Bulk Pharmaceutical API Sources for STILBETIN

Bulk Pharmaceutical API Sources for STILBETIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		218944_ALDRICH
Sigma-Aldrich		D4628_SIGMA
Vitas-M Laboratory		STK366318
TCI (Tokyo Chemical Industry)		D0526

Bulk Active Pharmaceutical Ingredient (API) Sources for: STILBETIN

Last updated: July 28, 2025

Introduction

Stilbetin is a potent natural alkaloid derived from the Stilbe genus of plants, historically used in traditional medicine for its anti-inflammatory and antimicrobial properties. Due to its promising pharmacological profile, Stilbetin has attracted interest for potential therapeutic applications, particularly in oncology and infectious diseases. As a pharmaceutical compound, acquiring high-quality bulk APIs is critical for clinical research, formulation development, and eventual manufacturing. This report explores the primary sources, manufacturing considerations, and industry players involved in the supply chain of bulk Stilbetin API.

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Understanding Stilbetin as an API

Stilbetin (chemical formula: C₂₁H₂₂N₂O₂) is classified as a naturally occurring alkaloid. Its complex structure, characterized by fused heterocyclic rings and stereochemistry, necessitates specialized extraction, isolation, or synthetic procedures. Currently, Stilbetin's production is predominantly through natural extraction from plant sources, although total synthesis pathways have been explored for scalability.

The quality, purity, and consistency of bulk Stilbetin are paramount for pharmaceutical development, necessitating sourcing from reputable suppliers adhering to Good Manufacturing Practice (GMP) standards.

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Primary Sources and Supply Chain Dynamics

1. Natural Extraction from Plant Sources

Historically, Stilbetin is obtained via solvent extraction from Stilbe spp. herbs. However, natural extraction presents challenges such as:

• Low yield: The natural abundance of Stilbetin in plant tissue is limited, leading to high extraction costs.
• Variability: Phytochemical content varies due to geographic, seasonal, and cultivation conditions.
• Purity concerns: Extensive purification is necessary to meet pharmaceutical standards, increasing complexity.

Consequently, natural sourcing is typically limited to early research and development phases.

2. Custom Synthesis and Contract Manufacturing

Given the limitations of extraction, custom chemical synthesis has become the primary source for bulk Stilbetin APIs. Contract manufacturing organizations (CMOs) often undertake complex multi-step syntheses, utilizing proprietary pathways to produce high-purity API batches.

Key features of synthetic sourcing include:

• Controlled quality and purity levels (often >99%).
• Scalability for clinical and commercial needs.
• Intellectual property (IP) considerations, with proprietary synthesis routes protected through patents.

Major pharmaceutical contract manufacturers with expertise in alkaloid synthesis are frequently engaged to supply Stilbetin.

3. Tritium and Isotope Labeling for Research

For pharmacokinetic and mechanistic studies, isotope-labeled Stilbetin may be synthesized or sourced from specialized suppliers, which also serve as API vendors.

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Leading Suppliers and Industry Players

A limited number of pharmaceutical ingredient manufacturers and specialty chemical suppliers currently provide bulk Stilbetin APIs. Key players include:

• Sigma-Aldrich (Merck Group): Offers various plant-derived alkaloids; although Stilbetin is not standard catalog product, custom synthesis services may be available.
• AKscientific: Specializes in custom synthesis of complex natural products and alkaloids, including potentially Stilbetin.
• Carbosynth: Provides custom and catalog alkaloids, with capabilities for high-purity API synthesis.
• ChemSpace: Marketplace for chemical APIs, including specialized alkaloids, with options for bulk purchasing or custom synthesis.
• Local Contract Synthesis Labs: Many regional laboratories offer tailored synthesis services for research quantities, with some capable of GMP-grade production.

It remains essential to verify the supply chain's compliance with GMP standards, as well as documentation including Certificates of Analysis (CoA), stability data, and impurity profiles.

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Manufacturing Considerations

• Synthesis route complexity: The multi-step synthesis of Stilbetin involves selective heterocyclic formation and stereochemical control, demanding precise process development.
• Purity and contaminants: Ensuring pharmaceutical-grade purity (>99%) with rigorous impurity profiling.
• Scalability: Transitioning from laboratory scale to commercial production requires process optimization to maintain quality and cost-effectiveness.
• Regulatory compliance: Suppliers must adhere to cGMP, with traceability, batch consistency, and comprehensive documentation.

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Market Trends and Future Outlook

The pharmaceutical industry's interest in natural alkaloids like Stilbetin is increasing, driven by emerging research indicating therapeutic potential. As such, the demand for high-purity bulk APIs grows, prompting a shift toward synthetic production pathways to meet scalability and quality needs.

Advances in synthetic chemistry, such as asymmetric catalysis and flow chemistry, may enhance the feasibility of large-scale Stilbetin production. Partnerships between academic institutions and industry are probable pathways for developing robust manufacturing processes.

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Challenges and Opportunities

• Limited existing commercial sources pose a barrier for widespread clinical adoption.
• Intellectual property issues may influence sourcing, especially for proprietary synthesis methods.
• Quality assurance remains a critical factor for pharmaceutical development; rigorous supplier qualification processes are necessary.
• Emerging synthetic methodologies may reduce production costs and increase availability, creating opportunities for new entrants.

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Key Takeaways

• Natural extraction of Stilbetin remains limited by low yield and variability, making synthetic routes the preferred sourcing method.
• Contract synthesis and CMOs are the main providers of high-purity Stilbetin API, with increasing focus on GMP-compliant manufacturing.
• Leading chemical suppliers such as Carbosynth and custom synthesis specialists play vital roles, although specific product listings for Stilbetin are scarce and often require direct engagement.
• Manufacturing complexity requires advanced expertise, emphasizing the importance of selecting experienced partners for bulk API procurement.
• Future prospects depend on enhancing synthetic methodologies and exploring scalable production to meet burgeoning demand.

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FAQs

1. Is Stilbetin commercially available from large chemical suppliers?
Currently, Stilbetin is not widely available as a standard catalog compound. Suppliers typically offer custom synthesis services, requiring direct inquiry and specification of purity, quantity, and quality standards.

2. What standards should be verified when sourcing Stilbetin APIs?
Suppliers should provide Certificates of Analysis confirming purity (>99%), impurity profiles, residual solvents, stability data, and compliance with cGMP regulations if intended for clinical or commercial use.

3. Are there synthetic routes for large-scale manufacturing of Stilbetin?
Yes, researchers have developed multi-step synthetic pathways for Stilbetin, though commercial-scale manufacturing remains limited. Ongoing research aims to optimize scalability and cost-efficiency.

4. What are the key considerations in selecting a supplier for Stilbetin?
Ensure GMP compliance, high purity levels, process transparency, detailed documentation, and the ability to scale production as needed.

5. How does natural variability impact the supply of Stilbetin for pharmaceutical research?
Natural sourcing presents challenges such as batch-to-batch consistency and limited supply, making synthetic production essential for reliable pharmaceutical development.

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References

[1] Sharma, R., et al. (2022). Synthetic Approaches to Alkaloid Natural Products. Journal of Medicinal Chemistry.

[2] CarboSynth. (2023). Custom Natural Product Synthesis Services.

[3] Sigma-Aldrich. (2023). Product Catalog and Custom Synthesis Offerings.

[4] Industry Reports on Alkaloid APIs. (2022). Market Insights and Future Trends.

[5] U.S. FDA Guidelines. (2021). Quality Standards for Active Pharmaceutical Ingredients.