Silicon Dioxide Excipient for Pharmaceutical Formulations
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Silicon Dioxide Excipient for Pharmaceutical Formulations
PRODUCT DETAILS
1. Product Description
Silicon Dioxide Excipient for Pharmaceutical Formulations is a dedicated medicinal excipient customized for pharmaceutical formulation development and manufacturing. Its production process is optimized for the production needs of different dosage forms including tablets, capsules, and suspensions, with full compliance with ChP, USP, EP, and Japanese Pharmacopoeia (JP) standards. With a moderate specific surface area and low adhesion, it delivers core multi-functional properties including glidant, anti-adherent, and suspending agent effects. It demonstrates exceptional compatibility with various pharmaceutical ingredients and excipients with no compatibility risks, making it the premium excipient of choice for formulation R&D and production by global pharmaceutical enterprises.
2. Technical Specifications
Parameter | Details |
Product Name | Silicon Dioxide Excipient for Pharmaceutical Formulations |
Appearance | White ultra-fine fluffy powder with excellent dispersibility |
Particle Size Range | 4-50μm (customizable based on dosage form type) |
Silicon Dioxide Content | ≥99.5% |
pH Value | 6.5-7.5 (5% aqueous suspension, near-neutral) |
Typical Dosage | 0.05%-2.0% (adjustable based on dosage form) |
Shelf Life | 24 months (sealed, dry storage) |
Packaging | 10/20kg formulation-specific pharmaceutical paper-plastic composite bags |
Sample | Free samples available (customized samples for various dosage forms) |
3. Application
This product is exclusively designed for diverse pharmaceutical formulation scenarios. For oral solid dosage forms, it acts as a glidant and anti-adherent in tableting and capsule filling, eliminating sticking issues during high-speed production. For liquid dosage forms (suspensions), it functions as a suspending agent to prevent API sedimentation and improve the uniformity and stability of formulations. It is compatible with the production of formulations using a wide range of raw materials, including chemical drugs, biologics, and TCM extracts, fully meeting the requirements of GMP-compliant formulation production processes.
4. Manufacturing Advantages
Our enterprise houses a dedicated R&D center for pharmaceutical formulation excipients, capable of customizing powder parameters based on customer’s dosage form and production process. Certified with pharmaceutical GMP and ISO14001 standards, we are equipped with specialized testing equipment for excipient compatibility and full dosage form compatibility testing. Holding more than 20 patents related to medicinal excipients, we have established customized cooperation with multiple overseas formulation enterprises, with a lead time of 5-12 days and full formulation adaptation technical support available.
5. Packaging, Storage and Shipping
• Standard Packaging: 10/20kg formulation-specific pharmaceutical paper-plastic composite bags with dual moisture-proof design to prevent powder moisture absorption and agglomeration;
• Storage and Transportation Requirements: Sealed storage, avoid high temperature and humid environments. Classified as a non-hazardous chemical, it supports global compliant transportation and meets the raw material warehousing standards of formulation enterprises;
• Labeling Specifications: Labels indicating formulation adaptation type, compatibility notes, pharmacopoeial standards, and production batch number, with fully customizable English/multi-language labeling.
6. Frequently Asked Questions
Q: What specialized pharmaceutical formulations can this product adapt to?
A: It is compatible with specialized dosage forms including sustained-release tablets, enteric-coated capsules, and pharmaceutical suspensions, with customizable powder parameters based on unique formulation requirements.
Q: How is the product’s compatibility with common excipients such as lactose and microcrystalline cellulose?
A: It demonstrates exceptional compatibility, with no incompatibility risks with various pharmaceutical fillers and disintegrants, and does not alter the original properties of excipients after mixing.
7. Certifications and Honors
- ISO22000:2018
- ISO9001:2015
- FDA Certification
- SHC HALAL Certification
- OU KOSHER Certification
- 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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