Bulk Pharmaceutical API Sources for CUPRIC CHLORIDE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CUPRIC CHLORIDE IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		203149_ALDRICH
Sigma-Aldrich		222011_ALDRICH
Sigma-Aldrich		451665_ALDRICH
AKos Consulting & Solutions		AKOS015902778
BroadPharm		BP-13443
Oakwood Products		075005

Bulk Active Pharmaceutical Ingredient (API) Sources for: CUPRIC CHLORIDE IN PLASTIC CONTAINER

Last updated: July 27, 2025

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Introduction

Cupric chloride (CuCl₂) serves as a versatile chemical with applications spanning pharmaceuticals, agrochemicals, and industrial processes. In pharmaceutical manufacturing, its use as a reagent or additive necessitates sourcing high-quality bulk APIs. When supplied in plastic containers, concerns around chemical stability, contamination, and regulatory compliance become paramount. This article explores the prominent global sources of bulk cupric chloride APIs, the considerations for procurement in plastic containers, and industry best practices to ensure quality and safety.

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Overview of Cupric Chloride (CuCl₂)

Cupric chloride is a soluble copper salt, typically available in anhydrous or hydrate forms. Its applications include auxiliary roles in pharmaceutical synthesis, diagnostic assays, and chemical research. The quality parameters for pharmaceutical-grade cupric chloride include high purity (usually ≥99%), low residual impurities, and compliance with pharmacopoeial standards such as USP, EP, or JP.

The supply of CuCl₂ in plastic containers offers benefits—cost-effectiveness, ease of handling, and compatibility with certain storage conditions. However, stability considerations necessitate careful choice of container material and supplier.

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Global Sources of API for Cupric Chloride in Bulk

1. Asia-Pacific Region

a. China

China remains the dominant producer and exporter of chemical reagents, including cupric chloride. Leading companies like Yantai Dongcheng Chemical Co., Ltd. and Shandong Jinbao Chemical Co., Ltd. manufacture pharmaceutical-grade CuCl₂. These suppliers typically offer bulk quantities and have the infrastructure to produce in compliance with GMP standards.

Advantages: Competitive pricing, high-volume availability, extensive manufacturing capacity.
Considerations: Require verification of GMP certification, purity specifications, and export documentation for pharmaceutical applications.

b. India

India-based manufacturers such as Anand Agro Chemicals and Aarti Industries manufacture high-quality cupric chloride, often adhering to pharmacopeial standards. India’s API industry benefits from strong regulatory oversight and a growing focus on quality assurance.

Advantages: Secure supply, compliance with international standards, reliable documentation.
Considerations: Potential lead times, export restrictions, and detailed due diligence needed on supplier GMP compliance.

2. Europe

European producers like Merck KGaA and Sigma-Aldrich (a part of MilliporeSigma) supply pharmaceutical-grade cupric chloride, including in plastic containers for research and industrial use. European suppliers prioritize high purity, stringent quality management, and regulatory compliance.

Advantages: High quality standards, certifications, consistent supply.
Considerations: Higher price point compared to Asian suppliers; procurement may involve lengthy validation procedures.

3. North America

In North America, COPPERCHEM and VWR International offer APIs including cupric chloride, often tailored for pharmaceutical and analytical purposes. These suppliers focus on purity, quality control, and compliance with FDA regulations.

Advantages: Quality assurance, regulatory familiarity, robust supply chains.
Considerations: Cost and minimum order quantities.

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Standards and Certification for API Sources

Suppliers must meet stringent pharmaceutical standards:

• GMP Certification: Ensures manufacturing consistency, cleanliness, and quality controls.
• Pharmacopoeial Compliance: USP, EP, JP specifications for purity, residual solvents, and impurities.
• Material Safety Data Sheets (MSDS): For handling, storage, and safety protocols.

Additional certifications such as ISO 9001 or ISO 13485 (for medical devices) further substantiate quality claims.

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Considerations for Shipping and Storage in Plastic Containers

Container Compatibility

Cupric chloride solutions are typically stored in HDPE (High-Density Polyethylene) or other inert plastics to prevent corrosion or leaching. Plastic containers must be opaque or UV-resistant to prevent photodegradation.

