Bulk Pharmaceutical API Sources for MPI INDIUM DTPA IN 111

Bulk Pharmaceutical API Sources for MPI INDIUM DTPA IN 111

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1264751
THE BioTek		bt-1596850
Starshine Chemical		2023-05-5H07419
RR Scientific		R6374421

Bulk Active Pharmaceutical Ingredient (API) Sources for: MPI Indium DTPA In-111

Last updated: November 19, 2025

Introduction

Indium-111 (In-111) labeled compounds like MPI Indium DTPA are pivotal in nuclear medicine, primarily used for diagnostic imaging. The efficacy of these radiopharmaceuticals hinges on the reliable availability of high-quality Active Pharmaceutical Ingredients (APIs), notably Indium DTPA. Securing reputable sources of bulk API is essential for pharmaceutical manufacturers aiming to produce consistent, safe, and effective radiopharmaceuticals. This report explores primary global sources of Indium DTPA, with a focus on providers that supply high-grade bulk APIs suitable for clinical and commercial radiopharmaceutical production.

Understanding MPI Indium DTPA In-111

MPI Indium DTPA is a radiopharmaceutical agent where Indium-111 (a gamma emitter with a half-life of approximately 2.8 days) attaches to DTPA (diethylenetriaminepentaacetic acid). This conjugation forms a complex exploited for imaging conditions such as tumor localization, infection monitoring, and renal function assessment. The stability and purity of the Indium DTPA complex directly impact imaging quality and patient safety.

MPI (Molecular Pathology Inc., USA) is known for developing specific radiopharmaceuticals, including In-111 DTPA kits. However, the critical component—the Indium DTPA ligand—must be sourced from reliable bulk API suppliers to assure quality, stability, and regulatory compliance.

Global API Suppliers for Indium DTPA

1. International Chemical Suppliers

While the API for In-111 DTPA synthesis generally requires complex organic chelators or metal complexes, the primary raw material—Indium-111—is supplied by specialized radiochemical vendors. Suppliers that provide bulk In-111 encompass isotope producers, whereas chemical vendors supply DTPA and related chelating agents.

Key Suppliers of DTPA and Indium-111

• Sigma-Aldrich / Merck Millipore

  A global leader in chemical manufacturing, Sigma-Aldrich supplies pharmaceutical-grade DTPA (disodium diethylenetriaminepentaacetate) suitable for radiolabeling processes. They provide high-purity, pharmaceutical-grade DTPA, available in bulk quantities. These supplies are compatible with GMP standards, ensuring suitability for radiopharmaceutical synthesis.

• Fischer Scientific

  Offers pharmaceutical and analytical grade DTPA, often used in radiochemistry research and clinical production. They supply DTPA in bulk, with specifications conforming to regulatory standards necessary for radiopharmaceutical development.

• Toronto Research Chemicals

  Provides DTPA with high purity levels suitable for clinical and research applications, making them a potential bulk API source for preparation of Indium DTPA complexes.

2. Specialized Radiochemical Isotope Suppliers

• PerkinElmer (PerkinElmer Radioisotopes)

  As a leading supplier of medical isotopes, PerkinElmer produces and supplies Indium-111 in various quantities. While primarily an isotope vendor, they collaborate with radiopharmaceutical manufacturers for the supply of in-house prepared Indium-111 suitable for radiolabeling.

• Curium Photonics and Nordion

  Both companies are involved in producing and distributing medical isotopes, including Indium-111. They typically supply in clinical or bulk quantities to licensed radiopharmacies and manufacturing units.

3. Contract Manufacturers and Custom API Providers

• Polatom (Poland)

  Poland-based Polatom is a significant producer of medical radioisotopes, including Indium-111, for international distribution. They supply isotopes suitable for radiolabeling purposes, adhering to GMP standards.

• IDB (International Dispensary Bureau) and Isotope Providers

  Many regional and specialized vendors facilitate custom API synthesis of Indium complexes or supply recombinant DTPA for radiolabeling. These entities often operate under strict regulatory oversight, catering to multinational pharmaceutical firms.

