Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
USP/EP Certified Pharmaceutical Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
USP/EP Certified Pharmaceutical Silicon Dioxide
PRODUCT DETAILS
1. Product Description
USP/EP certified pharmaceutical silicon dioxide is an high-purity pharmaceutical silicon dioxide with dual certification from the United States Pharmacopeia (USP) and European Pharmacopoeia (EP). Manufactured and tested strictly in accordance with USP-NF and EP monograph standards, each batch of products is attached with a USP/EP certified test report. Featuring high powder purity, extremely low impurity content, stable flowability and excellent biocompatibility, it provides excellent glidant, anti-caking and dispersing properties, with stable physicochemical properties and no harmful residues. Exclusively designed for overseas markets that recognize USP/EP standards including Europe and America, it is fully compliant for formal pharmaceutical dosage form production.
2. Technical Parameters
Parameter | Details |
Product Name | USP/EP certified pharmaceutical silicon dioxide |
Certification Standards | Dual certification from USP NF (United States Pharmacopeia) and EP (European Pharmacopoeia) |
Product Purity | ≥99.5% |
Particle Size Range | 3-45μm (exclusive size for USP/EP standards) |
pH Value | 6.5-7.5 (5% aqueous suspension, complying with USP/EP requirements) |
Typical Addition Level | 0.1%-2.0% (USP/EP pharmacopoeial limit) |
Shelf Life | 24 months (sealed, stored in a cool and dry place) |
Samples | Free samples available with attached USP/EP certified test report |
3. Applications
Core-adapted to overseas markets that recognize USP/EP standards including Europe and America, it can be directly used in the compliance dosage form production of overseas pharmaceutical manufacturers as a glidant, anti-caking agent and suspending agent for tablets, capsules, granular formulations and liquid suspensions. It effectively effectively prevents powder caking, tablet punch adhesion and suspension sedimentation, and improves the stability and uniformity of dosage forms. Complying with the strict requirements of USP/EP for pharmaceutical excipients, it can be directly used for dosage form market access in Europe and America, adapted to various compliance dosage forms including chemical drugs, biological drugs and generic drugs, and also meets the procurement needs of medical traders for exporting to European and American markets.
4. Factory Advantages
We have exclusive production capacity for USP/EP certified pharmaceutical silicon dioxide, certified by USP/EP, Pharmaceutical GMP, with FDA DMF and CEP filing completed. We have built an exclusive production workshop and testing laboratory meeting USP/EP standards, equipped with high-end certification testing equipment. Each batch of products undergoes a full set of USP/EP pharmacopoeial tests with officially recognized certification test reports attached. With mature supply chain channels for Europe and America, we export to more than 15 European and American countries, and have established long-term cooperation with local pharmaceutical manufacturers. A full set of certification qualification documents can be provided with a delivery time of 7-12 days to ensure full regulatory compliance and market access.
5. Shipping & Packaging
- Standard Packaging: 10/20/25kg USP/EP certified special pharmaceutical-grade paper-plastic composite bags with moisture-proof inner liners, marked with USP/EP certification logos.
- Storage & Transportation Requirements: Sealed storage in a cool and dry place, avoiding high temperature and humid environments. Non-hazardous chemical, supporting EU and US dedicated sea/air freight, complying with European and American storage and transportation standards for pharmaceutical raw materials.
- Labeling Specification: Fully English labels marked with product name, USP/EP certification number, test report number, pharmacopoeial standards, batch number and validity period, fully adapted to European and American procurement norms.
6. Frequently Asked Questions
Q: Are the USP/EP certifications of the products valid, and can officially verifiable certification documents be provided?
A: The certifications are fully valid. Each batch of products is attached with a USP/EP certified test report, and officially verifiable certification numbers and filing documents can be provided to ensure the products meet European and American pharmacopoeial requirements.
Q: Can the product be directly used in the dosage form production of European and American pharmaceutical manufacturers to meet market access requirements?
A: Yes. The product has dual USP/EP certification, with all indicators fully complying with European and American pharmacopoeial standards. FDA DMF/CEP filing documents can be provided for direct use in European and American dosage form production and market access.
7. Certifications & Honors
- ISO22000:2018
- ISO9001:2015
- FDA Registration
- SHC HALAL
- OU KOSHER
- Food Additive Production License
- National High-Tech Enterprise
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
