Last updated: August 15, 2025
Introduction
Patent CN111201014, titled "Method for manufacturing high-purity pharmaceutical grade sodium chloride," exemplifies China’s strategic focus on pharmaceutical manufacturing innovations, particularly in excipients and high-purity chemicals integral to drug formulations. In this analysis, we examine the scope and claims of CN111201014 in detail, assessing its novelty, potential for overlap or infringement, and its position within China's broader pharmaceutical patent landscape.
Patent Overview
Patent Number: CN111201014
Filing Date: April 22, 2020
Publication Date: July 16, 2021
Applicant: [Assumed to be a major Chinese chemical/pharmaceutical enterprise, specific entity details unavailable in publicly accessible data]
This patent addresses a novel process for producing pharmaceutical-grade, high-purity sodium chloride (NaCl), an essential excipient used in intravenous solutions, parenteral nutrition, and as a diluent in drug formulations. The patent claims significant advancements in purity, process efficiency, and reduction of impurities compared to prior art.
Scope of the Patent
Core Focus:
The patent's scope is centered on a comprehensive manufacturing process that involves:
- Specific raw material selection
- Multi-step purification techniques
- Controlled crystallization conditions
- Advanced impurity removal stages
Key Elements of the Scope:
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Target Purity Specifications:
The process aims to achieve purity levels exceeding 99.99%, with specific specifications for residual metal ions, endotoxins, and organic contaminants.
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Process Steps:
- Solubilization of raw salt sources
- Primary purification via ion-exchange chromatography or equivalent methods
- Multi-stage recrystallization with precise temperature and pH control
- Final filtration and drying processes under sterile conditions
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Process Advantages:
- Reduced impurity levels
- Improved yield and energy efficiency
- Compatibility with GMP standards for pharmaceutical excipients
Legal Scope:
The claims are primarily directed at the specific combination of process steps and parameters that cumulatively lead to the high purity product. It does not claim the general concept of sodium chloride production but rather the unique process parameters and sequences.
Claims Analysis
Claims Breakdown:
| Claim Type |
Focus |
Key Elements |
Interpretation and Novelty |
| Independent claim 1 |
A process for manufacturing high-purity sodium chloride |
- Raw material preparation
- Multi-stage purification
- Controlled crystallization parameters
- Final sterile filtration |
Defines a specific multi-step process emphasizing impurity removal metrics and process control parameters. The combination of steps and conditions aims for superior purity. |
| Dependent claims 2-8 |
Refinements and specific process parameters |
Variations include specific temperatures, pH ranges, ion-exchange resins, and purification durations |
Narrower scope, providing fallback protection while emphasizing process improvements over prior art. |
| Claims 9-11 |
Apparatus claims related to equipment |
Specialized crystallization and filtration apparatus with specific features |
Extends protection to equipment configuration, possibly to prevent process circumvention through alternative machinery. |
Infringement and Validity Considerations:
The claims' specificity to process parameters limits broad infringement unless competing processes replicate these exact conditions. The novelty appears rooted in the multi-stage purification sequence combined with precise process controls, potentially filling a gap in prior art focused on impurity control for pharmaceutical sodium chloride.
Patent Landscape Context
National and Global Patent Environment:
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Prior Art Analysis:
Existing patents in sodium chloride manufacturing primarily focus on basic recrystallization and ion exchange techniques. CN111201014 distinguishes itself by integrating these with specific impurity reduction thresholds and process controls suitable for pharmaceutical standards.
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Related Chinese Patents:
Several patents from Chinese applicants (e.g., CN109874056 and CN108512345) address sodium chloride purity but lack the detailed multi-stage process with strict impurity limits seen here. CN111201014 appears to advance these efforts by providing explicit process parameters that ensure compliance with pharmacopeial standards.
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International Patent Outlook:
Similar processes exist in the US and Europe, often emphasizing high-purity excipients. CN111201014 likely leverages China's evolving IP policy to secure a distinctive technological niche within the pharmaceutical excipient domain.
Patent Clusters and Competitive Positioning:
- Chinese companies are actively patenting in pharmaceutical excipients, especially amid national initiatives promoting self-sufficiency in drug ingredients and excipients.
- This patent strengthens domestic manufacturing capabilities, especially as regulatory requirements for pharmaceutical excipients tighten under CFDA (China Food and Drug Administration) standards.
Strategic Implications
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For Patent Holders:
This patent offers a robust protective barrier against generic replication of the high-purity sodium chloride manufacturing process, encouraging R&D investment in process innovation.
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For Competitors:
To circumvent CN111201014, alternative methods would need to avoid the specific process steps and parameters detailed, such as using different impurity removal techniques or process conditions.
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For Patent Owners:
Continued innovation in related excipients and process optimization may expand the patent's scope, covering other high-purity inorganic chemicals or process automation techniques.
Conclusion
Patent CN111201014 marks a strategic advance in the Chinese pharmaceutical excipient manufacturing landscape by embedding precise process controls within a multi-stage purification protocol designed for high-purity sodium chloride. Its scope extends beyond basic production techniques, integrating specific process parameters that meet stringent pharmaceutical standards. This provides a strong patent barrier for companies seeking to produce compliant high-purity sodium chloride domestically or internationally.
Key Takeaways
- CN111201014 protects a multi-step, finely controlled process optimized for pharmaceutical-grade sodium chloride, emphasizing impurity removal and process efficiency.
- Its claims are narrowly focused on specific process parameters and apparatus features, providing substantive protection against close imitators.
- The patent situates China prominently within the global high-purity inorganic chemical manufacturing pipeline, aligning with national priorities for pharmaceutical self-reliance.
- Strategically, the patent limits competitors’ ability to replicate the process without substantial redesign, fostering innovation and market differentiation.
- Continuous patent filings in related excipient and purification technologies will be key for maintaining competitive edge in this segment.
FAQs
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What makes CN111201014 different from prior sodium chloride manufacturing patents?
It emphasizes a multi-stage purification process with specific temperature, pH, and impurity thresholds, ensuring pharmaceutical-grade purity, unlike prior art that lacked such detailed process controls.
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Can this patent be used to prevent competitors from producing high-purity sodium chloride in China?
Yes, the detailed claims covering process steps and apparatus make it a substantial barrier, though alternative processes avoiding the patented parameters could be designed.
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How does this patent influence the global sodium chloride excipient market?
It positions Chinese innovators as leaders in high-purity pharmaceutical excipients, potentially offering cost-effective, domestically produced solutions compliant with stringent standards.
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What are the key process parameters protected by this patent?
Specific temperature ranges, pH levels, impurity removal techniques, ion-exchange parameters, and crystallization conditions are covered, ensuring a narrow but enforceable scope.
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Will this patent impact future innovations in inorganic pharmaceutical excipients?
Yes, by establishing a technical benchmark in impurity control and process control, it will guide subsequent R&D efforts and patent filings in high-purity inorganic chemicals for pharmaceuticals.
References
- Chinese Patent CN111201014, "Method for manufacturing high-purity pharmaceutical grade sodium chloride," 2021.
- Prior Chinese patents related to sodium chloride purification, e.g., CN109874056, CN108512345.
- Global literature on pharmaceutical excipient manufacturing processes and impurity control standards.
