PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER pharmaceutical API fine chemical suppliers

Subscribe to access the full database, or Get Started Free
Vendor	Vendor Homepage	Vendor Sku	API Url
RR Scientific	⤷ Get Started Free	R6437859	⤷ Get Started Free
>Vendor	>Vendor Homepage	>Vendor Sku	>API Url

Last updated: November 17, 2025

Introduction

Plasma-Lyte 148, a balanced crystalloid solution, constitutes a broad spectrum of applications across clinical and biomedical settings, including intravenous therapy and fluid resuscitation. Its formulation, primarily comprising electrolytes in water, relies on high-quality bulk Active Pharmaceutical Ingredients (APIs) sourced from established manufacturing entities. Ensuring reliable API sourcing is vital for maintaining product efficacy, safety, and regulatory compliance. This article explores the key API sources for plasma physiologically balanced solutions like Plasma-Lyte 148, emphasizing ingredients, manufacturing standards, and procurement considerations.

Understanding the Composition of Plasma-Lyte 148

Plasma-Lyte 148 typically contains a mixture of:

Sodium chloride (NaCl)
Potassium chloride (KCl)
Magnesium chloride (MgCl₂)
Sodium acetate (NaC₂H₃O₂)
Sodium gluconate
Water for injection (WFI)

These components collectively replicate plasma electrolyte composition, ensuring isotonicity and physiological compatibility.

Key API Components and Their Sources

1. Sodium Chloride (NaCl)

Role: Main electrolyte component providing sodium and chloride ions.
Source & Manufacturers:

Chemical Grade Suppliers: Leading suppliers such as Sigma-Aldrich (Merck), Acros Organics, and VWR International supply pharmaceutical and USP-grade NaCl.
Bulk API Manufacturers: Companies including Qingdao Seawin Biotech, Nippon Chemical Industrial, and Cytiva (formerly GE Healthcare) manufacture pharmaceutical-grade NaCl in bulk, adhering to USP, EP, or JP standards.
Regulatory Standards: Ensure APIs meet USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia) specifications conforming to pharmacopoeial monographs, indicating the highest purity levels suitable for injectable solutions.

2. Potassium Chloride (KCl)

Role: Provides potassium ions; critical in electrolyte balance.
Source & Manufacturers:

Global Suppliers: PotashCorp, Nikko Chemicals, and Sigma-Aldrich supply pharmaceutical-grade KCl, often procured for injection-grade batches.
Manufacturers: Guangzhou Baiyun Chemical and Anqing Kemi produce bulk KCl meeting pharmaceutical standards, with extensive documentation of purity and contaminant profile compliance.
Regulatory Compliance: Suppliers must demonstrate compliance with pharmacopoeia monographs, purity tests, and certificate of suitability (CEP).

3. Magnesium Chloride (MgCl₂)

Role: Serves as a magnesium electrolyte; critical for cellular function.
Source & Manufacturers:

Trusted Suppliers: Merck KGaA, Sigma-Aldrich, and Thermo Fisher Scientific offer pharmaceutical-grade MgCl₂.
Bulk API Producers: Yunnan Yunlong and Nippon Chemical Industrial are known for manufacturing high-purity magnesium salts, with certification for injectable applications.
Quality Assurance: Strict purity standards, with testing for heavy metals, endotoxins, and residual solvents.

4. Sodium Acetate

Role: Contributes acetate ions, buffering capacity, and osmolarity.
Source & Manufacturers:

Leading Suppliers: Sigma-Aldrich, Cayman Chemical, and VWR supply pharmaceutical-grade sodium acetate.
Bulk Production: Companies such as Shandong Qilu Biological Technology manufacture industrial and pharmaceutical quality sodium acetate with compliance certifications (e.g., GMP).

5. Sodium Gluconate

Role: Provides additional osmolyte and buffering properties.
Source & Manufacturers:

Major Suppliers: Prayon, Fuso Chemical, and Zhejiang Chuangtai produce pharmaceutical-grade sodium gluconate.
Bulk API Producers: Multiple Chinese manufacturers (e.g., Shandong Fuyang), offering GMP-compliant API suitable for parenteral formulations.

Criteria for Selecting API Suppliers

Selecting an API supplier for plasma-lyte formulations involves evaluating:

Regulatory Compliance: APIs must conform to pharmacopoeial standards (USP, EP, JP) and demonstrate batch-to-batch consistency.
GMP Certification: Confirmed Good Manufacturing Practices provide assurance of manufacturing quality and traceability.
Purity & Contaminant Profile: APIs should have low levels of heavy metals, endotoxins, residual solvents, and microbial contamination.
Supply Chain Reliability: Suppliers with robust logistics and inventory management mitigate risks of shortage.
Documentation: Proper certification, Certificates of Analysis (CoA), and stability data are critical.

Global API Sourcing Strategies

Given the widespread demand for plasma-lyte compatible APIs, pharmaceutical companies typically establish a diversified supply chain:

Primary Suppliers: Established multinational pharmaceutical ingredient producers with proven track records (e.g., Merck, Sigma-Aldrich, Thermo Fisher).
Secondary/Alternative Suppliers: Emerging manufacturers in Asia, notably China and India, which have significantly expanded their GMP-compliant API manufacturing capacity.
Bulk Purchasing & Storage: Long-term contracts and centralized storage safeguard against supply disruptions and price volatility.

Regulatory Considerations & International Standards

API sourcing must align with regulatory agencies’ expectations:

FDA (U.S. Food and Drug Administration): Enforces cGMP standards for API manufacturing, requiring comprehensive documentation, validation, and quality testing.
EMA (European Medicines Agency): Similar GMP compliance; additional requirements may include stability data and environmental safety considerations.
WHO (World Health Organization): Recommends stringent quality control and sourcing only from WHO-prequalified suppliers where possible.

Adherence to these standards ensures APIs are suitable for injectable formulations like Plasma-Lyte 148, minimizing the risk of adverse reactions or stability issues.

Manufacturing and Quality Control of Bulk APIs

Manufacturers supplying APIs for plasma-lyte solutions undergo rigorous:

Raw Material Testing: Verifying incoming raw materials for purity and compliance.
Process Validation: Ensuring manufacturing procedures consistently produce APIs meeting specifications.
In-Process Testing: Monitoring critical parameters to maintain quality criteria during production.
Final Product Testing: Confirming potency, purity, endotoxin levels, residual solvents, and microbial contamination meet pharmacopeial standards.

Impacts of API Quality on Plasma-Lyte 148 Production

API quality directly influences:

Product Safety: Contaminants could trigger adverse reactions.
Product Stability: Impurities may accelerate degradation.
Regulatory Approval: Non-compliance can delay or block approval processes.
Cost Efficiency: High-quality APIs reduce batch rejections and recalls.

Emerging Trends & Outlook

The increasing globalization of API manufacturing has enhanced supply diversity. However, regulatory scrutiny has intensified, pushing manufacturers to adopt stricter quality systems and transparency. Digital integration and supply chain traceability are increasingly prioritized to ensure consistent API quality for high-volume solutions like Plasma-Lyte 148.

Key Takeaways

Reliable sourcing of APIs such as sodium chloride, potassium chloride, magnesium chloride, sodium acetate, and sodium gluconate is essential for manufacturing Plasma-Lyte 148.
Preference should be given to suppliers with proven GMP compliance, strict purity standards, and comprehensive documentation.
Establishing diversified supply chains mitigates risks associated with regional shortages or regulatory changes.
Regulatory adherence ensures the APIs are suitable for injectable formulations, safeguarding patient safety and product efficacy.
Continuous quality monitoring, validation, and supplier audits are vital for maintaining high standards across the production lifecycle.

FAQs

1. What are the primary criteria for selecting API suppliers for Plasma-Lyte 148?
Suppliers must demonstrate GMP compliance, meet pharmacopoeial standards (USP, EP, JP), provide comprehensive certification (CoA), and ensure raw material purity with minimal contaminants.

2. Are Chinese API manufacturers suitable for pharmaceutical-grade APIs used in Plasma-Lyte 148?
Yes, many Chinese manufacturers now produce GMP-compliant, high-purity APIs suitable for injectable solutions. Verification of certifications, audits, and QC data is essential.

3. How does API quality impact the stability of Plasma-Lyte 148?
API impurities can catalyze degradation of formulation components, affecting osmolarity, pH, and overall stability, which compromises safety and efficacy.

4. What regulatory standards govern API sourcing for injectable solutions?
The primary standards include USP, EP, and JP pharmacopoeias, complemented by cGMP guidelines from authorities like the FDA and EMA.

5. How can companies mitigate risks associated with API supply disruptions?
Diversification of suppliers, long-term contracts, maintaining safety stock, and rigorous quality assurance practices help ensure continuous API availability.

References

[1] United States Pharmacopeia (USP). Chemical Tests and Assay Specifications for Pharmaceutical APIs.
[2] European Pharmacopoeia (EP). Monographs on Electrolytes and Salts.
[3] World Health Organization (WHO). Guidelines on Good Manufacturing Practices.
[4] Pharmaceutical APIs Market Reports, 2022.
[5] Regulatory Compliance Guidelines for Injectable APIs, FDA and EMA Publications.

Bulk Pharmaceutical API Sources for PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER