Bulk Pharmaceutical API Sources for isoflurophate

Bulk Pharmaceutical API Sources for isoflurophate

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ChemExper Chemical Directory		HmTLPDp`|HdLddJTTfjj`@@
Sigma-Aldrich		D0879_SIGMA
Calbiochem		30967

Bulk Active Pharmaceutical Ingredient (API) Sources for ISOFLUROPHATE

Last updated: July 30, 2025

Introduction

Isoflurophate, a potent cholinesterase inhibitor primarily used in ophthalmology, is recognized for its application in research and certain therapeutic contexts. This organophosphorus compound exerts its activity by irreversibly inhibiting acetylcholinesterase, providing utility in diagnostics and experimental treatments related to cholinergic functioning. Due to its potent bioactivity and potential misuse, sourcing high-quality bulk APIs like isoflurophate involves navigating a complex landscape of regulatory restrictions, supplier credibility, and regional availability. This article offers an in-depth analysis of global suppliers, regulatory considerations, and strategic sourcing approaches pertinent to pharmaceutical manufacturers, research institutions, and regulatory bodies.

Regulatory Context and Considerations

Isoflurophate's classification as a neurotoxin and organophosphorus compound categorizes it under stringent controls within most jurisdictions. In the United States, the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) regulate its manufacture, distribution, and use, mainly given its potential toxicity and misuse for chemical weapon production [1]. Similar regulations exist across the European Union, China, and other regions, mandating proper licensing, tracking, and compliance with international treaties like the Chemical Weapons Convention (CWC) administered by the OPCW [2].

Competent sourcing requires verifying supplier adherence to Good Manufacturing Practices (GMP), proper documentation, and Certificates of Analysis (CoA). Raw material security, purity standards (typically exceeding 99%), and batch consistency are non-negotiable for pharmaceutical-grade APIs. Companies must also consider import/export restrictions, potential licensing, and security measures when sourcing isoflurophate.

Major Global API Suppliers for Isoflurophate

1. Established Chemical and Pharmaceutical API Manufacturers

Leading chemical manufacturers with expertise in organophosphorus compounds include:

• Sigma-Aldrich (MilliporeSigma): A prominent supplier known for a broad portfolio of research-grade chemicals, including various organophosphates. They provide high-purity isoflurophate suitable for laboratory use, with comprehensive CoA documentation [3].

• Tci Chemicals: Offers research-grade isoflurophate, primarily targeting scientific research and instrumentation laboratories. Their global network ensures availability but often emphasizes non-GMP grade materials [4].

• Santa Cruz Biotechnology: Provides analytical-grade isoflurophate for research purposes, with a focus on the North American market. Their supply chain emphasizes quality control and regulatory compliance.

2. Specialized Organophosphorus Chemical Producers

Few manufacturers specialize specifically in organophosphates like isoflurophate due to regulatory hurdles. However, some niche chemical producers in Asia and Europe have capabilities:

• Jubilant Life Sciences: Known for their chemical syntheses, including specialty organophosphates, primarily for industrial and research applications. They hold certifications that support export, though specific APIs require confirmation.

• Shenzhen Esco Chemical Co., Ltd.: Engages in manufacturing chemical intermediates and specialty compounds, including organophosphates, primarily for research purposes.

3. Contract Manufacturing Organizations (CMOs)

Certain CMOs offer synthesis and custom manufacturing of organophosphorus compounds:

• Bachem: While primarily focused on peptides and biologics, some collaboration projects may include synthesis of specialized compounds like isoflurophate, especially for research.

• Auriga Chemicals: Provides custom synthesis of organophosphates, adhering to customer specifications, and can produce GMP-grade APIs for clinical development.

4. Emerging Markets and Local Suppliers

Developing regions often have local chemical producers capable of synthesizing isoflurophate. Yet, due diligence regarding quality and regulatory compliance is critical. Regulatory authorities such as China's NMPA (National Medical Products Administration) and India's CDSCO oversee licensing and quality standards that suppliers must meet.

