Pharmaceutical Grade Microcrystalline Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Pharmaceutical Grade Microcrystalline Silicon Dioxide
PRODUCT DETAILS
1. Product Description
Our Pharmaceutical Grade Microcrystalline Silicon Dioxide is a high-performance pharmaceutical material defined by its unique microcrystalline structure advantages. Produced via a specialized microcrystallization preparation and precision classification process, it delivers a minimum silicon dioxide purity of 99.7%, with a uniform crystal structure and high specific surface area. It combines excellent flowability and dispersion stability, with full compliance with USP, EP, and ChP 2025 Edition standards. It is ideally suited for pharmaceutical formulation scenarios requiring uniform dispersion, and fully aligns with the technical requirements of global high-end formulations.
2. Technical Specifications
Parameter | Details |
Product Name | Pharmaceutical Grade Microcrystalline Silicon Dioxide |
Appearance | White, odorless, tasteless microcrystalline powder with uniform dispersion |
Particle Size Range | 5-20μm (microcrystalline specialized, uniformity ≥95%) |
Silicon Dioxide Content | ≥99.7% |
pH Value | 3.5-7.3 (5% suspension, microcrystalline pharmaceutical grade standard) |
Typical Dosage | 0.1%-3.8% (compliant with microcrystalline formulation requirements) |
Shelf Life | 24 months |
Packaging | 20/25kg sealed moisture-proof barrels for pharmaceutical microcrystalline grade |
Sample | Free samples available (for microcrystalline structure testing) |
3. Application Profile
The core advantage of this product is its exceptional dispersion stability delivered by its microcrystalline structure. It is optimized for high-end suspensions, granules, and formulations paired with high-activity APIs, resolving common pain points including uneven dispersion of medicinal powders and stratification during storage. It enhances formulation stability and uniform efficacy delivery, fully meeting the stringent dispersion performance requirements of global high-end formulation manufacturers.
4. Manufacturing Advantages
We operate a dedicated production line for pharmaceutical grade microcrystalline silicon dioxide, certified to both GMP and cGMP standards. Our facility is equipped with a specialized microcrystalline structure testing laboratory, featuring precision equipment including laser particle size analyzers. We implement 38 in-process quality checks across the entire production workflow, with a 100% compliance rate for crystal structure uniformity and exceptional batch-to-batch stability. We can provide comprehensive microcrystalline structure test reports for all batches.
5. Shipping & Packaging
• Standard Packaging: 20/25kg sealed moisture-proof barrels for pharmaceutical microcrystalline grade, with a double-layer PE inner liner to prevent microcrystalline agglomeration and moisture absorption;
• Storage & Transportation Requirements: Store in a cool, dry, dark and airtight environment, avoid severe vibration. Classified as non-hazardous material, supporting global high-end pharmaceutical-grade transportation;
• Labeling Specifications: Marked with pharmaceutical microcrystalline grade classification, crystal uniformity (≥95%), product name, and English descriptions, fully compliant with overseas testing and acceptance criteria.
6. Frequently Asked Questions
Q: What advantages does the microcrystalline structure of this product offer over standard pharmaceutical silicon dioxide?
A: Its uniform crystal structure and high specific surface area deliver significantly stronger dispersion stability, effectively preventing stratification and caking of formulations during storage, improving uniform efficacy delivery, and making it ideally suited for high-end dispersion-type formulations.
Q: Can you customize the microcrystalline particle size to fit specific formulation requirements?
A: Yes. We support customized particle size adjustment within the 5-20μm range, along with microcrystalline structure test reports for the customized particle size, to meet the specific formulation formula needs of overseas customers.
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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