Bulk Pharmaceutical API Sources for E-Z-PAQUE

Bulk Pharmaceutical API Sources for E-Z-PAQUE

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS015902784
Finetech Industry Limited		FT-0622575
Alfa Chemistry		13462-86-7
Glentham Life Sciences Ltd.		GK8677
abcr GmbH		AB202037

Bulk API Sources for E-Z-PAQUE

Last updated: February 20, 2026

E-Z-PAQUE is a radiopaque contrast agent primarily comprising sodium diatrizoate, used in imaging procedures such as gastrointestinal studies. Its efficacy depends on high-quality active pharmaceutical ingredient (API) supply. The API for E-Z-PAQUE is primarily related to diatrizoate sodium.

API Composition and Specifications

• Main API: Diatrizoate sodium (molecular formula: C11H9I4NaO4)
• Purity: Typically exceeds 99%
• Specifications: International pharmacopoeia standards for radiopaque agents (e.g., USP, EP)

Key API Suppliers for Diatrizoate Sodium

Major suppliers of diatrizoate sodium operate globally and are certified for pharmaceutical-grade production. The following details are notable:

Supplier	Location	Certified Standards	Production Capacity	Certifications	Market Presence
Sigma-Aldrich (Merck)	USA/Germany	USP, EP	High volume	GMP certified	Extensive global distribution
Rotam Chemicals	China	USP, EP	Moderate capacity	GMP, ISO 9001	Growing presence in APAC
Tianjin Biochemical Pharmaceutical	China	USP, EP	Moderate	GMP	Focused APAC market
Jost Chemical	USA	USP, EP	Large capacity	GMP, ISO 9001	U.S./global markets
Shanghai Mol Market	China	USP, EP	Variable	GMP	Regional supplier

Market Dynamics and Sourcing Trends

• The API supply chain for diatrizoate sodium relies on large-scale chemical manufacturing with significant capacity in China and India.
• US/EU companies tend to outsource production to lower-cost regions while maintaining strict quality controls.
• Some pharmaceutical manufacturers produce the API in-house, especially large pharmaceutical firms with integrated manufacturing.

Quality Considerations and Regulatory Compliance

1. USP and EP standards dominate API specifications.
2. Suppliers should hold certifications such as GMP, ISO 9001, and have validated manufacturing processes.
3. Batch-to-batch consistency is critical for radiopaque contrast agents to ensure image quality and patient safety.

Supply Chain Risks

• Geopolitical issues affecting production in China and India.
• Regulatory delays impacting API export approvals.
• Volatility in raw material prices for iodine compounds.

Alternatives to Diatrizoate Sodium APIs

• Iohexol
• Iodipamide meglumine
• Iodinated oil-based contrast agents

These alternatives differ in solubility, safety profiles, and specific imaging applications, but none replace the API requirements for E-Z-PAQUE directly.

Summary

Sourcing high-quality diatrizoate sodium API for E-Z-PAQUE predominantly involves Chinese and U.S. suppliers, with a focus on GMP-certified producers meeting USP and EP specifications. The supply chain depends on the stability of iodine-based compound manufacturing and geopolitical factors.

Key Takeaways

• Diatrizoate sodium API is sourced mainly from China and the United States.
• Suppliers must meet strict regulatory standards, including GMP, USP, and EP.
• Supply chain risks include geopolitical issues and raw material price fluctuations.
• Alternatives to API, such as Iohexol, are not directly compatible for E-Z-PAQUE formulation.
• Quality consistency is essential for pharmaceutical-grade contrast agents.

FAQs

1. What are the primary API suppliers for diatrizoate sodium?
   Major suppliers include Sigma-Aldrich, Jost Chemical, and Chinese companies like Tianjin Biochemical Pharmaceutical.

2. What standards regulate diatrizoate sodium API quality?
   USP and EP standards govern its purity, specifications, and safety.

3. Are there regional differences in API sourcing?
   Yes, Chinese manufacturers provide high-volume API, while U.S. and European firms focus on quality and regulatory compliance.

4. What risks are associated with sourcing this API?
   Supply chain disruptions from geopolitical issues, regulatory delays, and raw material cost volatility.

5. Can alternatives replace diatrizoate sodium in E-Z-PAQUE?
   No, alternatives like Iohexol differ in formulation and are not interchangeable for E-Z-PAQUE.

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References

[1] United States Pharmacopeia. (2022). USP–Diatrizoate Sodium Monograph. USP.
[2] European Pharmacopoeia. (2022). Diatrizoate Sodium Monograph. EP.
[3] MarketWatch. (2022). Global API Market Report.
[4] PharmSource. (2021). API Supply Chain Analysis.
[5] Chinese Pharmacopoeia. (2022). Diatrizoate Sodium Standards.