Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Medicinal Grade Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Medicinal Grade Silicon Dioxide
PRODUCT DETAILS
Product Description
Medicinal Grade Silicon Dioxide is an application-specific pharmaceutical excipient focused on core pharmaceutical performance, dedicated to serving the pharmaceutical formulation sector and fully compliant with mainstream global pharmacopoeia standards for pharmaceutical excipients. Manufactured via a refined fumed process, it features ultra-high purity, excellent dispersibility, and strict control of heavy metals, residue on ignition, with other critical indicators well below pharmacopoeia limits. This product delivers three core functional properties: superior glidant, anti-adherent, and dispersant performance. With exceptional physicochemical stability and no reactivity with active pharmaceutical ingredients, it is an essential excipient for GMP-compliant pharmaceutical manufacturing.
Specifications
Parameter | Specification |
Product Name | Medicinal Grade Silicon Dioxide |
Appearance | White, ultra-fine fluffy powder with no gritty texture |
Particle Size Range | 4-50μm (pharma-grade customized particle size) |
Silicon Dioxide Assay | ≥99.5% |
pH Value | 6.0-8.0 (5% aqueous suspension) |
Typical Dosage | 0.1%-2.0% (within pharmaceutical excipient dosage limits) |
Shelf Life | 24 months (sealed, dry storage) |
Packaging | 10/20kg pharmaceutical-grade paper-plastic composite bags |
Sample | Complimentary samples available |
Application
Specially engineered for the production of solid pharmaceutical dosage forms, this product functions as a glidant and anti-adherent for tablet compression, a glidant for capsule filling, and a dispersant for powder formulations. It effectively resolves common production issues including punch sticking, wall sticking, and caking during granulation and tableting processes, while supporting enhanced tablet compressibility and consistent disintegration performance. Fully compatible with chemical drugs, traditional Chinese patent medicines, generic drugs, and other formulation types, it aligns perfectly with GMP production process requirements for pharmaceutical manufacturers.
Manufacturing Advantages
Our enterprise holds official production qualifications for pharmaceutical excipients, with a GMP-compliant standardized production workshop featuring full closed-loop production without direct manual contact. We have deployed high-end testing equipment to conduct a full 26-item quality inspection for every batch, and hold multiple patents related to pharmaceutical-grade silicon dioxide. With a proven track record of exporting to over 30 countries, rich experience in international pharmaceutical excipient supply, and sufficient stable production capacity, we guarantee a lead time of 5-10 days for global orders.
Shipping & Packaging
• Standard Packaging: 10/20kg pharmaceutical-grade paper-plastic composite bags with food and drug contact-grade PE inner lining for dual moisture-proof and anti-contamination protection;
• Storage & Transportation Requirements: Store in a cool, dry, sealed environment, separate from non-pharmaceutical materials. Classified as non-hazardous goods, supporting compliant global transportation;
• Labeling Specifications: Labeled with pharmaceutical excipient classification, product batch number, expiration date, GMP certification information, with customizable multi-language labeling available.
Frequently Asked Questions
Q: Does this product hold official pharmaceutical excipient registration qualifications?
A: Yes. It has obtained a domestic pharmaceutical excipient registration number in China, and completed FDA DMF filing, fully meeting international regulatory requirements for pharmaceutical excipients.
Q: Will the addition of this product affect the dissolution rate and bioavailability of the pharmaceutical formulation?
A: No. At recommended dosage levels, the product maintains exceptional physicochemical stability, does not react with active pharmaceutical ingredients, and will not interfere with the core performance of the final formulation.
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
