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10
2026
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04
Application of Pharmaceutical-Grade Silicon Dioxide in Injections: Sterility Control and Endotoxin Removal Technology
Injections have extremely strict requirements on the purity and sterility of excipients.
Injections have extremely strict requirements on the purity and sterility of excipients. Pharmaceutical-grade silicon dioxide needs to achieve "sterility and pyrogen-free" through special processes before it can be used in suspension injections. The entire production process is carried out in a Class B clean area. The raw materials use electronic-grade silica sand (purity 99.9%), which is sterilized by dry heat (180 °C, 2 hours) to kill microorganisms. At the same time, ultrafiltration is used to remove endotoxins, so that the endotoxin content is ≤0.25EU/mg, which complies with the injectable grade standard of the Chinese Pharmacopoeia.
In injections, silicon dioxide is mainly used as a suspension stabilizer to prevent the aggregation and sedimentation of drug particles; its particles are adsorbed on the drug surface to form electrostatic repulsion, so that the suspension will not delaminate after being placed at room temperature for 6 months. For different drugs (such as antibiotics, anti-tumor drugs), the particle size (0.5-5μm) and surface charge can be adjusted to ensure suspension stability.
The Company has a strict quality control system: each batch of injectable-grade products is subject to sterility test, endotoxin test and abnormal toxicity test, and the test data can be traced to the raw material batch. It has passed the GMP certification of the National Medical Products Administration, and has become an excipient supplier for injectable cephalosporin drugs of many domestic pharmaceutical companies, filling the market gap of domestic injectable-grade silicon dioxide.
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