Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
EP Grade Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
EP Grade Silicon Dioxide
PRODUCT DETAILS
Product Description
EP Grade Silicon Dioxide is an application-specific pharmaceutical excipient manufactured in strict accordance with European Pharmacopoeia (EP) standards, exclusively developed for the European Union market and global regions recognizing EP standards. Refined via a precision precipitation process, it features ultra-high purity with extremely low impurity levels, with all critical indicators strictly aligned with EP pharmacopoeia requirements. Delivering core glidant, anti-adherent, and suspending agent performance with exceptional physicochemical stability and excellent biocompatibility, it is fully suitable for pharmaceutical formulation production by EU pharmaceutical enterprises and manufacturers exporting to the EU market, with ensuring full regulatory compliance for EU market access.
Parameter | Specification |
Product Name | EP Grade Silicon Dioxide |
Appearance | White, odorless, ultra-fine fluffy powder |
Particle Size Range | 4-50 μm (EP standard-compliant particle size) |
Silicon Dioxide Assay | ≥99.5% |
pH Value | 6.0-8.0 (5% aqueous suspension, in full compliance with EP requirements) |
Typical Dosage | 0.1%-2.0% (within EP pharmacopoeia limits) |
Shelf Life | 24 months (sealed, dry storage) |
Packaging | 10/20 kg EP standard paper-plastic composite bags |
Sample | Complimentary samples available with EP standard test reports |
Application
This product is specifically engineered for pharmaceutical formulation production in the European Union market and global regions recognizing EP standards. It functions as a high-performance glidant, anti-adherent, and suspending agent for tablets, capsules, and suspensions, effectively resolving powder caking, punch sticking, and suspension layering issues, while improving the stability and uniformity of finished formulations. Fully meeting the strict EP pharmacopoeia requirements for pharmaceutical excipients, it is compatible with chemical drugs, traditional Chinese herbal extracts, generic drugs, and other formulation types, and can be directly used in the production of formulations exported to the EU market.
Manufacturing Advantages
Our enterprise holds full production qualifications for EP grade pharmaceutical excipients, with CEP certification and pharmaceutical GMP accreditation. We have built a dedicated EP standard production workshop and testing laboratory to conduct full-item EP indicator testing for every batch of products. With a mature EU supply chain network, export experience covering over 15 EU countries, and the ability to provide full CEP certification documentation and EP-compliant test reports, we guarantee a lead time of 7–12 days for order delivery to meet the strict procurement standards of EU pharmaceutical manufacturers.
Shipping & Packaging
• Standard Packaging: 10/20kg EP standard paper-plastic composite bags with built-in food and drug contact-grade inner lining, fully compliant with EU packaging material standards;
• Storage & Transportation Requirements: Store in a cool, dry, sealed environment, kept separate from non-pharmaceutical materials. Classified as non-hazardous material, supporting dedicated EU transportation lines;
• Labeling Specifications: Multi-language labeling in English/French/German, including product name, EP grade, batch number, CEP certification number, expiration date, and other mandatory information.
Frequently Asked Questions
Q: Has this product obtained CEP certification, and does it meet EU market access requirements?
A: Yes. It has completed full CEP certification, with all indicators fully compliant with EP pharmacopoeia standards and EU market access regulations for pharmaceutical excipients, enabling direct market entry into the European Union.
Q: Does the biocompatibility of this product meet EP standards?
A: Yes. It has passed professional biocompatibility testing, with no toxicity or irritation, fully meeting the biocompatibility requirements for pharmaceutical excipients specified in the EP pharmacopoeia.
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
