Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
High Purity Silicon Dioxide Pharmaceutical Excipient
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
High Purity Silicon Dioxide Pharmaceutical Excipient
PRODUCT DETAILS
1. Product Description
Our High Purity Silicon Dioxide Pharmaceutical Excipient is a premium-grade material defined by its ultra-high purity and strict compliance with global pharmaceutical excipient standards. Produced via a refined purification process, it delivers a minimum silicon dioxide purity of 99.2%, with heavy metals, arsenic salts, and other trace impurities well below the stringent limits set by the USP, EP, and Pharmacopoeia of the People's Republic of China (ChP) 2025 Edition. This excipient provides dual functionality as a flow aid and dispersing agent, with exceptional physicochemical stability. It is ideally suited for high-end pharmaceutical manufacturing with rigorous purity requirements, and fully aligns with compliance standards for international high-end formulation registration.
2. Technical Specifications
Parameter | Details |
Product Name | High Purity Silicon Dioxide Pharmaceutical Excipient |
Appearance | White, ultra-fine, odorless, tasteless, high bulk density powder |
Particle Size Range | 1-25μm (customizable for high-purity excipient applications) |
Silicon Dioxide Content | ≥99.8% |
pH Value | 3.5-7.2 (5% suspension, high-purity pharmaceutical excipient standard) |
Typical Dosage | 0.1%-3.5% (in compliance with high-end formulation excipient formula requirements) |
Shelf Life | 24 months |
Packaging | 20/25kg sealed moisture-proof barrels for high-purity pharmaceutical excipient grade |
Sample | Free samples available (in high-purity test-specific packaging) |
3. Application Profile
This excipient’s core advantages lie in its ultra-high purity and tailored compatibility with pharmaceutical excipient specifications. It is optimized for stringent applications including high-end oral solid dosage forms, high-purity active pharmaceutical ingredient (API) supporting processes, and biopharmaceutical excipient use. It resolves common pain points in high-specification formulation manufacturing, including poor powder flowability, uneven dispersion, and impurity interference with analytical testing. It does not impact formulation efficacy or international registration filing, making it an ideal choice for global high-end pharmaceutical manufacturers’ excipient procurement needs.
4. Manufacturing Advantages
We operate a dedicated production line for high-purity pharmaceutical excipients, certified to both GMP and cGMP standards. Our facility is equipped with a specialized ultra-high purity testing laboratory, featuring ICP-MS precision analytical equipment. We implement 40 rigorous in-process quality checks across the entire production workflow, with batch-to-batch purity variation controlled to ≤0.05%. We can provide customized high-purity test reports and full global pharmaceutical excipient compliance documentation to support international formulation registration.
5. Shipping & Packaging
• Standard Packaging: 20/25kg sealed moisture-proof barrels for high-purity pharmaceutical excipient grade, with a three-layer PE inner liner to eliminate impurity contamination and moisture absorption;
• Storage & Transportation Requirements: Store in a cool, dry, dark, sealed and dry environment. Classified as non-hazardous material, supporting both global high-end pharmaceutical cold chain and conventional transportation;
• Labeling Specifications: Marked with ≥99.8% high purity, pharmaceutical excipient classification, pharmacopoeia execution standards, and English descriptions, fully compliant with overseas acceptance criteria.
6. Frequently Asked Questions
Q: What is the core value of the purity difference between this product and standard pharmaceutical grade silicon dioxide?
A: With an higher purity of ≥99.8% and impurity levels far below international pharmacopoeia limits, this product is ready for direct use in the manufacturing of high-end, high-purity formulations, and fully meets the compliance requirements of global high-end pharmaceutical production.
Q: Can you provide specialized pharmaceutical excipient test reports tailored to the requirements of overseas customers?
A: Yes. We can provide customized high-purity pharmaceutical excipient test reports in accordance with USP and EP standards, along with detailed impurity content data, to support international formulation registration filings.
7. 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
