Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
High Quality Medical Grade Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
High Quality Medical Grade Silicon Dioxide
PRODUCT DETAILS
1. Product Description
Our High Quality Medical Grade Silicon Dioxide is engineered for high-end medical scenarios, produced through fine purification and gas-phase synthesis processes with a purity of ≥99.9%. It achieves zero detection of heavy metals, and its microbial, bacterial endotoxin and other indicators far exceed the medical standards of USP, EP and the Chinese Pharmacopoeia 2025 Edition. Featuring a large specific surface area and strong dispersion stability, it is suitable for high-end, sterile medical preparations and conforms to the international trend of high-end medical raw materials.
2. Technical Parameters
Parameter | Details |
Product Name | High Quality Medical Grade Silicon Dioxide |
Appearance | White, ultra-fine micron-grade, odorless, tasteless, highly fluffy powder |
Particle Size Range | 3-25μm (high-quality medical grade, uniformity ≥96%) |
Silicon Dioxide Content | ≥99.9% |
pH Value | 3.5-7.2 (5% suspension, high-quality medical standard) |
Typical Addition Level | 0.1%-3.5% (in accordance with high-end medical preparation requirements) |
Shelf Life | 24 months |
Packaging | 20kg high-quality medical grade sterile sealed drums |
Sample | Free sample available (sterile packaging with test report) |
3. Application
With core advantages of high quality and high safety, it is suitable for stringent scenarios such as high-end sterile injectable powder, biological preparations and sustained-release medical preparations. It integrates three functions of flow aid, dispersion and adsorption, solving the pain points of high-end medical preparations including poor powder flowability, unstable active ingredients and impurity interference in detection, and meeting the quality requirements of overseas high-end medical enterprises.
4. Factory Advantages
As a National High-Tech Enterprise, we have a dedicated production line for high-quality medical grade silicon dioxide with production in a Class 100 clean room, certified by GMP, cGMP and ISO13485. Equipped with a precision testing laboratory and ICP-MS equipment, we conduct 40-item stringent full-process testing with a batch purity variation of ≤0.05%. We can provide exclusive high-quality medical test reports for customers.
5. Shipping & Packaging
- Standard Packaging: 20kg high-quality medical grade sterile sealed drums with three-layer sterile PE inner liners, featuring aseptic packaging throughout the process to eliminate contamination.
- Storage & Transportation: Store in a cool, dry and sterile environment; non-hazardous chemical, supporting global cold chain/conventional transportation for high-end medical grade products.
- Labeling Specifications: Marked with high-quality medical grade, purity ≥99.9%, sterile, test report number and Chinese & English instructions, suitable for overseas high-end acceptance.
6. Frequently Asked Questions
Q: What is the core difference between this product and ordinary medical grade silicon dioxide?
A: Its purity is upgraded to ≥99.9% with zero detection of heavy metals; its microorganism and bacterial endotoxin indicators far exceed international standards. It is suitable for high-end, sterile medical preparations with more stable quality.
Q: Can international recognized test reports be issued according to the requirements of overseas customers?
A: Yes. We can provide high-quality medical special test reports in accordance with USP and EP standards, and simultaneously supply detailed impurity content data, suitable for international preparation filing.
7. Certifications & Honors
- ISO22000:2018
- ISO9001:2015
- FDA Certification
- SHC HALAL
- OU KOSHER
- 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