Strategic Sourcing Considerations

• Quality Assurance: Prioritize suppliers with audited GMP facilities, robust quality management systems, and transparent documentation. Confirm specific purity certifications and batch reproducibility.

• Regulatory Compliance: Confirm that APIs conform to regional regulations, especially regarding controlled substances classification, import/export licenses, and CWC adherence.

• Supplier Reliability: Evaluate supplier reputation, delivery capacity, technical support, and flexibility in batch sizing, especially given the often limited commercial demand.

• Pricing and Lead Times: Balance cost considerations with regulatory and quality assurance requirements, factoring in potential delays due to licensing or customs clearance.

• Security and Confidentiality: Maintain strict confidentiality, given the dual-use concerns associated with nerve agents and organophosphates.

Supply Chain Challenges and Risk Mitigation

Sourcing isoflurophate entails dealing with:

• Regulatory Restrictions: Stringent controls increase procurement complexities.

• Limited Commercial Suppliers: Few manufacturers produce this specialized API commercially.

• Traceability and Documentation: Ensuring traceability from synthesis to delivery to affirm quality and compliance.

• Potential for Diversification: Employ multiple suppliers within legal frameworks to mitigate supply disruption risks.

• Advanced Planning: Secure supply agreements well ahead of project timelines, particularly when sourcing from regions with variable export policies.

Conclusion

Accessing high-quality bulk isoflurophate requires strategic navigation of a niche but critical pharmaceutical supply landscape. Ensuring compliance with regulatory frameworks, verifying supplier reliability, and adhering to security protocols are essential. The market offers a limited number of established suppliers, with research-focused grade APIs readily available from major chemical suppliers. However, for GMP-grade material, partnerships with specialized CMOs and licensed chemical manufacturers are prudent. Maintaining a proactive, compliant, and security-conscious approach enables stakeholders to leverage isoflurophate effectively for research and limited therapeutic applications.

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Key Takeaways

• Isoflurophate is a highly regulated organophosphorus compound used mainly for research and diagnostic purposes.

• Reliable sourcing depends heavily on complying with international and regional regulatory frameworks, including CWC and local drug authorities.

• Major suppliers include Sigma-Aldrich, Tci Chemicals, and specialized chemical contractors capable of GMP-grade production.

• Due diligence—covering quality, documentation, licensing, and security—is essential when sourcing isoflurophate.

• Strategic diversification and advanced procurement planning mitigate risks associated with restricted supply chains and regulatory hurdles.

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FAQs

1. Is isoflurophate legally available for commercial purchase?
Due to its classification as a neurotoxin and potential chemical weapon precursor, isoflurophate's sale is highly restricted and typically limited to licensed entities engaged in research, diagnostics, or approved medical applications under strict regulatory oversight.

2. What are the primary regulations governing the import and export of isoflurophate?
Regulations vary by jurisdiction but generally include compliance with the Chemical Weapons Convention (CWC), U.S. DEA controls, and regional chemical safety laws. Export licenses, import permits, and end-user certifications are often mandatory.

3. How can companies ensure the quality of bulk isoflurophate from suppliers?
Request comprehensive Certificates of Analysis, verify supplier GMP certifications, perform third-party testing when necessary, and ensure adherence to relevant pharmacopeial standards.

4. Are there alternatives to isoflurophate for research purposes?
While alternatives may exist for some applications, no substitute perfectly replicates its specific cholinesterase inhibitory activity. Researchers often use analogs or other organophosphates, subject to regulatory approval and compatibility.

5. What are the key risks associated with sourcing isoflurophate?
Risks include regulatory non-compliance, supply disruptions, security concerns related to misuse, and purity variability. Proper licensing, security protocols, and supplier audits mitigate these risks.

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References

[1] U.S. Drug Enforcement Administration. (2022). Controlled Substance Act Regulations.
[2] OPCW. (2021). Chemical Weapons Convention regulations and compliance guidelines.
[3] Sigma-Aldrich. Product datasheet and quality standards.
[4] Tci Chemicals. Company profile and product catalog.