and API purity levels in the future.

---

FAQs

1. What are the major challenges in sourcing API components for I-131 HIP?
The primary challenges include regulatory compliance, ensuring high purity and activity of I-131, supply chain disruptions due to geopolitical factors or reactor availability, and maintaining strict safety standards for radioactive materials.

2. Can I-131 API be sourced directly from commercial suppliers for clinical use?
Yes. Several suppliers provide GMP-grade I-131, suitable for radiopharmaceutical synthesis, subject to regulatory approvals and compliance with national nuclear safety standards.

3. How critical is the purity of hippurate sodium in the synthesis of I-131 HIP?
Extremely critical. Impurities can affect radiolabeling efficiency, image quality, and patient safety. Therefore, sourcing pharmaceutical-grade hippurate sodium with rigorous quality documentation is mandatory.

4. What regulatory considerations influence API sourcing for radiopharmaceuticals?
Suppliers must comply with GMP, nuclear safety standards, and pharmacopoeial quality requirements. Additionally, documentation such as COA, safety data sheets, and regulatory certificates are mandatory.

5. Are there alternative sources or methods emerging for I-131 API production?
Currently, reactor-based production remains dominant. Research into cyclotron-based methods is ongoing but not yet commercially viable for I-131 at scale. The emphasis remains on improving reactor supply and manufacturing processes.

---

References

[1] International Atomic Energy Agency (IAEA). "Radioisotopes for Medical Use," IAEA Safety Standards, 2020.
[2] NTP Radioisotopes. "High Purity Iodine-131 Products," Product Catalog, 2022.
[3] PerkinElmer. "Radioisotope Solutions," Company Brochure, 2022.
[4] Eckert & Ziegler. "Medical Radioisotopes," Product Information Sheet, 2021.
[5] Merck KGaA. "Pharmaceutical Ingredients," Catalog, 2022.