Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
USP/EP Grade Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
USP/EP Grade Silicon Dioxide
PRODUCT DETAILS
USP/EP Grade Silicon Dioxide is an internationally compliant pharmaceutical-grade silica fully meeting all standards of USP and EP. Produced by precipitation or fumed process with ultra-low heavy metal content and stable quality, it is designed for export-oriented pharmaceutical preparations and international drug R&D/production.
1.Technical Parameters
Parameters | Details |
Appearance | White, odorless, high-purity powder |
Particle Size | 1–35μm (customizable) |
SiO₂ Content | ≥99.7% |
pH Value (5% suspension) | 3.5–7.5 |
Recommended Dosage | 0.1%–4.0% |
Shelf Life | 24 months |
2.Core Applications
Suitable for export-oriented oral solid preparations (tablets, capsules, granules, powders); meets regulatory requirements of the EU, North America and other regions, and can be directly used for international preparation registration and filing without affecting export testing and certification.
3.Production & Quality Advantages
- Dual certification of GMP and international cGMP, with full-item testing in accordance with USP/EP standards.
- Complete CEP/DMF filing documents, exported to over 80 countries and regions.
- Professional international supply chain service experience for pharmaceutical products.
4.Packaging & Storage
- 20/25kg pharmaceutical-grade moisture-proof barrels with double PE inner film.
- Cool and dry sealed storage; compliant with international pharmaceutical packaging and transportation norms.
5.Frequently Asked Questions (FAQs)
Q: Can this product directly support export preparation registration?
A: Yes, it fully meets USP/EP standards and supports direct international registration and filing.
Q: Which major markets does it apply to?
A: It adapts to the EU, North America and other mainstream global pharmaceutical markets.
6.Enterprise System Certification and Honors
• ISO9001:2015 Quality Management System Certification
• ISO22000:2018 Food Safety Management System Certification
• EU 1333/2008 Compliance Certification, FDA Registration Certification
• JECFA, USP Standard Compliance Certification
• HALAL, KOSHER Certification
• Food Additive Production License
• Import and Export Operation Right Registration Certificate
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
