Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
High-Purity Fumed Pharmaceutical Grade Silicon Dioxide (Full Pharmacopoeia Compliant)
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
High-Purity Fumed Pharmaceutical Grade Silicon Dioxide (Full Pharmacopoeia Compliant)
PRODUCT DETAILS
Product Description
This premium pharmaceutical grade silicon dioxide is a high-purity fumed silica, exclusively designed for stringent pharmaceutical manufacturing requirements. Produced via a refined fumed process, it delivers a minimum SiO₂ assay of 99.7%, with tightly controlled limits for heavy metals, residue on ignition, and all other critical impurities. It fully complies with the monograph requirements of ChP 2025, USP, EP, and Japanese Pharmacopoeia (JP), delivering superior glidant and anti-caking performance for high-end pharmaceutical formulations.
Key Specifications
Parameter | Specification |
Product Name | Pharmaceutical Grade Silicon Dioxide (Premium Fumed Full-Compliant Grade) |
Appearance | White, ultra-fine, odorless, tasteless, fluffy powder |
Particle Size Range | 1–35 μm (customizable) |
SiO₂ Assay | ≥99.7% |
pH (5% Aqueous Suspension) | 3.5–7.5 (global pharmacopoeia compliant) |
Typical Dosage | 0.1%–4% (subject to pharmacopoeia limits and formulation requirements) |
Shelf Life | 24 months |
Packaging | 20/25 kg pharmaceutical-grade sealed moisture-proof drums |
Sample Availability | Complimentary samples available |
Core Applications
This full-pharmacopoeia-compliant grade is optimized for high-end oral solid dosage forms and high-purity API powder manufacturing, where strict regulatory compliance and superior performance are essential. It effectively resolves poor powder flowability and storage caking challenges in high-purity formulation production, with all parameters meeting global pharmacopoeia specifications to support seamless drug product registration and regulatory filing.
Manufacturing Advantages
As a Provincial-level "Specialized, Sophisticated, Distinctive, and Innovative" Enterprise, we operate a dedicated production line for fumed pharmaceutical grade silicon dioxide in a GMP-compliant clean manufacturing workshop. Our in-house laboratory is fully equipped to perform all 32 critical pharmacopoeia tests for every batch, ensuring low batch-to-batch variation and consistent ultra-high quality. We provide full pharmacopoeia-compliant test reports for every batch, fully supporting your drug product registration and regulatory compliance needs.
Packaging, Storage & Logistics
- Standard Packaging: 20/25 kg pharmaceutical-grade sealed moisture-proof drums with dual-layer PE inner liners for maximum moisture and contamination protection.
- Storage & Handling: Store in a cool, dry, light-protected area in tightly sealed original packaging. This product is classified as non-hazardous for global pharmaceutical-grade transportation.
- Labeling: All packaging features full regulatory labeling, including product name, premium pharmaceutical grade, full pharmacopoeia compliance statement, purity, and batch test report number.
Frequently Asked Questions
Q: Which pharmacopoeia standards does this product fully comply with?
A: This premium pharmaceutical grade silicon dioxide fully meets all monograph requirements of ChP 2025, USP, EP, and JP, with every critical parameter falling within strict pharmacopoeia limits.
Q: Can you provide full pharmacopoeia test reports for regulatory filing?
A: Yes. We provide comprehensive, batch-specific full pharmacopoeia test reports, customizable to your required pharmacopoeia standard, to fully support your drug product registration and regulatory filing needs.
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
