Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Pharmaceutical Grade Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Pharmaceutical Grade Silicon Dioxide
PRODUCT DETAILS
Pharmaceutical Grade Silicon Dioxide is our foundational, universal-grade medicinal silica, serving as a core basic excipient for solid oral pharmaceutical dosage forms. Manufactured via refined precipitation or fumed process, this product features an ultra-high-purity silica base, with heavy metal and microbial contamination levels strictly controlled within global pharmacopoeia limits. It delivers core flow aid and anti-caking performance, with low addition requirements, exceptional physicochemical stability, and strong global regulatory compliance, perfectly meeting the base manufacturing needs of pharmaceutical powder formulations.
1. Specifications
Parameter | Details |
Product Name | Pharmaceutical Grade Silicon Dioxide |
Appearance | White, odorless, tasteless, fluffy powder |
Particle Size Range | 3-60μm (customizable) |
Silicon Dioxide Assay | ≥99.0% |
pH Value | 6.5-7.5 (5% aqueous suspension) |
Typical Dosage | 0.1%-3.0% (in compliance with pharmacopoeia limits worldwide) |
Shelf Life | 24 months (sealed, dry storage) |
Packaging | 10/12.5/15kg paper-plastic composite bags |
Samples | Free samples available |
2. Key Applications
This product delivers two core functions: powder flow enhancement and anti-caking for pharmaceutical manufacturing. When added, it reduces interparticle friction between pharmaceutical powders, eliminates caking issues during the production and storage of solid dosage forms including tablets, capsules, granules, and powders. It optimizes the precision of capsule filling and tableting processes, delivering weight variation control within ±1.5%, making it ideal for large-scale production of universal solid dosage forms for pharmaceutical enterprises. It does not alter the core physicochemical properties of the formulation at recommended dosages.
3. Manufacturing Advantages
As a national-level high-tech enterprise, we operate a ten-thousand-ton intelligent production line for pharmaceutical excipients, equipped with full pharmacopoeia-standard testing equipment. We have established a full pharmacopoeia testing workflow from raw materials to finished products, with certified compliance with pharmaceutical cGMP and ISO9001 quality management systems. Our production delivers stable capacity, minimal batch-to-batch variation, and a 5-10 day lead time, supporting bulk supply of universal medicinal silica for pharmaceutical enterprises worldwide.
4. Packaging & Logistics
- Standard Packaging: 10/12.5/15kg paper-plastic composite bags with pharmaceutical-grade moisture-proof inner film to isolate moisture and impurities.
- Storage & Transportation: Store in a cool, dry, well-ventilated area with sealed packaging. Classified as non-hazardous material, supporting global sea and air freight in compliance with international pharmaceutical excipient storage and transportation standards.
- Labeling: Marked with mandatory legal information including medicinal excipient classification, product batch number, pharmacopoeia execution standard, and production license number; multi-language labeling (English/French/Spanish etc.) available for customization.
5. Frequently Asked Questions
Q: Does this product comply with the world's major pharmacopoeia standards?
A: Yes. Our product specifications fully meet the universal requirements of ChP, USP, EP, JP and other mainstream pharmacopoeias, and can be adapted for pharmaceutical formulation production in most countries and regions worldwide.
Q: Will addition of this product affect the dissolution rate of pharmaceutical preparations?
A: No. At conventional recommended dosages, the product has stable physicochemical properties, does not react with active pharmaceutical ingredients (APIs), and has no adverse impact on the dissolution rate or bioavailability of the formulation.
6. Certifications & Accreditations
- Compliance with ChP
- USP-NF, EP
- Pharmaceutical cGMP Certification
- ISO9001:2015
- FDA DMF Filing
- National High-Tech Enterprise Certification
- Pharmaceutical Excipient Production License
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
