Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
GMP Grade Pharmaceutical Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
GMP Grade Pharmaceutical Silicon Dioxide
PRODUCT DETAILS
1. Product Description
Our GMP Grade Pharmaceutical Silicon Dioxide is manufactured in strict adherence to GMP production norms via a pharmaceutical-specific refined process, with a minimum purity of 99.7%. It fully complies with the Chinese Pharmacopoeia (ChP) 2025 as well as USP and EP pharmaceutical standards. The entire production process is controlled under a GMP management system, ensuring stable physicochemical properties, excellent glidant and dispersing performance, and no harmful impurity residues. This product is suitable for all GMP-compliant pharmaceutical formulations, aligning with the global GMP compliance trend for pharmaceutical raw materials.
2. Key Specifications
Parameter | Details |
Product Name | GMP Grade Pharmaceutical Silicon Dioxide |
Appearance | White, odorless, tasteless, fluffy powder with excellent flowability |
Particle Size Range | 1-30μm (GMP grade general type, customizable) |
Silicon Dioxide Content | ≥99.7% |
pH Value | 3.5-7.5 (5% suspension, GMP pharmaceutical standard) |
Typical Addition Level | 0.1%-4% (in accordance with GMP formulation requirements) |
Shelf Life | 24 months |
Packaging | 20/25kg GMP grade pharmaceutical sealed moisture-proof HDPE drums |
Sample | Free sample available (with GMP compliance test instructions) |
3. Applications
Core applicable to all GMP-compliant pharmaceutical formulations including oral tablets, capsules, and granules, it features core glidant and dispersing functions, solving the pain points of caking and poor flowability of pharmaceutical powders. Fully compliant with GMP production control requirements, it has excellent compatibility with pharmaceutical raw and auxiliary materials without affecting the efficacy of formulations, and is suitable for the production needs of overseas GMP-certified pharmaceutical enterprises.
4. Factory Advantages
We have a dedicated production line for GMP grade pharmaceutical silicon dioxide, operating in full compliance with the GMP management system and holding dual GMP and cGMP certifications. Equipped with a GMP special testing laboratory, we conduct 32 rigorous full-process tests, and maintain complete production and inspection records for each batch. With stable production capacity, we can provide GMP compliance certificates and test reports, meeting the procurement standards of overseas GMP customers.
5. Shipping & Packaging
- Standard Packaging: 20/25kg GMP grade pharmaceutical sealed moisture-proof HDPE drums with double-layer pharmaceutical-grade PE inner liners for moisture and contamination prevention.
- Storage & Transportation: Store in a cool, dry, sealed and light-protected place. Non-hazardous chemical, supporting global regular transportation for GMP grade pharmaceutical raw materials.
- Labeling Norms: Marked with GMP grade, product name, applicable pharmacopoeia standards, and Chinese-English instructions, attached with batch number, complying with overseas acceptance criteria.
6. FAQs
Q: Does this product fully meet GMP production specification requirements?
A: Absolutely. The production line operates under the GMP management system with full-process control from raw materials to finished products. Complete inspection records are kept for each batch, and GMP compliance certificates are available upon request.
Q: Is it suitable for formulation production of overseas GMP-certified pharmaceutical enterprises?
A: Yes. It complies with international USP and EP pharmacopoeia standards, and together with GMP compliance certificates and test reports, it can meet the filing requirements of overseas GMP 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
