Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Medical Grade Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Medical Grade Silicon Dioxide
PRODUCT DETAILS
1. Product Description
Medical Grade Silicon Dioxide is a multi-scenario adaptable silicon dioxide for medical applications, manufactured in compliance with medical material-related standards and ChP/USP medicinal standards. Produced via an ultra-pure refining process, it features heavy metal residues far below medical limits, excellent biocompatibility, non-toxicity, and non-irritation. Delivering core glidant, anti-caking, dispersion, and mild film-forming properties with extremely stable physicochemical properties, it is suitable for not only pharmaceutical formulation production but also auxiliary medical consumable scenarios, combining medicinal and medical dual attributes.
2. Technical Specifications
Parameter | Details |
Product Name | Medical Grade Silicon Dioxide |
Appearance | White, ultra-pure, ultra-fine fluffy powder with excellent dispersibility |
Particle Size Range | 4-40μm (medical-specific fine particle size) |
Silicon Dioxide Content | ≥99.5% |
pH Value | 6.0-8.0 (5% aqueous suspension) |
Typical Dosage | 0.05%-2.0% (adjustable based on medical application scenario) |
Shelf Life | 24 months (vacuum-sealed, dry storage) |
Packaging | 5/10/20kg medical-specific vacuum-sealed bags |
Sample | Free samples available with biocompatibility test reports |
3. Application
This product is adaptable to diverse medical application scenarios. On the pharmaceutical formulation side, it can be used as a glidant and anti-caking agent for medical powders, topical medicinal powders, and oral medical preparations. On the medical consumables side, it can be used as an auxiliary raw material for medical powder dressings and pharmaceutical coatings, improving the dispersibility of dressings and the uniformity of coatings. It can also be used for filling assistance in medical capsules. All application scenarios comply with medical material safety standards, with no harmful metabolites produced.
4. Manufacturing Advantages
Our enterprise holds medical material production qualifications, certified with both ISO13485 Medical Device Quality Management System and pharmaceutical GMP standards. We are equipped with specialized testing equipment for medical material biocompatibility, conducting dedicated inspections for cytotoxicity and skin irritation. We have built a medical-grade ultra-pure production workshop, delivering powders with ultra-high purity and extremely low impurities, with dual production capacity for medical raw materials and medicinal excipients. We export to medical material markets in over 20 countries, with a lead time of 7-12 days.
5. Packaging, Storage and Shipping
• Standard Packaging: 5/10/20kg medical-specific vacuum-sealed bags to isolate air and moisture, preventing powder moisture absorption and agglomeration;
• Storage and Transportation Requirements: Sealed storage in a cool, dry, and light-proof place, transported under vacuum-sealed conditions. Classified as a non-hazardous chemical, it complies with international storage and transportation standards for medical materials;
• Labeling Specifications: Labels indicating medical attributes, biocompatibility test qualification mark, applicable standards, and batch number, with full English labeling adapted for overseas medical markets.
6. Frequently Asked Questions
Q: What international standards does the product’s biocompatibility comply with?
A: The product has been professionally tested and complies with the ISO10993 Biological Evaluation of Medical Devices standard, with no cytotoxicity and no skin irritation, meeting the requirements of medical application scenarios.
Q: Can it be used in the production of topical medical disinfectant powders and medicinal dressings?
A: Yes. The product complies with standards for medical topical materials, with excellent dispersibility and high safety, which can effectively improve the application performance of topical medical powders and dressings.
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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Sales Add
Jinan City, Shandong Province,China
Production Add
Guangzhou City, Guangdong Province
