Bulk Pharmaceutical API Sources for UREA C-13

Bulk Pharmaceutical API Sources for UREA C-13

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		299359_ALDRICH
Sigma-Aldrich		603430_ALDRICH
NovoSeek		636363
MP Biomedicals		530387
MolPort		MolPort-003-929-552
ABI Chem		AC1LCS3W
Chembase.cn		106256

Bulk Active Pharmaceutical Ingredient (API) Sources for Urea C-13

Last updated: July 28, 2025

Introduction

Urea C-13, a stable isotope-labeled compound of urea, is extensively employed in pharmaceutical research, tracer studies, and diagnostic applications. Its utility stems from its ability to serve as a non-radioactive label to investigate urea metabolism, renal function, and nitrogen balance. Given its niche but vital role, sourcing high-purity Urea C-13 in bulk quantities is critical for pharmaceutical companies, research institutions, and diagnostic laboratories. This article provides an in-depth analysis of the global suppliers, quality considerations, and procurement strategies for bulk Urea C-13 APIs.

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Overview of Urea C-13 as an API

Urea C-13, typically enriched to 99% or higher isotopic purity, is synthesized via specialized chemical processes involving the substitution of carbon atoms with the C-13 isotope. Its applications require strict compliance with pharmaceutical standards, including USP, EP, or JP monographs, ensuring purity, isotopic enrichment, and residual solvent specifications. These parameters influence the choice of API suppliers, procurement costs, and regulatory approval pathways.

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Global API Suppliers for Urea C-13

1. Cambridge Isotope Laboratories (CIL)

• Overview: As a leading provider of stable isotope-labeled compounds, CIL supplies Urea C-13 suitable for biomedical research and pharmaceutical applications.
• Product Details: CIL offers Urea C-13 with isotopic enrichment typically ≥99% and high chemical purity standards (HPLC-grade). The company's manufacturing process ensures batch-to-batch consistency.
• Quantity & Customization: CIL provides various sizes—from small research quantities to multi-kilogram bulk orders—enabling flexible procurement for different scales.
• Regulatory & Quality: CIL maintains ISO 9001 certification, adhering to Good Manufacturing Practices (GMP), and supplies certificates of analysis compliant with pharmaceutical standards.
• Application Focus: Predominantly targeted at research institutions, but their high-quality standards make their API suitable for clinical research and even early-phase pharmaceutical development.

2. Sigma-Aldrich/Merck

• Overview: A global leader in chemical and biochemical supply, Sigma-Aldrich offers isotopically labeled compounds, including Urea C-13.
• Product Details: Their Urea C-13 typically exhibits ≥99% isotopic purity, with specifications aligned to analytical and clinical research needs.
• Bulk Availability: While primarily serving research markets, Sigma-Aldrich can fulfill larger bulk orders via dedicated contract manufacturing mechanisms.
• Quality & Compliance: Their products meet international standards, with comprehensive documentation supporting regulatory submissions.
• Application Focus: Primarily research and diagnostic applications; pharmaceutical grade versions are available upon inquiry.

3. IsoSciences LLC

• Overview: Specializing in isotopic compounds, IsoSciences provides a range of labeled chemicals, including Urea C-13.
• Product Details: They supply high-enrichment Urea C-13 with purity suitable for clinical and pharmaceutical research.
• Custom Synthesis: Capable of producing tailored isotopic enrichment levels and specific isotopic labeling patterns.
• Regulatory & Quality Assurance: ISO-certified processes ensure consistent quality and regulatory compliance.
• Application Focus: Focused on clinical research, metabolic studies, and diagnostic kits.

4. Cambridge Pharmaceuticals Ltd. (USA/UK)

• Overview: Known for custom synthesis of labeled compounds, they provide high-quality isotopic APIs including Urea C-13.
• Product Features: High isotopic enrichment, high chemical purity, and low residual solvents.
• Bulk Supply Capacity: Suitable for large-scale clinical trials and pharmaceutical R&D.
• Regulatory Compliance: Adheres to required pharmaceutical standards, aiding in IND filings and product development.

5. Other Notable Suppliers

• Cambridge Isotope Laboratories (CIL), IsoSciences, Aurora Fine Chemicals, and other niche providers continue to supply high-value isotopically labeled compounds, including Urea C-13, to pharmaceutical and biotech clients globally. These sources often provide custom synthesis capabilities, including specific isotopic enrichment levels, isotopologue distributions, and tailored impurity profiles.

