TECHNETIUM TC-99M APCITIDE bulk active fine chemical suppliers

Subscribe to access the full database, or Get Started Free
Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences	⤷ Get Started Free	178959-14-3	⤷ Get Started Free
>Vendor	>Vendor Homepage	>Vendor Sku	>API Url

Last updated: August 9, 2025

Introduction

Technetium-99m (Tc-99m) remains the cornerstone of nuclear medicine, accounting for approximately 80-85% of all diagnostic nuclear imaging procedures globally[1]. Its utility stems from ideal physical properties, including a short half-life of 6 hours, emission of a 140 keV gamma photon suitable for imaging, and straightforward production via decay of molybdenum-99 (Mo-99). As a radiopharmaceutical, Tc-99m is commonly derived from technetium-99m generator systems, primarily utilizing molybdenum-99 as the parent isotope.

While Tc-99m itself is produced in generator systems at clinical sites, the phosphor tin colloid formulation, often labeled with Tc-99m for lymphoscintigraphy or other diagnostic applications, involves the use of bulk active pharmaceutical ingredients (APIs). Securing reliable, compliant API sources for phosphor tin colloid is crucial for manufacturers and healthcare providers. This article analyzes the available bulk API sources for Tc-99m-based phosphor tin colloid, assessing their manufacturing capabilities, regulatory status, and supply chain considerations.

Understanding Technetium-99m Phosphor Tin Colloid

Phosphor tin colloid consists of finely dispersed tin-based particles suspended within a colloidal matrix, typically stabilized with phosphates or other stabilizers. When labeled with Tc-99m, it facilitates visualization of lymphatic systems, spleen, and bone marrow. The critical API components include:

Tin colloid (usually tin(II) chloride or tin(II) sulfate stabilized colloid)
Phosphor component (commonly phosphate ions)
The technetium-99m radionuclide, often obtained from Mo-99/Tc-99m generators

In this context, we primarily focus on the bulk tin colloid API used in manufacturing Tc-99m phosphor tin colloid radiopharmaceuticals.

Major API Suppliers for Tin-Based Colloids in Tc-99m Phosphor Tin Colloid Production

1. Cerilliant Corporation

Overview: As a leading provider of certified reference materials and specialty chemicals, Cerilliant supplies high-purity chemicals for radiopharmaceutical manufacturing, including various tin compounds.

API Offerings:
Cerilliant offers "Tin(II) chloride dihydrate" and related tin salts with high purity grades suitable for radiopharmaceutical use. Their API products typically meet USP, EP, and other pharmacopeial standards, ensuring consistency and compliance for API manufacturing.

Supply Chain & Regulatory Status:
Cerilliant maintains strict quality controls and supply chain robustness, serving clients worldwide. Their APIs are suitable for use in licensed radiopharmacies and manufacturing facilities compliant with cGMP standards:

Good Manufacturing Practice (GMP) compliant APIs
Certificates of Analysis (COA) and regulatory documentation provided

2. Sigma-Aldrich (MilliporeSigma)

Overview:
A global leader in life sciences, Sigma-Aldrich supplies a range of chemical reagents, including tin salts used in radiopharmaceutical synthesis.

API Offerings:
Their “Tin(II) chloride dihydrate” and related chemicals are available as analytical-grade or pharmaceutical-grade products, with lots suitable for injectable radiopharmaceuticals after appropriate validation.

Supply Chain & Regulatory Status:
Sigma-Aldrich maintains a vast distribution network supporting rapid delivery. Their APIs are often used in clinical and research settings, with documentation that facilitates regulatory approval and compliance.

3. APIC Laboratories

Overview:
Specializing in radiopharmaceutical components, APIC Laboratories provides custom synthesis and sourcing of tin colloids.

API Offerings:
APIC supplies colloidal tin solutions formulated specifically for radiopharmaceutical applications, adhering to cGMP standards. Their APIs are often tailored for specific formulations and yield applications in Tc-99m labelling.

Supply Chain & Regulatory Status:
APIC’s APIs are furnished with comprehensive documentation, quality certifications, and regulatory compliance suited for pharmaceutical manufacturing.

4. Jubilant Radiopharma and Mallinckrodt

Overview:
Both companies are prominent Mo-99/Tc-99m generator vendors with extensive supply chains for radiopharmaceutical raw materials, including APIs used in manufacturing phosphor tin colloid.

API Offerings:
While primarily known for generator systems, they also supply bulk chemicals such as tin compounds for manufacturing purposes, facilitating primary API sourcing directly aligned with their generator products.

Regulatory Status:
Their APIs are produced under stringent GMP conditions, with extensive regulatory approval status across multiple jurisdictions.