4. Chemical Manufacturers of DTPA Chelators

• ACROS Organics, Alfa Aesar, and other chemical distributors

  Distribute high-purity DTPA chelators in bulk. While mainly supplied for research, these can be scaled for pharmaceutical manufacturing, provided proper validation and regulatory compliance are observed.

Regulatory and Quality Considerations

Securing a reliable source of API for In-111 DTPA necessitates adherence to Good Manufacturing Practice (GMP) standards. Suppliers must demonstrate lot-to-lot consistency, high purity levels, and proper documentation compatible with regulatory submissions (FDA, EMA, etc.).

Bulk APIs intended for radiopharmaceuticals are often classified as sterile, radiochemically pure, and compliant with pharmacopeial guidelines (USP, EP, JP). Suppliers must also provide comprehensive Certificates of Analysis (CoA), stability data, and manufacturing process documentation.

Emerging Trends and Future Sources

The increasing global demand for nuclear medicine diagnostics underpins efforts to diversify API sources. Emerging regional providers in Asia and Eastern Europe are scaling up their GMP-compliant API production. Innovations involve the development of more stable and higher yield chelating agents, reducing manufacturing costs and enhancing supply chain resilience.

Conclusion

The primary sources for bulk active ingredients necessary for MPI Indium DTPA In-111 production comprise reputable chemical suppliers for DTPA chelators, industry-leading isotope vendors for Indium-111, and specialized radiopharmaceutical contract manufacturers. Ensuring supply chain integrity, regulatory compliance, and high product purity remains critical for success in radiopharmaceutical manufacturing.

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Key Takeaways

• Reliable API sourcing for MPI Indium DTPA In-111 involves a combination of high-purity DTPA chelators and Indium-111 isotopes, supplied by established GMP-compliant vendors.

• Leading chemical suppliers such as Sigma-Aldrich and Alfa Aesar provide bulk DTPA suitable for radiolabeling processes, while isotope vendors like PerkinElmer and Nordion supply high-quality Indium-111.

• Regulatory compliance is paramount, with suppliers needing to furnish Certificates of Analysis and documentation aligning with pharmacopeial and regulatory standards.

• Emerging regional producers are enhancing supply diversification, with new sources in Asia and Europe offering competitively priced, GMP-grade APIs.

• Partnerships with contract manufacturing organizations (CMOs) can facilitate the production of radiolabeled forms, ensuring API quality and consistent production quality control.

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FAQs

1. What are the primary considerations when sourcing API for MPI Indium DTPA In-111?
Manufacturers must prioritize API purity, regulatory compliance, lot-to-lot consistency, and supplier certification to ensure radiopharmaceutical safety and efficacy.

2. Can DTPA chelators from chemical suppliers be directly used for radiolabeling with Indium-111?
Yes, pharmaceutical-grade DTPA chelators from reputable chemical suppliers are suitable for radiolabeling, provided they meet pharmacopeial standards and are handled following proper radiochemistry protocols.

3. Are regional suppliers available for bulk Indium-111?
Yes, regional isotope producers in Europe, Asia, and North America supply Indium-111 in bulk, catering to local and international markets under regulatory oversight.

4. How does regulatory compliance influence supplier selection?
Suppliers must demonstrate GMP compliance, provide detailed Certificates of Analysis, and adhere to pharmacopoeial standards to ensure their API is suitable for clinical use.

5. What future developments could impact API sourcing for MPI Indium DTPA?
Advances in radiochemistry, new chelating agents, and regional manufacturing capacity expansion could improve supply stability and reduce costs, supporting broader adoption of In-111 radiopharmaceuticals.

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References

[1] International Atomic Energy Agency. "Production and Quality Control of Radionuclides for Medical Applications," IAEA, 2019.
[2] USP Monographs. "Diethylenetriaminepentaacetic Acid (DTPA)," United States Pharmacopeia, 2022.
[3] Sigma-Aldrich Product Information. "DTPA Disodium Salt," 2023.
[4] PerkinElmer. "Indium-111 Clarity," 2023.
[5] European Pharmacopoeia. "Radiopharmaceutical Standards," 2022.