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Quality and Compliance Considerations

When sourcing Urea C-13 for pharmaceutical use, strict adherence to quality standards is imperative. Suppliers must demonstrate compliance with cGMP, ISO certifications, and provide detailed certificates of analysis. Key specifications include:

• Isotopic enrichment: ≥99% preferred for high-precision biochemical studies.
• Chemical purity: Typically ≥99%, with limits on residual solvents, heavy metals, and impurities.
• Residual solvents and contaminants: Should meet ICH Q3C guidelines.
• Batch consistency: Essential for reproducibility, especially in clinical protocols.

Procurement should involve validation of supplier regulatory documentation, audits, and conforming with local regulatory authorities such as the FDA, EMA, or PMDA.

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Pricing Dynamics and Lead Times

The cost of bulk Urea C-13 varies based on isotopic enrichment, purity, volume, and supplier. Generally, higher enrichment levels and larger bulk quantities lead to lower unit costs due to economies of scale. Lead times can range from several weeks to months, contingent on synthesis complexity and regulatory approvals. Early engagement and detailed specifications facilitate smoother procurement.

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Supply Chain Challenges

• Limited Suppliers: The niche nature of Urea C-13 restricts the number of reputable suppliers, potentially impacting supply security.
• Custom Synthesis Lead Time: High enrichment levels require sophisticated synthesis, extending turnaround times.
• Regulatory Compliance: Navigating differing international standards necessitates thorough documentation and validation.

Proactive planning and establishing strategic supplier relationships mitigate these challenges.

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Emerging Trends and Future Outlook

The growing demand for non-radioactive tracers and advanced diagnostic tools continues to boost the need for high-quality Urea C-13 APIs. Advancements in synthesis technologies and regulatory acceptance of isotope-labeled compounds are expanding the supplier base. Additionally, collaborations between academia and industry increasingly focus on developing standardized, cost-effective production processes.

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Key Takeaways

• Global supplier options like Cambridge Isotope Laboratories, Sigma-Aldrich, and IsoSciences provide high-purity Urea C-13 suitable for pharmaceutical and research applications.
• Quality assurance and regulatory compliance remain paramount; suppliers must furnish appropriate certificates and adhere to cGMP standards.
• Pricing is influenced by isotopic enrichment levels, purity, volume, and sourcing complexity; early planning can optimize procurement costs.
• Supply chain risks necessitate supplier diversification and proactive inventory management.
• The future of Urea C-13 sourcing hinges on technological innovations, regulatory acceptance, and increasing demand for isotope-labeled compounds in personalized medicine and diagnostics.

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FAQs

1. What is the typical isotopic enrichment level of bulk Urea C-13 suppliers?
Most suppliers offer Urea C-13 with ≥99% isotopic enrichment, suitable for precise metabolic and diagnostic applications.

2. Can Urea C-13 be used directly as an injectable pharmaceutical?
No. Bulk Urea C-13 is primarily used in research and diagnostic settings. Additional purification and regulatory approval are necessary for direct pharmaceutical use.

3. How long does it take to procure bulk Urea C-13?
Lead times typically range from 4 to 12 weeks, depending on the synthesis complexity, volume, and regulatory requirements.

4. Are there regional restrictions on importing Urea C-13?
Import restrictions vary; regulatory compliance with local drug, diagnostics, and customs regulations must be verified prior to procurement.

5. Is there a trend towards local sourcing of Urea C-13?
While some regions are exploring local synthesis to reduce reliance on imports, the global limited supplier base currently sustains most Urea C-13 supply chains.

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References

[1] Cambridge Isotope Laboratories, "High-Purity Urea C-13," Product brochure, 2022.
[2] Sigma-Aldrich, "Isotopically Labeled Urea," Technical datasheet, 2023.
[3] IsoSciences LLC, "Custom Isotopic Synthesis," Company website, 2023.
[4] ICH Q3C(R7) Impurities: Guideline for Residual Solvents, 2020.
[5] U.S. Food and Drug Administration, "Guidance for Industry: Stability Testing of Biotechnological/Biological Products," 2020.