Emergence of Regional API Manufacturers

The radiopharmaceutical market is seeing increased regionalization, particularly in Asia-Pacific, driven by supply chain resilience concerns and regulatory adaptations. Chinese and Indian API manufacturers are increasingly entering the space with high-grade tin compounds:

Hubei Wuling Fine Chemicals (China)
Sun Pharmaceuticals (India)

These manufacturers offer competitively priced APIs that meet pharmacopeial standards, although validation and regulatory approval are crucial factors for market acceptance.

Key Supply and Regulatory Considerations

Quality and Purity: APIs must meet strict pharmaceutical-grade standards, with evidence of metal purity, endotoxin levels, and absence of undesirable contaminants.
Regulatory Approvals: Suppliers should possess appropriate cGMP certifications, and APIs should come with comprehensive documentation, including COA and stability data.
Supply Chain Reliability: Given the short half-life of Tc-99m, timely delivery is essential. Suppliers with local manufacturing capabilities and distribution networks reduce delays.
Compatibility with Manufacturing Processes: APIs should be compatible with established colloid preparation protocols, ensuring reproducibility and safety.

Manufacturing Process and API Quality Control

The production of phosphor tin colloid involves precise control of tine salt quality, colloid particle size, and stabilization conditions. The primary API—tin(II) chloride dihydrate or tin(II) sulfate—must be sourced from reputable suppliers to ensure:

Consistency across batches
Minimized ionic impurities
Compatibility with analytical specifications

Quality control testing includes spectrophotometry, atomic absorption spectroscopy (AAS) for metal content, and microbial testing.

Regulatory and Compliance Landscape

Manufacturers sourcing APIs for Tc-99m phosphor tin colloid should verify compliance with regional regulatory authorities such as the FDA (U.S.), EMA (Europe), and PMDA (Japan). The APIs must also satisfy international standards like USP, EP, or JP monographs, depending on the market.

Proper documentation and validation of APIs are indispensable, ensuring they align with current Good Manufacturing Practice (cGMP) standards and facilitate approval pathways in target markets.

Future Outlook and Market Dynamics

The API sourcing environment for Tc-99m phosphor tin colloid is poised for continued evolution, driven by:

Geopolitical factors affecting isotope and raw material supply chains
Regulatory tightening requiring higher API quality standards
Emergence of regional manufacturing hubs offering localized API production
Innovation in radiopharmaceutical formulations potentially reducing dependency on tin colloids or enabling alternative labeling methods

Global collaborations and supply agreements are likely to become more critical in ensuring consistent, high-quality API availability.

Key Takeaways

Reliable bulk API sources for Tc-99m phosphor tin colloid are primarily from established chemical suppliers like Cerilliant, Sigma-Aldrich, and regional manufacturers in Asia-Pacific.
Ensuring APIs meet pharmacopeial and cGMP standards is critical to regulatory compliance and batch-to-batch consistency.
Supply chain resilience is vital given Tc-99m’s short half-life; regional and local suppliers offer strategic advantages.
The rising regionalization of API manufacturing and increased regulatory scrutiny necessitate comprehensive validation, documentation, and supplier qualification.
Future market stability hinges on innovations in radiopharmaceutical chemistry, alternative formulations, and diversified API sourcing strategies.

FAQs

1. How does the quality of tin API influence the stability of Tc-99m phosphor tin colloid?
High-purity, pharmacopeial-grade tin API ensures stable colloid formation, reproducible particle size, and minimal impurity-induced degradation, directly impacting imaging quality and patient safety.

2. Can regional API suppliers meet international regulatory standards for radiopharmaceutical production?
Yes, many regional suppliers produce APIs compliant with cGMP and pharmacopeial standards, but validation and qualification processes are essential for regulatory clearance.

3. What are the main challenges in sourcing bulk tin APIs for radiopharmaceutical manufacturing?
Challenges include maintaining quality consistency, supply chain disruptions, regulatory compliance, and ensuring API compatibility with specific colloid preparation protocols.

4. Are there alternatives to tin-based colloids for Tc-99m labeling?
Yes, alternative formulations such as sulfide or other colloids are under development, but tin colloids remain the most established and widely used.

5. What is the impact of geopolitical factors on the API supply chain for Tc-99m phosphor tin colloid?
Geopolitical issues can lead to supply shortages or delays, emphasizing the importance of diversified sourcing, regional manufacturing, and strategic reserves to ensure supply continuity.

References

[1] IAEA. "Production and Quality Control of Technetium-99m." International Atomic Energy Agency, 2019.

Bulk Pharmaceutical API Sources for technetium tc-99m apcitide