Bulk Pharmaceutical API Sources for MPI DTPA KIT - CHELATE

Bulk Pharmaceutical API Sources for MPI DTPA KIT - CHELATE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jmkph@BZRADeAct\uyELhdhcDeDXdhhuUSUTuULp@@
Sigma-Aldrich		D6518_SIAL
MP Biomedicals		207981
NovoSeek		3053

Bulk Active Pharmaceutical Ingredient (API) Sources for: MPI DTPA KIT - CHELATE

Last updated: August 9, 2025

Introduction

The MPI DTPA Kit – Chelate is a diagnostic tool used predominantly in nuclear medicine and radiopharmaceutical applications. It leverages the chelating properties of Diethylenetriaminepentaacetic acid (DTPA) to bind metal ions such as technetium-99m, facilitating organ imaging and diagnostic procedures. Central to manufacturing these kits is sourcing high-quality bulk API, specifically DTPA in pharmaceutical-grade purity. Reliable API sourcing ensures product efficacy, safety, regulatory compliance, and consistent supply chain performance. This report analyzes the global landscape for DTPA API suppliers, assessing their capacities, regulatory status, and strategic positioning.

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Understanding DTPA API in MPI DTPA Kits

Chemical Profile and Functionality

DTPA (Diethylenetriaminepentaacetic acid) is a pentadentate chelating agent that forms stable complexes with various metal ions, especially technetium-99m. Its role in MPI kits involves efficient chelation, enabling radiolabeling with minimal free radioactivity, ultimately enhancing image clarity and diagnostic accuracy. As an API, DTPA must meet stringent pharmaceutical standards, including high purity (>98%), specific stability profiles, and compliance with pharmacopeial monographs (USP, EP, JP).

Manufacturing and Quality Attributes

Manufacturing DTPA API demands synthesis processes that minimize impurities and residual solvents. Common synthesis routes involve multi-step chemical reactions starting from diethylenetriamine, with purification processes such as crystallization or chromatography. Quality attributes pivotal for API suppliers include pharmacopoeial compliance, batch-to-batch consistency, stability data, and validation of manufacturing processes.

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Global API Suppliers for DTPA

1. Major Pharmaceutical Raw Material Suppliers

Several global pharmaceutical ingredient manufacturers are recognized for producing high-quality DTPA API fit for radiopharmaceutical applications, including:

• Sigma-Aldrich (Merck KGaA): A leading supplier of research chemicals and pharmaceutical-grade APIs. Sigma-Aldrich's DTPA API is widely used in academia and industry, meeting USP standards, with extensive documentation on purity and safety.

• Cotation R&D (Hungary): Specializes in the synthesis of chelating agents like DTPA, with GMP-certified facilities catering to pharmaceutical manufacturers. Their DTPA API adheres to pharmacopoeial standards, with a focus on radiopharmaceutical applications.

• LGM Pharma: A global distributor providing active pharmaceutical ingredients, excipients, and intermediates, including DTPA API sourced from qualified manufacturers. LGM Pharma emphasizes regulatory compliance and supply security.

• International Chemical Investors Group (ICIG): Through its subsidiaries, ICIG supplies specialized chemicals, including chelating agents, with capabilities for bulk production of DTPA API meeting pharmaceutical standards.

2. Regional Suppliers and Niche Producers

Regional and niche suppliers play advantageous roles due to proximity to manufacturing hubs or specialized production techniques:

• Jubilant Life Sciences (India): Known for producing pharmaceutical intermediates and APIs, including chelating agents, with significant capacity and adherence to international standards.

• Chemtura Corporation (Now Lanxess, Germany): Offers specialty chemicals, including chelating agents, with an emphasis on purity suitable for injectable formulations.

• Siegfried AG (Switzerland): A contract manufacturing organization capable of custom synthesis and scale-up for DTPA API, maintaining strict quality controls.

3. Challenges in API Supply and Considerations

Securing a reliable DTPA API supply involves addressing issues such as:

• Regulatory Compliance: It's critical that suppliers possess appropriate certifications (GMP, FDA registration, EMA approval) to meet global regulatory standards for pharmaceutical APIs.

• Quality Assurance: Suppliers must provide comprehensive Certificates of Analysis (COA), stability data, and validation documentation.

• Supply Chain Security: Given the niche nature of DTPA, geopolitical factors and manufacturing capacity constraints can impact consistent availability.

