Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Pharmaceutical Grade Fumed Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Pharmaceutical Grade Fumed Silicon Dioxide
PRODUCT DETAILS
1. Product Description
Our Pharmaceutical Grade Fumed Silicon Dioxide is a high-performance pharmaceutical material leveraging the unique advantages of fumed production technology. Manufactured via high-purity silane vapor phase hydrolysis and refining, it delivers a minimum silicon dioxide purity of 99.8%, with an ultra-high specific surface area and strong adsorptive properties. It fully complies with the pharmaceutical standards of USP, EP, and ChP 2025, offering triple functionality as a flow aid, anti-caking agent, and adsorbent. It is ideally suited for high-end pharmaceutical manufacturing scenarios with stringent requirements for raw material adsorptivity and flowability, and fully aligns with international pharmaceutical fumed material standards.
2. Technical Specifications
Parameter | Details |
Product Name | Pharmaceutical Grade Fumed Silicon Dioxide |
Appearance | White, ultra-fine micron-grade fumed powder with strong adsorptive properties |
Particle Size Range | 0.3–15 μm (fumed grade, custom particle size available) |
Silicon Dioxide Content | ≥99.8% |
pH Value | 3.5-7.2 (5% suspension, pharmaceutical fumed grade standard) |
Typical Dosage | 0.1%-3.2% (in compliance with fumed material formulation requirements) |
Shelf Life | 24 months |
Packaging | 20kg sealed moisture-proof barrels for pharmaceutical fumed grade |
Sample | Free samples available (for fumed property testing) |
3. Application Profile
The core advantages of this product stem from its ultra-high specific surface area and strong adsorptive properties delivered by the fumed production process. It is optimized for high-activity APIs, moisture-sensitive formulations, sustained-release preparations, and other high-end pharmaceutical scenarios. It resolves common pain points including poor powder flowability, moisture-induced caking, and unstable active ingredients, while also adsorbing impurities to further enhance formulation purity. It fully meets the stringent raw material performance requirements of global high-end pharmaceutical manufacturers.
4. Manufacturing Advantages
We operate a dedicated production line for pharmaceutical grade fumed silicon dioxide, certified to both GMP and cGMP standards. Our facility is equipped with a specialized fumed property testing laboratory, featuring precision equipment including specific surface area analyzers. We implement 42 rigorous in-process quality checks across the entire production workflow, with strict controls on specific surface area and adsorptive performance, delivering quality that meets international pharmaceutical fumed material standards. We can provide comprehensive fumed property test reports for all batches.
5. Shipping & Packaging
• Standard Packaging: 20kg sealed moisture-proof barrels for pharmaceutical fumed grade, with a 3-layer PE liner to eliminate moisture absorption and impurity contamination;
• Storage & Transportation Requirements: Store in a cool, dry, airtight and dark environment, away from volatile and moisture-sensitive substances. Classified as non-hazardous material, supporting global high-end pharmaceutical-grade transportation;
• Labeling Specifications: Marked with pharmaceutical fumed grade classification, specific surface area parameters, product name, and English descriptions, fully compliant with overseas fumed material acceptance criteria.
6. Frequently Asked Questions
Q: What are the core advantages of the fumed production process over conventional production methods?
A: The fumed process delivers a product with ultra-high specific surface area, strong adsorptive properties, higher purity, and no significant agglomeration. It simultaneously delivers triple functionality as a flow aid, anti-caking agent, and adsorbent, making it ideally suited for the most stringent high-end pharmaceutical manufacturing scenarios.
Q: Can you provide international test reports related to fumed material properties?
A: Yes. We can provide specialized fumed property test reports including specific surface area and adsorptive performance, issued in accordance with USP and EP standards, to support international formulation registration filings.
7. Certifications & Qualifications
- ISO22000:2018
- ISO9001:2015
- FDA Certification
- SHC HALAL Certification
- OU KOSHER Certification
- Food Additive Production License
- National High-Tech Enterprise Certification
Packaging and Shipping
Zhongqi (Guangdong) Silicon Materials Co., Ltd., with over 20 years of experience in the food-grade silica field, is a national high-tech enterprise and a Guangdong Province specialized and innovative enterprise. Trusted by numerous international food giants, it is a leader in high-end food-grade silica. Shandong Zhonglian Chemical Co., Ltd. is Zhongqi's sole officially authorized overseas sales subsidiary.
laboratory
The company has established a world-leading R&D and intelligent manufacturing system, built GMP-standardized workshops, constructed 10,000-ton intelligent production lines, established a national-level testing center equipped with cutting-edge international equipment, and built its own high-standard microbiological testing laboratory. From raw material screening to finished product delivery, the entire process strictly adheres to domestic and international food safety management certifications, achieving simultaneous leadership in both "quality" and "quantity."
Customer Visit
We are committed to silicon dioxide for 20 years, our product is well know in the world and cooperate with some Fortune 500 companies, such as the Nestlé，Yihai Kerry，COFCO，China Resources，Budweiser，Symrise, and so on.
HONOR
In 2021, the company was listed on the Guangdong Stock Exchange, marking the beginning of its international expansion. Today, Zhongqi Silicon Industry, with an open vision, empowers the global food industry's safety system with the power of "Made in China." Going forward, the company will continue to focus on molecular-level safety to ensure peace of mind and, with a global perspective, to create a purer quality of life. Because true strength lies in making invisible protections visible to the world.
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Jinan City, Shandong Province,China
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Guangzhou City, Guangdong Province
