1. Product Overview (Product Overview) 1.1 Basic definitions Colloidal silica dioxide is a high-purity silicon dioxide prepared through advanced processes, appearing as a white, loose powder. The product features a core nano-network structure, offering advantages such as uniform particle size, excellent dispersibility, and strong chemical stability. It does not react with active pharmaceutical ingredients. With its high specific surface area and strong inter-particle interactions, silica dioxide serves as a key pharmaceutical excipient to enhance the quality and stability of drug formulations. It finds applications in pharmaceuticals, food, feed, and related fields, while supporting customized performance solutions. 1.2 Core values As a multifunctional pharmaceutical excipient, Zhongqi Colloidal Silica effectively addresses industry challenges such as poor flowability in solid dosage forms and sedimentation issues in liquid preparations. Through comprehensive quality control across the entire production chain, this product ensures consistent purity and performance, empowering pharmaceutical manufacturers to enhance production efficiency and product competitiveness. It is widely compatible with domestic and international drug registration requirements, demonstrating its versatility in meeting diverse regulatory needs. 2. Product Characteristics (Product Characteristics) •Nanostructure: the native particle size is controlled in 12-20nm, forming a uniform three-dimensional network structure, and the BET specific surface area can reach 175-380m²/g, providing the basis for efficient adsorption and dispersion. •Excellent dispersion stability: it can form a stable colloid in the aqueous system, and the pH value is maintained at 3.5-5.5, which is suitable for most API systems. No stratification phenomenon occurs after 30 days of 25℃ standing, meeting the long-term storage requirements of liquid preparations. •Ultra-low impurity residue: SiO₂ content is more than 99.0%, total heavy metal content is less than 25ppm, arsenic content is less than 8ppm, microbial limit is less than 1000CFU/g, far below the industry standard. 4. Application Fields 4.1 Solid dosage forms Tablets, capsules, and powders: These can be uniformly dispersed using standard mixing equipment. The system acts as a barrier to reduce inter-particle interactions, improves free flowability, and prevents caking. It accelerates tablet compression speed while optimizing production processes for smooth powder transportation. The adsorbent/water-absorbing material effectively controls moisture and liquid content (conversion rate depends on dosage). This reduces compatibility issues between pharmaceutical components, promotes uniform distribution of powder constituents, and enhances tablet disintegration speed. •Tablet/capsule: Add 0.1-0.5% as a flow aid, which can reduce the powder resting angle by 20-30%, reduce the weight difference in the tablet process, and improve the hardness of tablets by 15-20% and reduce the brittleness. •Direct tablet process: optimize material flow, reduce the amount of lubricant, shorten the production cycle, suitable for acetaminophen, aspirin and other API systems. 4.2 Liquid preparations Pharmaceutical liquids (gels, creams, suspensions, etc.): Viscosity varies with shear rate, enabling thickening into paste or thinning for easy application. Prevents hard precipitation, sedimentation, and streaking while enhancing gel transparency and raw material distribution uniformity. Improves suspension stability and prevents aerosol sedimentation (requires high-shear equipment for thorough dispersion to achieve optimal performance). •Oral suspension: As a suspending agent and thickener, the addition of 0.5-2.0% can make the sediment volume ratio of API> 95%, prevent drug stratification, and improve the dosage accuracy. •Injections/eye preparations: in line with IPEC-GMP sterile production standards, can enhance the stability of the solution, reduce the risk of particle generation, and adapt to the needs of sensitive liquid preparations. 4.3 Nutritional supplements •Active ingredient carrier: adsorb vitamins, probiotics and other ingredients to extend the shelf life of products and increase the retention rate of biological activity by more than 30%, suitable for protein powder, nutritional powder and other products. •Anti-caking agent: in the environment of humidity ≤60%, the powder material can be kept for more than 6 months without lumping to ensure the fluidity of the product. 4.4 Food applications: As a direct food additive, it enhances the flowability of food powders (including soft organic powders), prevents storage caking while maintaining dryness; adsorbs moisture, suitable for damp/hygroscopic powders; serves as a thickener for liquid foods like pickling juices and vegetable oils, and acts as a thixotropic agent in oil-based baking and cooking sprays; additionally optimizes equipment cleanliness during raw material grinding processes. 4.5 Application in feed field: Optimize feed performance and processing technology to ensure the free flow and storage resistance of supplement powder, and give good moisture adjustment properties to particles; optimize grinding and milling process to prevent product from sticking to equipment. 5. Standards and regulations (Standards & Regulations) •Complies with multiple international pharmacopoeia standards: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and China Pharmacopoeia (ChP 2025). •Obtain relevant qualification certification: FDA inactive ingredient database collection, EU E551 food additive certification. •Follow global compliance guidelines: comply with GMP production specifications and HACCP food safety system requirements. 6. Usage Instructions 6.1 Recommended dosage Type of preparation Functioning purpose Recommended addition ratio Tablet/capsule flow aid 0.1-0.5% Oral suspension Suspension/Thickening agent 0.5-2.0% Nutrient powder antitackiness agent 0.2-1.0% Active ingredient carrier Adsorbent 5-15% 6.2 Key points of operation and storage •Solid preparation application: it is recommended to add after mixing the API and diluent, and use high shear mixing for more than 30 minutes to ensure uniform dispersion. •Application of liquid preparation: it should be dispersed under the condition of pH 4-6, and avoid long-term contact with strong acid and alkali to prevent the destruction of colloid structure. •Storage conditions: sealed package, stored in a dry and cool place (15-25℃, relative humidity <60%), valid for 2 years, open and use as soon as possible. The above information is for reference only, and the actual use and dosage should be adjusted according to your own formula. 7. Product Advantages (PA) •Full scenario adaptation: it has the function of solid preparation flow aid and liquid preparation stability, reduces the type of auxiliary materials and simplifies the formula design. •Global compliance assurance: multi-pharmaceutical code certification coverage, support for domestic and foreign drug registration and declaration, reduce market access risks. •Customized service: according to customer needs, particle size and specific surface area parameters can be adjusted to provide exclusive technical solutions. •Sustainable supply: the production process adopts energy recovery, and the packaging uses recyclable multi-layer paper bags to balance performance and environmental protection needs. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •FDA attestation •FAMI-QS •SEDEX •Food additive production license •Feed additive production license •National high-tech enterprise •Specialized, refined and new enterprises in Guangzhou •28 patents from the State Intellectual Property Office