• Cost and Lead Times: Pricing varies based on purity grade, batch size, and supplier location. Lead times can range from 4 to 12 weeks, depending on demand and regulatory clearances.

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Strategic Considerations for Sourcing DTPA API

• Vendor Qualification: Conduct comprehensive audits, review clinical batch records, and verify GMP compliance.

• Alternative Sourcing: Maintain relationships with multiple suppliers to mitigate supply disruptions, especially during pandemic-related shortages.

• Regulatory Alignment: Ensure vendors can support regulatory filings, provide necessary documentation, and adapt to regional requirements.

• Customization and Scale-up: Engage suppliers capable of customizing formulations or scaling production volumes based on project needs.

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Regulatory Landscape

The primary regulatory frameworks influencing API sourcing include the US FDA, EMA, and regional pharmacopoeias (USP, EP, JP). Manufacturers must ensure their APIs are validated, traceable, and accompanied by proper documentation to facilitate registration of the MPI DTPA kits.

Adherence to cGMP standards is non-negotiable, especially because radiopharmaceuticals involve patient safety considerations. Additionally, suppliers should provide stability data specific to radiolabeling applications, which impacts shelf life and storage guidelines.

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Emerging Trends and Development

Advances in synthetic methods aim to improve yield, purity, and environmental sustainability of DTPA production. Green chemistry approaches are gaining traction, reducing solvent use and waste. Moreover, the development of novel chelating agents with higher stability constants is an active research area, though DTPA remains the industry standard in MPI kits due to its proven performance.

Supply chain resilience is increasingly emphasized, with suppliers expanding capacity, investing in quality systems, and establishing regional manufacturing hubs to meet global demand.

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Key Takeaways

• The primary sources of pharmaceutical-grade DTPA API are major global suppliers such as Sigma-Aldrich, Cotation R&D, and LGM Pharma, alongside regional manufacturers like Jubilant and Lanxess.

• Selecting a reliable supplier involves evaluating GMP compliance, detailed quality documentation, and capacity for scale-up.

• Regional diversification and strategic vendor qualification are essential to mitigate supply risks and ensure regulatory adherence.

• Staying abreast of advances in API manufacturing and synthetic methodologies can improve product quality and environmental footprint.

• Regulatory compliance, thorough documentation, and supply chain resilience are critical to maintaining consistent supply for MPI DTPA kits.

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Key Takeaways

• Global sourcing of DTPA API involves assessing quality certifications, manufacturing capacity, and regulatory compliance to ensure product integrity in MPI kits.

• Major suppliers like Sigma-Aldrich and Cotation R&D provide high-purity DTPA suitable for pharmaceutical applications, but regional providers also play vital roles in supply diversification.

• Establishing multiple vendor relationships and conducting rigorous qualification procedures mitigate risks associated with supply disruptions.

• Advances in eco-friendly synthesis and formulation stability enhance the overall quality and sustainability of API supply.

• Regulatory awareness and documentation support lifecycle management, product registration, and market access for radiopharmaceutical products.

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FAQs

1. What are the critical quality specifications for DTPA API used in MPI kits?
   DTPA API must meet high purity levels (>98%), be free from residual solvents, adhere to pharmacopoeial standards (USP, EP), and demonstrate stability suitable for radiolabeling.

2. Which regions dominate DTPA API production for pharmaceutical use?
   North America (US and Canada), Europe (Germany, Switzerland), and parts of Asia (India, China) are prominent regions with GMP-capable manufacturers.

3. How do regulatory standards impact API sourcing for radiopharmaceuticals?
   APIs must comply with strict GMP guidelines, possess comprehensive documentation for regulatory review, and conform to regional pharmacopoeia standards to ensure safety and efficacy.

4. Are there sustainable alternatives or innovations in DTPA production?
   Yes, research focuses on greener synthesis routes and environmentally friendly processes to reduce waste and solvent use while maintaining high purity standards.

5. What is the typical lead time for sourcing DTPA API at commercial scales?
   Lead times generally range from 4 to 12 weeks, depending on supplier location, production capacity, and regulatory clearance processes.

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Sources

1. [1] USP Monograph for DTPA, United States Pharmacopeia.
2. [2] European Pharmacopoeia Standards for Chelating Agents, European Directorate for the Quality of Medicines & HealthCare.
3. [3] Sigma-Aldrich Product Documentation for DTPA API.
4. [4] Cotation R&D Technical Data Sheets and GMP Certifications.
5. [5] LGM Pharma API Supplier Profile and Quality Certifications.