Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
12
2026
-
03
Microbial Control of Pharmaceutical-Grade Silicon Dioxide: Safety Barrier for High-End Excipients Under Pharmacopoeia Standards
Microbial indicators are the core benchmark for classifying the quality grade of pharmaceutical-grade silicon dioxide, which directly determines its applicability in oral and injectable preparations.
Microbial indicators are the core benchmark for classifying the quality grade of pharmaceutical-grade silicon dioxide, which directly determines its applicability in oral and injectable preparations. Both the Chinese Pharmacopoeia (ChP) and the United States Pharmacopoeia (USP) clearly specify that for medicinal-grade silicon dioxide, the total viable count (TVC) shall be ≤100 CFU/g (Colony-Forming Units per gram), the total fungal count (TFC) shall be ≤10 CFU/g, and Escherichia coli must be "not detected". Forinjectable-grade silicon dioxide products, the TVC requirement is even stricter, at ≤10 CFU/g.
The hazards of microbial contamination are highly concealed: aflatoxin produced by fungal metabolism is high-temperature resistant and difficult to degrade. When entering the human body along with drugs, it accumulates over the long term and may cause cancer; the detection of Escherichia coli indicates the presence of fecal contamination, which may lead to gastrointestinal infections. For this reason, high-end pharmaceutical-grade silica products adopt a full-chain control of "source-process-terminal": raw materials use high-purity silicon sources with a purity of more than 99.5%, the entire production process is carried out in a Class D clean area, microorganisms are eliminated through high-temperature calcination (above 800℃) and aseptic crushing processes, and dual detection by the plate counting method and membrane filtration method is adopted at the terminal to ensure zero missed detection.
The Company's core competitiveness lies in the precision of microbial control: it has established a microbial laboratory compliant with Good Manufacturing Practice (GMP) standards, and developed two major series of "oral grade" and "injectable grade" to meet the needs of different preparations. Among them, the injectable-grade silicon dioxide products have an endotoxin content of ≤0.25 EU/mg (Endotoxin Units per milligram), have passed the verification of the pharmacopoeia sterility test method, and have become the designated excipients for injectable suspensions of many pharmaceutical companies.
Related Blog
Related Downloads
Service E-mail
Sales Add
Jinan City, Shandong Province,China
Production Add
Guangzhou City, Guangdong Province
