Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
USP Grade Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
USP Grade Silicon Dioxide
PRODUCT DETAILS
Product Description
USP Grade Silicon Dioxide is an application-specific pharmaceutical excipient manufactured in strict accordance with the United States Pharmacopeia–National Formulary (USP-NF) standards, exclusively designed for the North American market and global regions recognizing USP standards. Produced via a precision fumed process, it achieves the highest pharmaceutical-grade purity, with 100% of critical indicators fully aligned with USP NF pharmacopoeia requirements. Delivering core glidant, anti-caking, and dispersant performance with outstanding physicochemical stability, it is ideally suited for pharmaceutical formulation production by North American pharmaceutical enterprises and manufacturers exporting to the North American market, with superior regulatory compliance for the U.S. market.
Specifications
Parameter | Specification |
Product Name | USP Grade Silicon Dioxide |
Appearance | White, odorless, ultra-fine fluffy powder |
Particle Size Range | 3-45μm (USP standard-compliant particle size) |
Silica Assay | ≥99.5% |
pH Value | 6.5-7.5 (5% aqueous suspension, in full compliance with USP requirements) |
Typical Dosage | 0.1%-2.0% (within USP NF pharmacopoeia limits) |
Shelf Life | 24 months (sealed, dry storage) |
Packaging | 10/20/25kg USP standard paper-plastic composite bags |
Sample | Complimentary samples are available, together with USP standard test reports |
Application
This product is specifically tailored for pharmaceutical formulation production in the North American market and global regions recognizing USP standards. It functions as a high-performance glidant and anti-caking agent for tablets, capsules, and granules, prevents powder caking and die sticking, optimizing filling and tableting accuracy, and all USP-NF requirements for pharmaceutical excipients. Fully compatible with chemical drugs, biologics, generic drugs, and other formulation types, it can be directly used in the production of formulations exported to the North American market.
Manufacturing Advantages
Our enterprise specializes in the R&D and production of USP grade pharmaceutical excipients, compliant with FDA regulations and pharmaceutical GMP guidelines. We have established a dedicated USP standard testing laboratory to conduct full USP compendial testing for every batch of products. With a mature North American supply chain network, export experience covering over 10 North American countries, and long-term cooperative partnerships with local pharmaceutical manufacturers, we can provide official USP-compliant test reports for all orders, with a guaranteed lead time of 7-12 days to meet bulk procurement demands from overseas customers.
Shipping & Packaging
• Standard Packaging: 10/20/25kg USP standard paper-plastic composite bags with built-in moisture-proof inner lining, marked with USP certification identification;
• Storage & Transportation Requirements: Store in a cool, dry, sealed environment. Classified as non-hazardous materials, supporting dedicated North American sea and air freight lines in full compliance with US storage and transportation standards for pharmaceutical raw materials;
• Labeling Specifications: Full English labeling, including product name, USP grade, batch number, test report number, expiration date, and other mandatory information.
Frequently Asked Questions
Q: Does this product fully comply with USP NF pharmacopoeia standards?
A: Yes. All indicators are produced and tested in strict accordance with USP NF standards, and we can provide officially recognized USP-compliant test reports for every batch.
Q: Is this product compatible with automated production processes used by North American pharmaceutical manufacturers?
A: Yes. Its application-specific particle size design is perfectly adapted to automated tableting and capsule filling equipment widely used in North America, effectively improving production efficiency and batch-to-batch consistency of finished products.
Certifications & Qualifications
- ISO 22000:2018
- ISO 9001:2015
- 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
