Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Pharma Grade Silicon Dioxide Excipient
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Pharma Grade Silicon Dioxide Excipient
PRODUCT DETAILS
1. Product Description
Pharma Grade Silicon Dioxide Excipient is a highly compliant, pharma-exclusive excipient with official registration and filing qualifications for medicinal excipients in domestic and international markets. Manufactured in strict accordance with the specific medicinal excipient standards of USP NF, EP, and ChP via a refined fumed process, it features ultra-high purity and stable flowability, with heavy metals, residue on ignition, and microbial levels well below pharmacopoeial limits. Delivering core glidant, anti-caking, and molding auxiliary functionalities, it is a core fundamental excipient for GMP-compliant production of solid pharmaceutical dosage forms by global pharmaceutical manufacturers.
2. Technical Specifications
Parameter | Details |
Product Name | Pharma Grade Silicon Dioxide Excipient |
Appearance | White fluffy powder, odorless, free of impurities |
Particle Size Range | 3-50μm (pharma excipient-specific particle size) |
Silicon Dioxide Content | ≥99.5% |
pH Value | 6.5-7.5 (5% aqueous suspension) |
Typical Dosage | 0.1%-2.5% (pharmacopoeial limits for medicinal excipients) |
Shelf Life | 24 months (sealed, stored in a cool, dry place) |
Packaging | 10/20/25kg pharma-grade excipient-specific paper-plastic composite bags |
Sample | Free samples available with excipient compliance test reports |
3. Application
This product is primarily used for GMP-compliant production of solid pharmaceutical dosage forms by global pharmaceutical manufacturers. As a core glidant and anti-caking excipient for tablets, capsules, and granules, it improves powder flowability, eliminates tableting sticking, wall sticking, and storage caking issues, while assisting in enhancing tablet moldability and disintegration consistency. It is compatible with the production of various compliant preparations including chemical drugs, generic drugs, and TCM preparations, and can be directly used for market access in Europe, America, Southeast Asia, and other regions worldwide.
4. Manufacturing Advantages
Our enterprise holds exclusive production qualifications for medicinal excipients, with completed FDA Drug Master File (DMF) filing, Certificate of Suitability (CEP) certification, and domestic medicinal excipient registration. We have built a GMP-standardized production workshop with a fully enclosed production process with no direct manual contact. We conduct full 30-item pharmacopoeial testing for each batch, ensuring high batch-to-batch stability. With over 10 years of experience supplying pharmaceutical excipients to overseas markets, we have established long-term cooperation with many well-known pharmaceutical enterprises worldwide, with a lead time of 5-10 days and a full set of compliance qualification documents available.
5. Packaging, Storage and Shipping
• Standard Packaging: 10/20/25kg pharma-grade excipient-specific paper-plastic composite bags marked with medicinal excipient filing numbers, with moisture-proof and anti-damage properties;
• Storage and Transportation Requirements: In compliance with international storage and transportation standards for medicinal excipients, sealed storage in a cool, dry place. Classified as a non-hazardous chemical, it supports global sea and air freight dedicated lines;
• Labeling Specifications: Multi-language labels (English/German/French) including product name, pharma-grade excipient properties, filing number, pharmacopoeial standards, and expiration date.
6. Frequently Asked Questions
Q: What international medicinal excipient compliance qualifications does this product hold?
A: It has completed FDA DMF filing and CEP certification, fully complies with USP and EP standards for medicinal excipients, with a full set of compliance test reports and filing documents available upon request.
Q: Is this product compatible with high-speed automated pharmaceutical production lines of overseas pharmaceutical enterprises?
A: Yes. Its excipient-specific particle size design is optimized for high-speed tableting, fully automatic capsule filling, and other equipment, improving production efficiency and reducing dosage form weight deviation.
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
