LIQUID E-Z-PAQUE bulk active fine chemical sources

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Last updated: August 5, 2025

Introduction

Liquid E-Z-PAQUE is a contrast agent typically used in medical imaging procedures such as fluoroscopy, computed tomography (CT), and other radiographic applications. Its efficacy hinges on integral Active Pharmaceutical Ingredients (APIs) that provide high radiodensity, stability, and biocompatibility. Identifying reliable bulk API sources is critical for pharmaceutical manufacturers aiming to produce high-quality, compliant contrast agents. This article explores the landscape of API suppliers applicable to Liquid E-Z-PAQUE, emphasizing procurement strategies, quality standards, and market dynamics.

Understanding the API Composition of Liquid E-Z-PAQUE

The core API responsible for the radiopacity in Liquid E-Z-PAQUE is Barium Sulfate or Barium-based compounds. Barium sulfate (BaSO4) is the preferred radiocontrast agent owing to its insolubility, excellent radiodensity, and safety profile when administered correctly. It functions as a high-density agent that enhances the visibility of gastrointestinal tract, blood vessels, and other internal structures during imaging.

Other ingredients, such as stabilizers, preservatives, or excipients, may complement the API but are typically considered inactive ingredients. For our scope, the focus remains on bulk Barium Sulfate sources.

Global API Suppliers for Barium Sulfate

1. Major International Manufacturers

The global industry hosts several prominent manufacturers of pharmaceutical-grade Barium Sulfate, recognized for complying with pharmacopeial standards such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia). These suppliers cater to both OEM and generic manufacturing firms producing Liquid E-Z-PAQUE or similar contrast agents.

E. I. du Pont de Nemours and Company (DuPont)
Historically one of the early producers of Barium Sulfate, DuPont supplies high-purity grades suitable for medical applications. Their offerings are characterized by consistent particle size distribution and low impurity profiles.
Thermo Fisher Scientific
A leader in specialized chemicals, Thermo Fisher's Barium Sulfate complies with medical-grade standards, supporting various radiology applications. Their global distribution network facilitates ease of procurement.
Brugnatelli Group
An established European supplier specializing in inorganic pharmaceutical-grade powders, including Barium Sulfate. Known for high purity and adherence to European regulatory standards.
Matsuno Chemical (Japan)
A notable manufacturer providing Barium Sulfate with strict quality control, suitable for international pharmaceutical manufacturing.
American Elements
Offers high-purity Barium Sulfate powders, meeting various pharmacopeial specifications, with a focus on research-grade and pharmaceutical-grade materials.

2. Asian Suppliers

Asia remains a significant hub for bulk pharmaceutical ingredients, offering cost-effective, high-quality Barium Sulfate:

Hong Kong X-MAX Chemical Co., Ltd.
Supplies pharmaceutical-grade Barium Sulfate with validated purity profiles, supporting regional manufacturing.
Shandong Taihe Pharmaceutical Co., Ltd.
Focuses on high-quality inorganic powders, including Barium Sulfate, with compliance to international standards.
Nantong Sinocat Anti-Corrosive Coatings Co., Ltd.
Provides specialized Barium Sulfate grades for medical and industrial applications.

3. Domestic (U.S. and European) Suppliers

Locally sourced APIs often simplify regulatory compliance and logistics:

Suppliers like American Elements and Sigma-Aldrich (MilliporeSigma) provide certified pharmaceutical Barium Sulfate powders, ensuring traceability and batch consistency.

Key Considerations for API Sourcing

Regulatory Compliance: Ensuring API vendors adhere to cGMP standards and possess relevant certifications such as FDA approval, ISO certifications, and pharmacopeial compliance.
Particle Size and Purity: APIs for contrast agents require specific particle size distributions (often sub-micron to micron scale) and minimal impurities that may affect safety or imaging quality.
Supply Chain Stability: Reliable suppliers with proven production capacity and contingency planning mitigate risk of shortages.
Cost and Lead Time: Competitive pricing must be balanced with quality standards to ensure profitability and meet production schedules.
Customization and Packaging: Suppliers capable of providing tailored particle sizes and appropriate packaging (bulk drums, containers) facilitate seamless manufacturing processes.

