Bulk Pharmaceutical API Sources for POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		204099_ALDRICH
Sigma-Aldrich		409316_ALDRICH
Sigma-Aldrich		449989_ALDRICH
Sigma-Aldrich		451029_ALDRICH

Bulk Active Pharmaceutical Ingredient (API) Sources for: Potassium Chloride 20mEq in Plastic Container

Last updated: August 7, 2025

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Introduction

Potassium chloride (KCl) plays a vital role in medical therapy as a replenisher of potassium levels in patients suffering from hypokalemia, cardiac arrhythmias, and as an essential electrolyte in intravenous (IV) solutions. Its formulation as a 20mEq dose in plastic containers is common for IV administration, demanding high-quality bulk API sources that comply with pharmaceutical regulatory standards. This comprehensive review identifies leading API suppliers capable of providing pharmaceutical-grade potassium chloride suitable for large-scale manufacturing in flexible, sterile, and validated container systems.

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Quality and Regulatory Standards for API Suppliers

The procurement of potassium chloride API necessitates strict adherence to quality norms such as USP, EP, JP, or other pharmacopeial standards. Suppliers must demonstrate compliance with GMP (Good Manufacturing Practice), possess robust quality assurance (QA) and quality control (QC) systems, and sustain consistent batch-to-batch quality. Regulatory certifications such as U.S. FDA approval, EMA compliance, or ISO certifications are indicative of supplier reliability and quality assurance.

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Global API Suppliers for Potassium Chloride

1. CEREXA PHARMA S.A. (Spain)

Overview: Recognized for manufacturing high-purity pharmaceutical salts, Cerexa Pharma supplies potassium chloride API complying with pharmacopoeial standards.

Quality Credentials: Certified GMP, USP, EP, and JP compliant. Offers comprehensive stability and purity data to meet stringent regulatory requirements.

Capabilities: Supplies bulk powders suitable for formulation into IV solutions, including 20mEq units in sterile, plastic-compatible forms.

Highlights: Strong global distribution network; consistent quality; flexible packaging options.

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2. Thermo Fisher Scientific (United States/Global)

Overview: Thermo Fisher is a leader in specialty chemicals and pharmaceutical raw materials, offering pharmaceutical-grade potassium chloride.

Quality Credentials: Monitored under cGMP, ISO certifications; meets USP and EP standards.

Capabilities: Provides bulk powders with specifications aligned to sterile pharmaceutical preparations, with customizable packaging solutions including bulk drums and pre-filled containers.

Highlights: Extensive quality control, global manufacturing footprint, reliable supply chain.

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3. Shanghai Wins Color Pharmaceuticals Co., Ltd. (China)

Overview: A major Chinese API manufacturer with comprehensive GMP facilities producing potassium chloride APIs.

Quality Credentials: GMP, ISO 9001, and while primarily focus on domestic markets, exports API globally.

Capabilities: Produces pharmaceutical-grade potassium chloride ≥99% purity suitable for intravenous formulations, adaptable packaging for clinical and commercial needs.

Highlights: Cost-competitive with reliable quality; established export channels.

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4. Sigmaaldrich (United States/Global)

Overview: Part of Merck KGaA group, Sigma-Aldrich offers pharmaceutical-grade potassium chloride APIs, primarily for research but scalable for manufacturing.

Quality Credentials: GMP compliant, with certifications aligning to pharmacopoeial standards.

Capabilities: Supplies high-purity potassium chloride suitable for sterile preparation, in a variety of packaging options.

Highlights: Reputation for quality and consistency; extensive documentation for regulatory submission.

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5. Rotem Pharmaceutical Industry Ltd. (Israel)

Overview: Specializes in API manufacturing with a focus on high-quality inorganic salts, including potassium chloride.

Quality Credentials: GMP-certified, adherent to USP, EP standards.

Capabilities: Offers bulk powder APIs suitable for sterile injectable formulations, custom packaging, and labeling.

Highlights: High purity, reliable supply, international regulatory acceptance.

