SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER bulk active fine chemical sources

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Last updated: August 8, 2025

Introduction

Sodium lactate, a widely used pharmaceutical excipient and active ingredient, is often supplied in various concentrations and packaging forms for clinical and manufacturing applications. Specifically, a 0.167 molar solution of sodium lactate stored in plastic containers represents a common formulation for parenteral fluids, nutritional supplements, and topical applications. Ensuring reliable, high-quality API sourcing is critical for pharmaceutical firms seeking consistent product performance and regulatory compliance.

This report comprehensively examines the global landscape of API suppliers for sodium lactate at the specified concentration and packaging, emphasizing supply chain dynamics, quality standards, regulatory considerations, and key market players.

Understanding Sodium Lactate and Its Pharmaceutical Uses

Sodium lactate, the sodium salt of lactic acid, plays a multifaceted role in pharmaceuticals:

Electrolyte replenishment in intravenous fluids.
pH buffer in drug formulations.
Moisturizer and humectant in topical formulations.
Metabolic aid in neonatal and surgical care.

The 0.167 molar concentration approximates a 1.0% solution, aligning with typical physiological and clinical use cases. Packaging in plastic containers (usually polyethylene or polypropylene) facilitates ease of handling, stability, and sterilization compatibility.

Global API Suppliers for Sodium Lactate 0.167 M in Plastic Containers

1. Leading Manufacturers and Suppliers

a) Fresenius Kabi

Renowned for sterile injectable solutions and pharmaceutical excipients.
Supplies sodium lactate solutions globally, including in pre-filled or bulk plastic containers.
Known for strict adherence to USP, EP, and JP standards, with global distribution channels.

b) Baxter International

Offers sodium lactate solutions primarily aimed at infusion therapies.
Sources include high-quality manufacturing plants compliant with cGMP and ISO certifications.

c) Roquette Frères

A key producer of pharmaceutical and nutritional ingredients.
Supplies sodium lactate solutions suitable for clinical and manufacturing purposes, often in flexible plastic containers.

d) Cargill

Provides food-grade and pharmaceutical-grade sodium lactate.
Operates manufacturing facilities with extensive capacity and regulatory compliance for global distribution.

e) Hebei Shuanghe Pharmaceutical Co., Ltd.

A major Chinese supplier of sodium lactate solutions, including pharmaceutical-grade products.
Offers scalable production with strict quality controls.

f) National Formulary and Industry-Specific Producers

Several regional and local manufacturers offer sodium lactate solutions, particularly in Asia, Europe, and North America.
Quality standards vary, but many comply with international pharmacopeias.

2. Sourcing Considerations

Regulatory Compliance: Suppliers must meet standards dictated by USP, EP, JP, or other pharmacopeias.
Quality Certifications: ISO 9001, cGMP, and FDA approval are critical indicators.
Product Specifics: Concentration, sterility, pH, and container material (plastic) are essential parameters.
Packaging: Plastic containers typically range from 100 mL to several liters—availability of a 0.167 M solution in specified containers must be verified directly.

Supply Chain Dynamics and Market Trends

The global demand for sodium lactate solutions, especially in clinical settings, has surged due to increased healthcare needs, growth in IV therapy, and the expansion of nutritional and pharmaceutical markets. Supply chain disruptions, notably during the COVID-19 pandemic, highlighted the importance of diversifying sources and securing supply agreements.

Manufacturers increasingly focus on:

Scaling production for high-demand pharmaceutical-grade solutions.
Ensuring traceability and documentation.
Developing regional manufacturing hubs to mitigate logistical challenges.

In addition, biosimilar and generics markets have driven demand for high-quality, cost-effective API sources.

Regulatory and Quality Standards

When sourcing sodium lactate solutions, particularly for injectable or clinical use, adherence to strict quality standards is non-negotiable:

USP (United States Pharmacopeia) standards for pharmaceutical excipients.
EP (European Pharmacopoeia) compliance.
JP (Japanese Pharmacopoeia) standards for regional markets.

Manufacturers must provide Batch Certification, Certificates of Analysis (CoA), and stability data confirming solution sterility, pH, osmolarity, and absence of contaminants.

Key Factors in Selecting API Suppliers

Product Quality and Compliance: Preference for suppliers with proven compliance and certification.
Supply Security: Ability to meet large volume requirements with timely deliveries.
Pricing and Contract Terms: Competitive costs aligned with quality standards.
Reputation and Track Record: Historical reliability and customer reviews.
Technical Support: Availability of documentation, regulatory assistance, and technical consultation.

Conclusion

Securing a reliable source of sodium lactate 0.167 molar in plastic containers requires careful evaluation of supplier quality, regulatory compliance, and supply chain stability. Leading global players such as Fresenius Kabi, Baxter, Roquette, and Cargill dominate the market, offering high standards of safety and consistency. Regional manufacturers, especially in China and Asia, also serve as cost-effective alternatives provided their quality controls meet pharmaceutical standards.

Strategic sourcing decisions should prioritize verified regulatory compliance, product specifications, and reliable logistics to ensure uninterrupted supply for clinical and manufacturing needs.

Key Takeaways

The global sodium lactate API market is highly competitive, with top suppliers offering high-quality solutions in plastic containers suitable for pharmaceutical use.
Ensuring compliance with international pharmacopeias is crucial for API sourcing, especially for sterile applications.
Supply chain resilience involves diversifying suppliers and establishing long-term contracts aligned with quality and regulatory demands.
Cost is important, but regulatory compliance and consistent product quality are paramount for critical pharmaceutical applications.
Emerging regional suppliers in Asia present both opportunities and challenges, emphasizing the importance of due diligence in quality assurance.

Frequently Asked Questions

1. What are the primary criteria for choosing a sodium lactate supplier for pharmaceutical applications?
Quality certifications (cGMP, ISO, pharmacopeia compliance), product consistency, regulatory approval, supply capacity, and competitive pricing are essential determinants.

2. Can sodium lactate solutions in plastic containers be used for injectable drugs?
Yes, if produced under sterile conditions and compliant with pharmacopeial standards, sodium lactate solutions in plastic containers are suitable for intravenous use.

3. What are typical concentrations of sodium lactate used in pharmaceuticals?
Concentrations vary from 0.15 to 0.167 molar (roughly 1.0%) in infusion solutions, with 0.167 M being a common clinical concentration.

4. Are regional suppliers a reliable alternative for sourcing sodium lactate?
Regional suppliers in Asia, especially China and India, can be reliable if they hold appropriate certifications, provide consistent quality, and have transparent quality control processes.

5. How does packaging in plastic containers influence the stability of sodium lactate solutions?
Plastic containers are generally compatible and do not react with sodium lactate, provided they are manufactured from pharmaceutical-grade materials, contributing to solution stability and ease of handling.

References

[1] USP Monograph for Sodium Lactate, United States Pharmacopeia.
[2] European Pharmacopoeia (EP) standards for Sodium Lactate.
[3] Cargill Corporate Website, Product Specifications.
[4] Fresenius Kabi Product Catalog, Sodium Lactate Solutions.
[5] Recent market analysis reports on pharmaceutical excipients supply chains, IQVIA, 2022.

Bulk Pharmaceutical API Sources for SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER