Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Silicon Dioxide for Pharmaceutical Excipients
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Silicon Dioxide for Pharmaceutical Excipients
PRODUCT DETAILS
Silicon Dioxide for Pharmaceutical Excipients is our dedicated grade for pharmaceutical excipient applications, with an official drug excipient registration number and full compliance with dedicated pharmaceutical excipient standards of global pharmacopoeias. The entire production process follows pharmaceutical cGMP specifications, produced by a refined fumed silica process, with heavy metals, Residue on Ignition, and microbial limits strictly controlled below pharmacopoeia limits. It delivers three core functional benefits: glidant, anti-adherent, and dispersant, perfectly supporting standardized and regulated production of pharmaceutical preparations, and is the preferred excipient for compliant manufacturing for pharmaceutical enterprises.
1. Specifications
Parameter | Details |
Product Name | Silicon Dioxide for Pharmaceutical Excipients |
Appearance | White, ultra-fine fluffy powder with free from grittiness |
Particle Size Range | 5-50μm (dedicated particle size for pharmaceutical preparations) |
Silicon Dioxide Assay | ≥99.5% |
pH Value | 6.0-8.0 (5% aqueous suspension) |
Typical Dosage | 0.1%-2.0% (in compliance with pharmacopoeia limits for medicinal excipients) |
Shelf Life | 24 months (sealed, dry storage) |
Packaging | 10/15kg paper-plastic composite bags |
Samples | Free samples available |
2. Key Applications
This product is purpose-built for use as an excipient in solid oral pharmaceutical dosage forms. It functions as a flow aid and anti-adherent for tablet compression, a flow aid for capsule filling, and a dispersing agent for powder formulations. It also supports improved tablet compressibility and consistent disintegration, eliminating common sticking and picking issues during granulation and tableting processes. It is fully compatible with standardized production of chemical drugs, traditional Chinese medicines, and generic drugs, and fully aligns with cGMP production workflow requirements for pharmaceutical enterprises.
3. Manufacturing Advantages
Our enterprise holds dedicated production qualifications for pharmaceutical excipients, with a cGMP-standardized production workshop featuring full closed-loop production with no direct manual contact. We are equipped with high-end testing equipment including high performance liquid chromatography (HPLC) and microbial limit testers, conducting 28 full-panel tests for pharmaceutical excipients. We hold more than 10 patents related to pharmaceutical excipients, export to over 30 countries and regions, and have extensive experience in the global pharmaceutical excipient supply chain, with a standard 5-10 day lead times.
4. Packaging & Logistics
- Standard Packaging: 10/15kg paper-plastic composite bags with food and drug contact-grade PE inner film for dual moisture-proof and anti-contamination protection.
- Storage & Transportation: Store in a cool, dry, sealed environment, separate from non-medicinal materials. Classified as non-hazardous material, with fully compliant global transportation.
- Labeling: Marked with pharmaceutical excipient registration number, compliance standard, production batch number, expiry date, and pharmaceutical cGMP certification information; multi-language labeling available for customization.
5. Frequently Asked Questions
Q: Does this product have official pharmaceutical excipient registration/ certification?
A: Yes. It holds a domestic CDE pharmaceutical excipient registration number in China, with FDA DMF filed and EDQM CEP certification, fully meeting international compliance requirements for pharmaceutical excipients.
Q: Is it compatible with high-speed tableting, fully automatic capsule filling and other automated production processes?
A: Yes. Its dedicated particle size design is optimized for automated production equipment in pharmaceutical enterprises, and can significantly improve production efficiency for high-speed granulation and tableting.
6.Certifications & Accreditations
- Pharmaceutical Excipient Registration Number
- USP NF, EP Compliance
- CEP Certification
- Pharmaceutical cGMP Certification
- ISO9001:2015; ISO14001
- FDA DMF Filing
- Pharmaceutical Excipient Export Qualification
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