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Regional API Suppliers and Considerations

Asian Market Suppliers

• Strides Pharma Science Ltd. (India): Offers GMP-compliant potassium chloride API, competitively priced, with proven export experience.

• VitaPharm (India): Known for reliable sourcing of inorganic salts, including high-quality potassium chloride suitable for IV solutions.

European and North American Suppliers

• Focus on suppliers with established regulatory track records, GMP certifications, and consistent product quality.

Emerging Markets and Due Diligence

• Suppliers from emerging markets may offer cost advantages but require thorough validation on quality audits, regulatory approval status, and stability data.

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Packaging and Supply Considerations

Bulk API for medical use must be supplied in a manner conducive to sterile pharmaceutical manufacturing. Common packaging includes:

• Plastic-lined drums or containers: Designed to prevent moisture absorption and contamination.
• Pre-filled syringes or cartridges: Optional for small-volume, ready-to-use formulations.
• Documentation: Certificate of Analysis (CoA), Certificate of Compatibility, and stability data.

Suppliers should provide comprehensive documentation, including batch records, stability data, and microbial contaminants testing, aligning with regulatory expectations for IV API.

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Supply Chain and Regulatory Assurance

Effective sourcing depends on robust supply chain management, especially for critical APIs like potassium chloride. Manufacturers should seek suppliers with:

• Reliable on-time delivery records.

• Capacity to meet large-volume demands.

• Transparent quality management systems.

• Ability to support regulatory filings with validated data.

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Pricing and Lead Time Considerations

Pricing varies based on purity levels, packaging, order volume, and geographic region. Establish long-term partnerships with suppliers capable of scalable supply to avoid disruptions. Lead times can range from 4–12 weeks, depending on supplier location and regulatory clearance.

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Conclusion

Sourcing potassium chloride 20mEq API in bulk necessitates selecting suppliers with proven quality, regulatory compliance, and reliable supply chains. Leading global entities such as Thermo Fisher, Sigma-Aldrich, and Cerexa Pharma offer high-quality APIs suitable for pharmaceutical manufacturing of sterile, plastic-containerized products. Due diligence, validation, and careful supplier vetting are imperative to ensure safety, efficacy, and regulatory compliance of finished IV solutions.

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Key Takeaways

• Prioritize suppliers with GMP certification, pharmacopoeial compliance, and robust QA/QC practices.

• Confirm product specifications, purity, and stability data suitable for IV formulations.

• Engage with vendors capable of consistent bulk supply, flexible packaging options, and transparent documentation.

• Consider regional suppliers for cost-effective sourcing, but ensure thorough validation before procurement.

• Maintain supply chain resilience through diversified supplier relationships and early procurement planning.

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FAQs

1. What are the primary quality standards required for pharmaceutical-grade potassium chloride APIs?
Pharmaceutical-grade potassium chloride APIs should meet USP, EP, or JP standards, including tests for purity, microbial contamination, heavy metals, and endotoxins, alongside documentation like CoA and stability data.

2. Is it feasible to source potassium chloride API from emerging markets?
Yes, suppliers from emerging markets such as India and China can provide high-quality potassium chloride API at competitive prices. However, due diligence on quality certifications and regulatory compliance is essential.

3. What are the key regulatory considerations when sourcing API for IV solutions?
Regulatory considerations include GMP compliance, validation of manufacturing processes, batch traceability, detailed documentation, and adherence to pharmacopoeial standards to ensure safety and efficacy.

4. How does packaging influence API stability and suitability for IV solutions?
Proper packaging, such as moisture-proof, sterile containers, maintains API stability during storage and transport, minimizes contamination, and ensures compatibility with sterile compounding processes.

5. Can bulk potassium chloride API be directly used for manufacturing in sterile IV containers?
Bulk pharmaceutical-grade potassium chloride API typically requires further processing into sterile solutions under controlled conditions before filling into IV containers, to ensure sterility and correct dosing.

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Sources:

[1] U.S. Pharmacopeia (USP).
[2] European Pharmacopoeia (EP).
[3] Cerexa Pharma official website.
[4] Thermo Fisher Scientific product catalog.
[5] Sigma-Aldrich API specifications.