Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Pharmaceutical Grade Precipitated Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Pharmaceutical Grade Precipitated Silicon Dioxide
PRODUCT DETAILS
1. Product Description
Pharmaceutical Grade Precipitated Silicon Dioxide is a high-purity medicinal excipient refined via a premium precipitation process, manufactured in full compliance with pharmaceutical Good Manufacturing Practices (GMP). All critical indicators align with the requirements of the world’s leading pharmacopoeias, including the Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP). Featuring uniform particle size distribution, excellent dispersibility, and strictly controlled heavy metal and microbial residues well below pharmacopoeial limits, this product delivers core glidant, anti-caking, and dispersion functionalities. With stable physicochemical properties and low dosage requirements, it is a cost-effective, universal excipient for the production of solid pharmaceutical dosage forms, ideally suited for bulk procurement by global pharmaceutical manufacturers.
2. Technical Specifications
Parameter | Details |
Product Name | Pharmaceutical Grade Precipitated Silicon Dioxide |
Appearance | White, odorless, tasteless fluffy powder with no gritty texture |
Particle Size Range | 6-60μm (precipitation-specific particle size, customizable) |
Silicon Dioxide Content | ≥99.0% |
pH Value | 6.0-8.0 (5% aqueous suspension) |
Typical Dosage | 0.1%-3.0% (in compliance with pharmacopoeial limits worldwide) |
Shelf Life | 24 months (sealed, stored in a cool, dry place) |
Packaging | 10/20/25kg pharmaceutical-grade paper-plastic composite bags |
Sample | Free samples available |
3. Application
This product is optimally designed for large-scale production of various solid oral dosage forms. As a glidant and anti-caking agent for tablets, capsules, granules, and powders, it effectively reduces inter-particle friction, eliminates sticking during tableting, wall sticking during production, and caking during storage, while improving the precision of capsule filling and tableting processes. It exhibits no interaction with active pharmaceutical ingredients (APIs), and its addition does not adversely impact the disintegration and dissolution profiles of finished dosage forms. It is widely used in the production of generic chemical drugs and traditional Chinese medicine (TCM) preparations.
4. Manufacturing Advantages
Our facility operates a mature, intelligent production line for pharmaceutical-grade precipitated silicon dioxide, certified with pharmaceutical GMP and ISO9001 standards. We are equipped with pharmacopoeia-compliant testing equipment for dedicated inspection of particle size and dispersibility of precipitated powders, ensuring minimal batch-to-batch variation and stable production capacity. With years of experience supplying pharmaceutical excipients to overseas markets, we export to over 30 countries and regions, with a lead time of 5-10 days to meet bulk procurement demands.
5. Packaging, Storage and Shipping
• Standard Packaging: 10/20/25kg pharmaceutical-grade paper-plastic composite bags with a built-in moisture-proof PE inner liner to isolate moisture and impurities;
• Storage and Transportation Requirements: Sealed storage in a cool, dry, and well-ventilated area. Classified as a non-hazardous chemical, it supports global sea and air freight in compliance with international storage and transportation standards for pharmaceutical raw materials;
• Labeling Specifications: Customizable multi-language labels (English/French/Spanish) indicating product name, precipitation process, applicable pharmacopoeial standards, batch number, and expiration date.
6. Frequently Asked Questions
Q: What are the core advantages of pharmaceutical-grade silicon dioxide produced via the precipitation process?
A: Precipitation-processed silicon dioxide features uniform particle size, stable flowability, and high cost-effectiveness, making it ideally suited for large-scale, standardized production of solid dosage forms by pharmaceutical manufacturers.
Q: Does this product meet the index requirements for precipitated silicon dioxide in European and American pharmacopoeias?
A: Yes. The product’s specifications fully comply with the specific requirements for precipitated medicinal silicon dioxide in USP and EP, with corresponding test reports available upon request.
7. Certifications and Honors
- ISO22000:2018
- ISO9001:2015
- FDA Certification
- SHC HALAL Certification
- OU KOSHER Certification
- Food Additive Production License
- National High-Tech Enterprise
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
