| Customization: | Available |
|---|---|
| CAS No.: | 112945-52-5 |
| EINECS: | 231-545-4 |
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Pharmaceutical grade silicon dioxide, also known as colloidal silicon dioxide or fumed silica, is a highly pure form of silicon dioxide (SiO2) used in the pharmaceutical industry. It has several critical functions in the formulation and manufacturing of pharmaceutical products due to its unique physical and chemical properties.
Purity: Pharmaceutical grade silicon dioxide is highly pure, typically containing over 99.8% silicon dioxide, with very low levels of impurities.
Particle Size: The particles are extremely fine, often in the nanometer range, which contributes to its high surface area.
Amorphous Structure: Unlike crystalline silica, pharmaceutical grade silicon dioxide is amorphous, making it safer for inhalation and reducing the risk of respiratory diseases.
Hydrophilic and Hydrophobic Forms: It can be modified to be either hydrophilic (water-attracting) or hydrophobic (water-repellent), depending on the application requirements.
| Tests | Specification | Result | |||
| Apperance | Light, white powder of extreely fine particle size | Conforms | |||
| Identification | Conforms | Conforms | |||
| Assay,% | 99.0-100.5 | 99.9 | |||
| PH | 3.5~5.5 | 4.3 | |||
| Loss on igntion, % | 2 Max | 1.2 | |||
| Loss on drying, % | 2.5 Max | 0.9 | |||
| The total aerobic microbial count, Cfu/g |
1000 Max | Conforms | |||
| The total combined molds and yeasts count, Cfu/g |
100 Max | Conforms | |||
| Escherichia coli | Can not be detected | Conforms | |||
| Conclusion | It conforms to USP | ||||
10kg/Bag
| Glidant | It is commonly used as a glidant to improve the flow properties of powders during tablet and capsule manufacturing. This ensures uniformity in tablet weight and content. |
| Anti-Caking Agent | Silicon dioxide prevents clumping of hygroscopic powders, ensuring consistent flow and easy processing. |
| Adsorbent Glidant | It can adsorb moisture and other substances, enhancing the stability of sensitive active pharmaceutical ingredients (APIs). |
| Thickening Agent | In liquid formulations, it acts as a thickening agent, providing the desired viscosity and stability to suspensions and gels. |
| Stabilizer | It helps stabilize emulsions and prevent separation of ingredients in complex formulations. |
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