Product Overview
Pharmaceutical Grade Silicon Dioxide (CAS 7631-86-9), also known as colloidal silicon dioxide, is a high-purity amorphous silica widely used as a premium pharmaceutical excipient, antioxidant stabilizer, glidant, and anti-caking agent. Manufactured under strict GMP and ICH Q7 guidelines, this pharma-grade silica meets USP, EP, BP and FDA standards, featuring ultra-low heavy metal content, high specific surface area and excellent chemical inertness.
Different from industrial-grade silica, our pharmaceutical-grade silicon dioxide adopts fully purified production processes with strictly controlled impurity indicators. It effectively improves powder fluidity, prevents moisture agglomeration, stabilizes active ingredients, and enhances the shelf life and efficacy stability of pharmaceutical formulations, making it a core auxiliary material for tablets, capsules, granules and oral liquid preparations.
Product Specific Specifications (Standard Grade)
Below are the authoritative and stable technical specifications for our Pharmaceutical Grade Silicon Dioxide CAS 7631-86-9:
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CAS Number: 7631-86-9
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Molecular Formula: SiO₂
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Molecular Weight: 60.08 g/mol
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Appearance: White, fluffy, amorphous ultrafine powder
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Purity: ≥99.5%
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Particle Size: 7–40 nm
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Specific Surface Area: 200–400 m²/g
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Loss on Drying (105°C): ≤7.0%
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Loss on Ignition (1000°C): ≤6.0%
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Whiteness: ≥95%
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Sieve Residue (325μm): ≥98%
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Water Absorption: ≥42ml/20g
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Heavy Metal Limit: Pb ≤1ppm, As ≤1ppm, Cd ≤0.5ppm, Hg ≤0.5ppm
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Solubility: Insoluble in water and organic solvents
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Grade Standard: USP / EP / BP / FDA / ICH Q7 compliant
Core Functions & Advantages
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Antioxidant & Stabilizing Performance: Effectively adsorbs free radicals and moisture in pharmaceutical formulations, delays active ingredient oxidation, prevents drug discoloration and efficacy attenuation, and greatly extends product shelf life.
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Excellent Glidant & Anti-caking Effect: Improves powder fluidity for tablets and capsules, solves material agglomeration caused by moisture absorption, and ensures uniform filling and stable batch production.
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Strong Adsorption & Carrier Property: High specific surface area enables stable adsorption of active drugs, essence and trace components, improving formulation uniformity and drug bioavailability.
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High Safety & Ultra-low Impurity: Strict pharma-grade purification, no harmful residues, far exceeding industrial silica in heavy metal control, fully suitable for long-term pharmaceutical preparation application.
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Good Compatibility: Chemically inert, compatible with most pharmaceutical raw materials, excipients and solvent systems, no chemical reaction or side effects.
Main Pharmaceutical Applications
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Solid Pharmaceutical Preparations: Used as glidant, anti-caking agent and flow aid for tablets, capsules, granules and powder medicines to optimize production efficiency and tablet forming stability.
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Liquid & Semi-solid Preparations: Serves as viscosity modifier, suspending stabilizer and antioxidant auxiliary for oral liquids, suspensions, ointments and creams to prevent delamination and precipitation.
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Healthcare Products: Applied in vitamin tablets, probiotic preparations and nutritional supplements to protect active ingredients from oxidation and moisture damage.
Quality Certification & Packaging
Our Pharmaceutical Grade Silicon Dioxide CAS 7631-86-9 is produced in GMP standardized workshops, compliant with ICH Q7, USP, EP and FDA regulations. Complete COA, quality inspection reports and pharmaceutical-grade qualification documents can be provided for global customer import clearance and registration.
Packaging: 25kg pharmaceutical-grade kraft paper bag with inner food-grade PE lining. Storage: Store in cool, dry and ventilated warehouse, sealed and moisture-proof, avoid direct sunlight and high temperature environment.
FAQ
Q1: What is pharmaceutical grade silicon dioxide CAS 7631-86-9 used for?
A: Pharmaceutical grade silicon dioxide is a high-purity pharmaceutical excipient and antioxidant stabilizer. It is mainly used as glidant, anti-caking agent, flow aid and adsorbent for tablets, capsules and granules. It also acts as a viscosity regulator and antioxidant auxiliary in liquid pharmaceutical preparations to stabilize drug properties and extend shelf life.
Q2: What is the difference between pharmaceutical grade and industrial grade silicon dioxide?
A: Pharma-grade silicon dioxide adopts strict GMP production and high purification process, with ultra-low heavy metal content and no harmful impurities, compliant with USP/EP/FDA pharmaceutical standards. Industrial-grade silica has loose impurity control and cannot be used for drug and health product formulations.
Q3: Is pharmaceutical grade silicon dioxide safe for pharmaceutical formulation? A: Yes. It is chemically inert, non-toxic and non-irritating.
It has passed global pharmaceutical safety certifications and pharmacopoeia standards.
It is a recognized safe auxiliary material for pharmaceutical preparations and will not affect drug efficacy and human safety.
Compatible con redes IPv6
