Bulk Pharmaceutical API Sources for diethylstilbestrol

Bulk Pharmaceutical API Sources for diethylstilbestrol

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		218944_ALDRICH
Sigma-Aldrich		D4628_SIGMA
Vitas-M Laboratory		STK366318
TCI (Tokyo Chemical Industry)		D0526
Molport		MolPort-001-785-868

Bulk Active Pharmaceutical Ingredient (API) Sources for: Diethylstilbestrol

Last updated: July 30, 2025

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Introduction

Diethylstilbestrol (DES) is a potent synthetic non-steroidal estrogen historically used for various medical indications, including hormone replacement therapy and the prevention of miscarriages. Despite its withdrawal from many markets due to safety concerns, DES remains relevant in research, forensic analysis, and pharmaceutical manufacturing, necessitating reliable bulk API sources. This analysis explores the current landscape of bulk DES suppliers, focusing on manufacturer capabilities, regulatory status, quality assurance, and market dynamics.

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Overview of Diethylstilbestrol (DES)

Developed in the 1930s, DES gained widespread use in the mid-20th century. However, adverse effects, including carcinogenicity and reproductive health issues, prompted regulatory bans or restrictions in numerous countries. Today, DES is classified as a controlled substance or requires special manufacturing and handling protocols in jurisdictions where its use persists, primarily for research or compounding purposes.

The chemical structure of DES (C18H20O2) classifies it among non-steroidal estrogenic compounds, synthesized via aldol condensation and subsequent purification steps. The API's quality is critical, given its potent biological activity and the regulatory scrutiny surrounding its manufacturing.

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Global API Manufacturing Landscape

1. Major API Manufacturers and Suppliers

The primary sources for bulk DES API are limited, reflecting its restricted clinical use and regulatory status. Many reputable API manufacturers operate in regions with well-established pharmaceutical industries, such as Europe, North America, and Asia.

• Biosynth Carbosynth: A leading supplier of custom and catalog APIs, including estrogenic compounds. They offer high-grade DES suitable for research and analytical purposes conforming to pharmacopeial standards. Biosynth's quality assurance protocols align with GMP requirements, suitable for research-grade applications.

• Toronto Research Chemicals (TRC): Known for a comprehensive catalog of research chemicals, TRC supplies high-purity DES powders validated for laboratory use. While TRC products generally cater to research purposes, their manufacturing processes adhere to high standards, ensuring consistency.

• Steraloids Inc.: Specializes in hormones and steroid-related APIs, including DES, primarily for research and analytical laboratories. Their products meet rigorous purity specifications and are supplied with detailed Certificates of Analysis (CoA).

• Sigma-Aldrich / MilliporeSigma: As a global chemical supplier, Sigma offers DES as a research chemical, often in powdered form. Their API is typically suitable for research and analytical workflows, with strict quality documentation.

• Cayman Chemical: Focuses on life science research chemicals, including DES. They supply high-purity APIs compatible with rigorous research protocols.

2. Regional API Suppliers

In China and India, several manufacturers produce DES API, primarily for export and research markets:

• SinoPharm: A Chinese pharmaceutical and chemical manufacturer supplying research-grade DES. Many Chinese manufacturers, like SinoPharm, produce APIs following local GMP standards and export compliant materials.

• Hubei Sanonda: A producer of steroid derivatives, extending to DES, primarily for research use in Asian markets.

• Sun Pharmaceutical Industries: Though primarily a finished pharmaceutical company, some subsidiaries or partner entities in India may produce DES for research applications.

Note: Due to the banned or restricted status of DES in medicinal formulations in many jurisdictions, it is seldom produced for therapeutic use outside research contexts. Correspondingly, many manufacturers market DES strictly for laboratory or analytical purposes.

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Regulatory and Quality Considerations

Most bulk DES APIs are supplied as research chemicals rather than pharmaceutical-grade APIs intended for human administration. Consequently, their regulatory status varies:

• GMP Compliance: Few suppliers maintain full GMP manufacturing for DES, emphasizing research-grade quality.

• Certifications: Suppliers usually provide Certificates of Analysis (CoA), detailing purity levels (often >98%), residual solvents, and heavy metals.

• Legal Restrictions: Some jurisdictions categorize DES as a controlled precursor owing to its hormonal activity, necessitating import/export licenses or specific licensing arrangements.

