Bulk Pharmaceutical API Sources for SODIUM BICARBONATE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for SODIUM BICARBONATE IN PLASTIC CONTAINER

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Bulk Active Pharmaceutical Ingredient (API) Sources for: Sodium Bicarbonate in Plastic Containers

Last updated: August 10, 2025

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Introduction

Sodium bicarbonate, commonly known as baking soda, is a widely used pharmaceutical API with diverse applications, including antacid therapy, urinary alkalization, and as a component in pharmaceutical formulations. Its status as a Generally Recognized as Safe (GRAS) substance underpins its extensive industrial use. This article delineates key bulk suppliers of sodium bicarbonate suitable for pharmaceutical manufacturing, emphasizing sourcing considerations for products intended for packaging in plastic containers. The focus is on reputable manufacturers with quality assurance standards aligned with Good Manufacturing Practice (GMP).

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Overview of Sodium Bicarbonate as a Pharmaceutical API

Sodium bicarbonate (NaHCO₃) is a crystalline powder characterized by high purity, stability, and bioavailability. The API’s pharmaceutical-grade variants demand strict regulation compliance, including USP (United States Pharmacopeia), EP (European Pharmacopoeia), or BP (British Pharmacopoeia) standards. Although primarily available as bulk powder, sourcing in large volumes for encapsulation in plastic packaging demands partnerships with established chemical producers specializing in pharmaceutical excipients and APIs.

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Major Global Suppliers of Pharmaceutical-Grade Sodium Bicarbonate

1. Solvay

Overview: Solvay SAG (Belgium) stands as a leading supplier of pharmaceutical and food-grade sodium bicarbonate. With decades of experience, Solvay offers high-purity, USP-grade sodium bicarbonate suitable for direct use in pharmaceutical formulations.

Key Attributes:

• GMP-certified manufacturing facilities.
• Consistent quality with Certificates of Analysis (CoA).
• Focused on environmentally sustainable processes.
• Custom packaging options, including large bulk packs in plastic containers.

Availability: The product is available in bulk directly from Solvay's pharmaceutical division, with tailored packaging to meet industry needs.

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2. Hexagon Nutrition

Overview: Hexagon Nutrition (India) supplies pharmaceutical-grade sodium bicarbonate globally, catering to pharmaceutical and nutraceutical applications.

Key Attributes:

• ISO and GMP compliant facilities.
• USP and EP standards compliance.
• Large-volume bulk supply, suitable for encapsulation in plastic containers.
• Strong focus on quality assurance.

Availability: Trusted for consistent supply in bulk quantities, with direct logistics to pharmaceutical manufacturing sites.

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3. ICL (Israeli Chemicals)

Overview: ICL Industrial Products is recognized for manufacturing pharmaceutical and food-grade sodium bicarbonate. They operate globally, with multiple manufacturing sites certified to GMP standards.

Key Attributes:

• High-purity pharmaceutical-suitable grades.
• Flexible packaging options, including bulk in plastic drums and containers.
• Strict quality control protocols.

Availability: Offers large-scale supply chains with the capability to deliver sodium bicarbonate in suitable packaging for direct inclusion into pharmaceutical manufacturing lines.

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4. Tosoh Corporation

Overview: Tosoh (Japan) produces pharmaceutical-grade sodium bicarbonate with a focus on purity and safety.

Key Attributes:

• Compliant with international pharmaceutical standards.
• Extensive experience in custom packaging, including bulk supplies.

Availability: Supplies in various container sizes, including bulk options compatible with plastic packaging for pharmaceutical use.

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5. Brenntag

Overview: Brenntag, a global chemical distributor, sources and supplies pharmaceutical-grade sodium bicarbonate through its extensive network.

Key Attributes:

• Access to multiple manufacturers' products.
• Proven quality management systems.
• Distributes in bulk containers suitable for pharmaceutical manufacturing.

Availability: Capable of customizing packaging and logistics based on client needs, ensuring product integrity within plastic containers.

