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2026

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Interpretation of Pharmacopoeia Quality Standards for Medicinal Silicon Dioxide: Key Indicators and Testing Methods

Volume IV of the Chinese Pharmacopoeia 2020 Edition clearly stipulates the quality standards for medicinal silicon dioxide.

Volume IV of the Chinese Pharmacopoeia 2020 Edition clearly stipulates the quality standards for medicinal silicon dioxide. Core indicators include identification, assay, impurity limits, microbial limits, and other items, which directly determine whether the product can be used in pharmaceutical preparations. Identification is performed by infrared spectroscopy, requiring the spectrum of the test sample to match that of the reference standard in the range of 4000–400 cm⁻¹ to confirm its amorphous structure.
Assay is determined by thermogravimetric analysis (TGA), with SiO₂ content not less than 99.0% on the ignited basis. Impurity limits are strictly controlled: heavy metals (lead, arsenic) ≤ 10 mg/kg, chloride ≤ 0.1%, sulfate ≤ 0.5%, loss on ignition ≤ 8.5%. Microbial limits are differentiated between oral and injectable grades:
Oral grade: total viable count (TVC) ≤ 1000 CFU/g
Injectable grade: TVC ≤ 10 CFU/g
Escherichia coli and Salmonella shall be absent in both grades.
The Company has comprehensive testing capabilities: it operates a pharmacopoeia-compliant laboratory equipped with Fourier transform infrared spectrometer (FTIR), ICP-MS, microbial incubators and other precision instruments. It can perform all 20 required pharmacopoeia tests, with a testing cycle as short as 24 hours. It provides Pharmacopoeia Compliance Reports to support pharmaceutical enterprises in excipient filing and accelerate their product launch process.

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