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Market Dynamics and Trends

• Demand Drivers: The primary market for bulk DES API comprises research institutions, forensic laboratories, and analytical chemists.

• Supply Constraints: Due to safety concerns and regulatory restrictions, production remains limited, with most suppliers maintaining stock for research purposes rather than therapeutic supply.

• Emerging Sources: Increased scrutiny has led to increased verification of suppliers. Some unregulated or illicit sources occasionally flood the market with poorly characterized or substandard DES.

• Counterfeit Risks: Given the compound's potency and restrictions, counterfeit or adulterated APIs pose significant risks. Business partners must verify supplier accreditation, GMP compliance, and product integrity.

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Emerging Alternatives and Future Outlook

Although DES’s clinical use declined sharply, ongoing research into estrogen receptor ligands and endocrine disruptors sustains a niche demand for high-quality DES API. Suppliers are focusing on ensuring compliance with evolving regulatory standards, with an emphasis on purity, traceability, and documentation.

Regulatory agencies, including the FDA, EMA, and PMDA, continue to enforce strict controls on hormonal APIs, nudging suppliers toward transparency and quality assurance. The continued presence of licensed API sources signifies ongoing, albeit niche, demand within research sectors.

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Conclusion and Recommendations

The procurement of bulk DES API is primarily driven by research and analytical application requirements. Reputable suppliers such as Biosynth Carbosynth, TRC, Steraloids, Sigma-Aldrich, and Cayman Chemical offer high-purity, well-documented DES suitable for scientific purposes. Buyers should prioritize verified, GMP-compliant sources to ensure product integrity, especially given the compound's legal and safety considerations.

For pharmaceutical companies or institutions seeking bulk DES, rigorous due diligence regarding supplier credentials, regulatory compliance, and quality documentation is essential. Given the restricted therapeutic use, it is unlikely that large-scale production exists outside research contexts. Importantly, compliance with regional regulatory frameworks governing hormonal substances remains a mandatory facet of procurement and handling.

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Key Takeaways

• Major suppliers of bulk diethylstilbestrol API include Biosynth Carbosynth, TRC, Steraloids, Sigma-Aldrich, and Cayman Chemical, mostly providing research-grade materials.

• Due to safety and regulatory restrictions, DES is primarily available for research, analytical, and forensic applications, not therapeutic use.

• Quality assurance is critical; buyers should verify certificates of analysis and supplier credentials, emphasizing GMP compliance where applicable.

• Regulatory restrictions and legal considerations must be thoroughly assessed before procurement, especially in jurisdictions with strict controls on hormonal compounds.

• The market for bulk DES is niche and limited, with increasing emphasis on supplier verification and product authenticity.

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FAQs

1. Is Diethylstilbestrol still available for pharmaceutical manufacturing?
Limited to no. Due to safety concerns and regulatory bans, DES is generally not available for therapeutic production but remains accessible for research and analytical purposes.

2. What are the primary regions supplying bulk DES API?
North America (via companies like Steraloids, Sigma-Aldrich), Europe (Biosynth Carbosynth), and Asia (Chinese and Indian manufacturers) are key sources, mostly providing research-grade materials.

3. What quality standards should buyers expect from suppliers?
Certificates of Analysis confirming high purity (>98%), residual solvent levels, heavy metal testing, and adherence to regulatory standards such as GMP or ISO accreditation.

4. Are there legal restrictions associated with importing DES API?
Yes. Many countries regulate hormonal substances, requiring import licenses, proper documentation, and adherence to controlled substance regulations.

5. Can I acquire DES API directly from manufacturers or only through intermediaries?
Reputable manufacturers typically sell directly to validated buyers, especially research institutions, but may also engage with authorized distributors.

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References

1. [1] Biosynth Carbosynth. "Active Pharmaceutical Ingredients," biosynth.com.
2. [2] Toronto Research Chemicals. "Research Chemicals Catalog," trc-inc.com.
3. [3] Steraloids Inc. "Hormone and Steroid API Profiles," steraloids.com.
4. [4] Sigma-Aldrich. "Chemical Product Listings," sigmaaldrich.com.
5. [5] Regulatory considerations for hormonal APIs in global markets, International Pharmaceutical Regulators Forum, 2022.

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Disclaimer: The information herein serves informational and research purposes only. Procurement and handling of DES should comply with applicable laws and regulations, and professional legal advice is recommended.