Emerging Trends and Market Dynamics

The increasing demand for high-quality contrast agents propels innovation in API manufacturing:

Nanoparticle Barium Sulfate: Ongoing research explores nano-sized particles for enhanced imaging efficacy and reduced adverse effects, with APIs supplied by specialized nano-material producers.
Alternative Barium Compounds: Though BaSO4 remains dominant, some research centers explore innovative formulations to improve biocompatibility or absorption profiles, influencing API sourcing strategies.
Regulatory Disruptions: Emerging regulations emphasize traceability and sustainability, prompting manufacturers to prefer API suppliers with robust compliance records and environmental management practices.

Quality Assurance and Regulatory Pathways

All API sources for Liquid E-Z-PAQUE must conform to strict quality standards. International pharmacopeias specify requirements for Barium Sulfate used in parenteral and enteral applications. Vendors should provide:

Batch-specific Certificates of Analysis (CoA)
Particle size and morphology data
Purity and residual impurity profiles
Validation of sterilization processes where applicable

Establishing long-term supplier relationships with rigorous qualification audits reduces variability and ensures regulatory compliance with agencies such as the FDA, EMA, and PMDA.

Conclusion

Sourcing high-quality, compliant Barium Sulfate APIs remains fundamental for the production of effective Liquid E-Z-PAQUE contrast agents. Leading international suppliers like DuPont, Thermo Fisher, and regional Asian manufacturers offer a diverse array of pharmaceutical-grade APIs tailored to meet stringent medical standards. Strategic acquisition—considering regulatory compliance, quality, reliability, and cost—is vital for maintaining market competitiveness and ensuring patient safety.

Key Takeaways

Primary API Source: Barium Sulfate remains the essential API for Liquid E-Z-PAQUE, with high purity and appropriate particle size being critical parameters.
Global Supply Chain: Major suppliers encompass North American, European, and Asian firms, each with varying certifications and capabilities.
Regulatory & Quality Compliance: Ensuring API suppliers meet pharmacopeial and regulatory standards minimizes risks associated with manufacturing and approval.
Emerging Technologies: Nano-sized Barium Sulfate and alternative formulations are on the horizon, potentially influencing future API sourcing strategies.
Supplier Qualification: Long-term partnerships backed by rigorous quality assessments streamline manufacturing and compliance processes.

Frequently Asked Questions (FAQs)

1. What are the key regulatory requirements for sourcing API for Liquid E-Z-PAQUE?
APIs must comply with pharmacopeial standards (USP, EP, JP) and obtain necessary certifications such as cGMP compliance, FDA approval, and batch-specific CoAs to ensure safety, purity, and efficacy.

2. How does particle size influence API selection for contrast agents?
Particle size directly impacts radiopacity and stability; smaller particles offer better dispersion and imaging quality but require precise manufacturing controls to prevent aggregation or toxicity.

3. Are there alternatives to Barium Sulfate as an API in contrast agents?
Alternatives such as iodine-based compounds exist; however, Barium Sulfate’s insolubility and favorable safety profile favor its continued dominance in gastrointestinal imaging contrast agents.

4. What are the risks associated with uncertified API sources?
Using non-compliant or uncertified APIs can lead to regulatory issuance, subpar imaging results, safety concerns like toxicity or allergic reactions, and batch variability.

5. How can manufacturers ensure supply chain resilience for API procurement?
Developing relationships with multiple certified suppliers, maintaining adequate inventory levels, and conducting regular audits mitigate supply disruptions.

References

[1] United States Pharmacopeia. Barium Sulfate monograph. USP, 2022.
[2] European Pharmacopoeia. Barium Sulfate detailed specifications. EP, 2021.
[3] Global Pharmaceutical Raw Materials Report. Market Dynamics of Barium Compounds, 2022.
[4] Regulatory Guidelines for Contrast Media. FDA, 2023.
[5] Nano-Particle Technologies in Medical Imaging. Journal of Radiology, 2022.

Disclaimer: This article is intended for informational purposes and does not constitute an endorsement of any supplier or product. Always conduct due diligence aligned with your regulatory and manufacturing requirements.

Bulk Pharmaceutical API Sources for LIQUID E-Z-PAQUE