Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
USP-Compliant Pharmaceutical Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
USP-Compliant Pharmaceutical Silicon Dioxide
PRODUCT DETAILS
1. Product Description
Our USP-Compliant Pharmaceutical Silicon Dioxide focuses on USP standard compliance, manufactured via a USP standard-specific refined process with a purity of ≥99.7%. It strictly adheres to USP-NF international pharmacopoeia standards and Chinese Pharmacopoeia (ChP) 2025 Edition pharmaceutical standards, with impurity content and physicochemical indicators fully matching USP requirements. Featuring both glidant and disintegrating functions, it is suitable for all USP-compliant pharmaceutical formulations, aligning with the global USP standard trend for pharmaceutical raw materials.
2. Key Specifications
Parameter | Details |
Product Name | USP-Compliant Pharmaceutical Silicon Dioxide |
Appearance | White, odorless, tasteless, fluffy powder with no impurities and excellent flowability |
Particle Size Range | 1-28μm (USP standard-specific, customizable) |
Silicon Dioxide Content | ≥99.7% |
pH Value | 3.5-7.4 (5% suspension, USP-NF standard) |
Typical Addition Level | 0.1%-3.8% (in accordance with USP standard formulation requirements) |
Shelf Life | 24 months |
Packaging | 20/25kg USP grade pharmaceutical sealed moisture-proof drums |
Sample | Free sample available (with USP standard test report) |
3. Applications
With the core advantage of full compliance with USP-NF international pharmacopoeia standards, it is suitable for all USP-compliant pharmaceutical formulations including oral solid preparations and formulations matched with high-potency active pharmaceutical ingredients (APIs). Featuring both glidant and disintegrating functions, it solves the pain points of poor flowability and slow disintegration of pharmaceutical powders. With impurity content strictly matching USP requirements, it can be directly used for the filing of international USP-compliant formulations, suitable for overseas pharmaceutical enterprises following USP standards.
4. Factory Advantages
We have a dedicated production line for USP standard pharmaceutical silicon dioxide, holding GMP and cGMP certifications. Equipped with a USP special testing laboratory and precision equipment such as ICP-MS, we conduct 36 full-process tests with all indicators complying with USP-NF standards. We can provide special USP standard test reports with strong batch stability, meeting the procurement needs of overseas customers following USP standards.
5. Shipping & Packaging
- Standard Packaging: 20/25kg USP grade pharmaceutical sealed moisture-proof drums with double-layer PE inner liners for moisture and contamination prevention, marked with USP logo.
- Storage & Transportation: Store in a cool, dry, sealed place and away from odorous substances. Non-hazardous chemical, supporting global regular transportation for USP grade pharmaceutical raw materials.
- Labeling Norms: Marked with USP compliant, product name, USP-NF applicable standards, and Chinese-English instructions, complying with overseas acceptance criteria.
6. FAQs
Q: Do all indicators of this product fully match USP-NF standards?
A: Absolutely. All indicators such as purity, impurity content and physicochemical properties strictly follow USP-NF international pharmacopoeia standards, supported by special test reports.
Q: Can it be used for the filing of overseas USP-compliant formulations?
A: Yes. Together with the USP standard special test report, it can be directly used as raw material certification for the filing of USP-compliant formulations, meeting the global filing requirements for USP standard formulations.
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
