Colloidal Silicon Dioxide
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Colloidal Silicon Dioxide
PRODUCT DETAILS
Colloidal Silicon Dioxide is our nano-scale colloidal structure medicinal silica, available in both hydrophilic and hydrophobic grades, fully compliant with dedicated USP and EP standards for colloidal silicon dioxide for colloidal silicon dioxide. Manufactured via fumed nano-scale process, it features ultra-high specific surface area and high surface activity, with heavy metal and microbial residues are strictly controlled within sterile medicinal limits. It delivers core flow aid, suspension, thickening, and binding performance, with exceptional physicochemical stability, perfectly suited for the R&D and production of high-end pharmaceutical preparations, and is a core excipient for innovative formulations.
1.Specifications
Parameter | Details |
Product Name | Colloidal Silicon Dioxide |
Appearance | White, amorphous, ultra-fine colloidal powder |
Particle Size Range | 10-50nm (nano-scale) |
Silicon Dioxide Assay | ≥99.8% |
pH Value | 2.0-8.0 (customizable per hydrophilic/hydrophobic grade) |
Typical Dosage | 0.01%-1.0% (limits for high-end preparations) |
Shelf Life | 18 months (sealed, dry, light-proof storage) |
Packaging | 10kg composite bags |
Samples | Free samples available for all specifications of hydrophilic/hydrophobic grades |
2. Key Applications
This product is purpose-built for high-end pharmaceutical preparations. The hydrophilic grade is ideal as a suspending agent for oral suspensions and injectable preparations, as well as a binder for tablets, enhancing the stability and uniformity of formulations. The hydrophobic grade is optimized as an anti-adherent and flow aid for oily preparations and coating formulations, and can also be used as a carrier for nano-formulations and microsphere delivery systems. It is fully compatible with the R&D and production of high-end innovative formulations including anti-tumor drugs, antibiotics, and biological drugs, with proven ability to improve drug bioavailability.
3. Manufacturing Advantages
Our enterprise operates a R&D center for nano-scale medicinal materials, holding 15 invention patents related to nano-silica materials. We are equipped with high-end testing equipment including specific surface area analyzers and nano-particle size analyzers, with a cGMP-compliant sterile production workshop. We offer customizable hydrophilic/hydrophobic colloidal silicon dioxide, providing one-stop services from laboratory pilot trials to industrial mass production, with high batch-to-batch stability and a 7-15 day lead time.
4. Packaging & Logistics
- Standard Packaging: 10kg composite bags, designed to isolate air, moisture, and light to prevent agglomeration of nano-powder.
- Storage & Transportation: Store in a cool, dry, light-proof, sealed environment, avoid severe vibration. Classified as non-hazardous material, with fully compliant global transportation for sterile materials.
- Labeling: Marked with hydrophilic/hydrophobic grade, nano particle size, sterile/non-sterile classification, and pharmacopoeia execution standard, with detailed user instructions included.
5. Frequently Asked Questions
Q: Do you provide sterile grade colloidal silicon dioxide for injectable production?
A: Yes. Our sterile grade is processed via terminal sterilization, fully meeting pharmaceutical excipient standards for injectables, and can be directly used in the R&D and production of injectable preparations.
Q: Will nano-scale colloidal silicon dioxide experience powder agglomeration?
A: No. It is manufactured via a dedicated anti-agglomeration process, paired with vacuum-sealed packaging, with no significant agglomeration during storage and use.
6. Certifications & Accreditations
- USP NF, EP
- JP Compliance
- Pharmaceutical cGMP Sterile Certification
- FDA DMF Filing
- Nano-Material Production Qualification
- ISO13485 Medical Device Quality Management System
- Invention Patent for Nano-Silica Material Preparation
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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