Chemical Stability

Cupric chloride's stability depends on storage conditions—cool, dry, and shielded from light. If supplied in plastic bottles, suppliers often incorporate anti-UV or barrier layers. It is crucial to verify chemical compatibility and stability data before procurement.

Regulatory Compliance

Packaging must meet pharmaceutical safety standards, with appropriate labeling, tamper-evidence, and documentation. Plastic containers should be validated for API compatibility and stability over the intended shelf life.

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Quality Assurance and Due Diligence

Prior to sourcing cupric chloride in bulk for pharmaceutical use:

• Request Certificates of Analysis (CoA): Confirm purity levels, residual solvents, and impurity profile.
• Conduct On-site Audits or Supplier Qualification: Ensures adherence to GMP and quality management systems.
• Sample Testing: Independent laboratory analysis to validate supplier claims.
• Traceability: Maintain comprehensive documentation for batch history and regulatory audits.

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Key Players in the API Market for Cupric Chloride in Plastic Containers

Supplier	Region	Certifications	Notes
Yantai Dongcheng Chemical	China	GMP, ISO	Large-scale producer, competitive pricing
Shandong Jinbao Chemical	China	GMP, ISO	Focused on pharmaceutical-grade APIs
Merck KGaA	Europe	GMP, EP, USP	Premium quality, reliable supply chain
Sigma-Aldrich	Europe/NA	GMP, ISO	Extensive catalog, quality assurance
VWR International	NA	GMP, ISO	Custom packaging options including plastics

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Regulatory and Compliance Landscape

Sourcing from certified suppliers is critical for regulatory compliance. International agencies, such as the FDA and EMA, require validated suppliers with proven GMP adherence. Import/export documentation, qualification protocols, and stability data are mandatory to ensure API integrity in plastic containers during storage and transport.

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Conclusion

The choice of bulk cupric chloride API sources hinges on purity, regulatory compliance, supply reliability, and storage conditions. Asian suppliers provide cost-effective, high-volume options, while European and North American providers prioritize stringent quality standards. When storing in plastic containers, adherence to compatibility and stability parameters is essential to maintain API quality.

Sourcing from certified vendors with comprehensive documentation and quality control measures ensures pharmaceutical manufacturers meet regulatory requirements and safeguard product integrity.

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Key Takeaways

• Global sourcing options include China, India, Europe, and North America, each with distinct advantages regarding cost, quality, and supply assurance.
• High purity standards (≥99%) and compliance with pharmacopoeial specifications are non-negotiable for pharmaceutical applications.
• Plastic container compatibility varies; HDPE or inert plastics are preferred, with validation of stability and leaching parameters.
• Vetting suppliers through audits, certifications, and independent testing mitigates risks of contamination and regulatory non-compliance.
• Regulatory adherence is essential; ensure documentation, stability data, and GMP certification accompany all supply transactions.

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FAQs

1. What factors should I consider when selecting a supplier for cupric chloride API?
   Ensure GMP certification, pharmacopoeial compliance, consistent purity, transparent documentation, and proven supply reliability.

2. Is cupric chloride stable in plastic containers over time?
   Yes, when stored under appropriate conditions—cool, dry, protected from light—cupric chloride remains stable in inert plastics like HDPE, provided compatibility and stability data support its use.

3. What safety measures are necessary when handling bulk cupric chloride?
   Use appropriate PPE (gloves, goggles, lab coat), handle in well-ventilated areas, and follow MSDS guidelines for safe storage and disposal.

4. How do regulatory agencies verify API quality in pharmaceutical manufacturing?
   Through supplier audits, batch certification, validated analytical testing, and strict documentation aligned with GMP standards.

5. Are there specific challenges associated with sourcing cupric chloride in bulk for pharmaceutical use?
   Challenges include ensuring purity, verifying supplier compliance, maintaining chemical stability during shipping, and adherence to evolving regulations.

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References

[1] United States Pharmacopeia (USP). Cupric Chloride Monograph.
[2] European Pharmacopoeia (EP). Copper Chloride Monograph.
[3] Sigma-Aldrich Product Documentation. Cupric Chloride, High Purity.
[4] World Health Organization. Guidelines on Quality Assurance of Pharmaceuticals.
[5] Industry Reports on API Manufacturing and Supply Chain Management.