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Sourcing Considerations for Sodium Bicarbonate in Plastic Containers

a. Regulatory Compliance

Purchasing from suppliers holding GMP certification, USP or EP registration, and extensive quality management systems is essential. This ensures that the sodium bicarbonate meets strict international standards for pharmaceutical use.

b. Purity and Quality Assurance

High purity levels (≥ 99%) with low residual impurities are critical. Suppliers should provide comprehensive Certificates of Analysis (CoA), stability data, and batch traceability.

c. Packaging Compatibility and Storage

Plastic containers, such as HDPE drums or bottles, must be compatible with the API to prevent contamination or degradation. Suppliers should ensure container compatibility, seal integrity, and protection against moisture and environmental factors.

d. Delivery and Supply Chain Reliability

Long-term supply agreements with suppliers capable of fulfilling large volume orders while maintaining quality are vital for uninterrupted manufacturing operations.

e. Cost and Logistics

Pricing varies depending on purity, volume, and packaging. Logistics arrangements should prioritize expedited delivery and proper storage conditions.

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Emerging Trends and Best Practices

Sustainable Sourcing: Increasing emphasis on environmentally sustainable manufacturing practices influences supplier selection. Many companies now prioritize suppliers adhering to ISO 14001 standards.

Advanced Packaging Solutions: Use of multilayer, tamper-evident plastic containers with moisture barriers enhances stability and quality assurance.

Digital Quality Monitoring: Suppliers integrating digital tracking and real-time quality control data facilitate transparency and compliance.

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Conclusion

Sodium bicarbonate remains a staple API across multiple pharmaceutical applications, with bulk sourcing becoming increasingly critical as manufacturers scale up operations. Leading global suppliers, including Solvay, Hexagon Nutrition, ICL, Tosoh, and Brenntag, offer pharmaceutical-grade sodium bicarbonate in bulk, adaptable to plastic container packaging. Paramount to selection are strict adherence to regulatory standards, chemical purity, compatibility with plastic packaging, and reliable logistics.

Aligning procurement with these parameters ensures product integrity, regulatory compliance, and production efficiency, critical for pharmaceutical manufacturing success.

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Key Takeaways

• Select GMP-certified suppliers with proven quality assurance and comprehensive regulatory compliance for pharmaceutical sodium bicarbonate.
• Verify container compatibility, especially when sourcing in plastic, to prevent contamination or degradation.
• Prioritize suppliers offering traceable batch data, high purity, and flexibility in packaging options.
• Leverage global suppliers capable of large-volume, sustained supply to support continuous pharmaceutical production.
• Incorporate sustainable sourcing and innovative packaging solutions to future-proof procurement strategies.

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FAQs

1. What standards must pharmaceutical-grade sodium bicarbonate meet for injection into the pharmaceutical supply chain?
Pharmaceutical-grade sodium bicarbonate must meet standards such as USP, EP, or BP, which specify purity (usually ≥ 99%), low residual impurities, and compliance with Good Manufacturing Practice (GMP).

2. Can sodium bicarbonate in plastic containers affect drug stability?
When supplied in appropriately compatible plastic containers, sodium bicarbonate's stability can be maintained. High-density polyethylene (HDPE) is commonly used due to its inertness and barrier properties when properly sealed.

3. Are there regional differences in sodium bicarbonate suppliers?
Yes, regional suppliers like Hexagon Nutrition (India) or Tosoh (Japan) serve local and global markets, often offering competitive pricing and supply chain advantages.

4. How does one verify the authenticity and quality of sodium bicarbonate suppliers?
Verify certifications (GMP, ISO), request product COA, review audit reports, and conduct on-site audits if feasible. Establishing strong supplier relationships ensures product authenticity and quality.

5. What are the key logistical considerations when sourcing sodium bicarbonate bulk in plastic containers?
Consider container sealing integrity, moisture protection, transportation conditions, shelf life, and inventory management to prevent contamination and ensure timely supply.

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References

1. USP-NF. United States Pharmacopeia, Sodium Bicarbonate Monograph, 2023.
2. European Pharmacopoeia. Sodium Bicarbonate Monograph, 2023.
3. Solvay Pharmaceuticals. Product Catalogue, 2023.
4. ICL Industrial Products. Product Data Sheets, 2023.
5. Brenntag Group. Pharmaceutical API Supply Program, 2023.