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2026

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Silicon Dioxide USP

Zhongqi (Shandong) Silicon Materials Co., Ltd. offers silicon dioxide that fully complies with the United States Pharmacopeia - National Formulary (USP-NF) standards.


USP-NF Compliant Silicon Dioxide for Pharmaceutical Use

Zhongqi (Shandong) Silicon Materials Co., Ltd. offers silicon dioxide that fully complies with the United States Pharmacopeia - National Formulary (USP-NF) standards. Our USP-grade silicon dioxide is trusted by pharmaceutical manufacturers worldwide for its consistent quality and reliable performance.

USP-NF Specifications Compliance:

  • SiO₂ content: NLT 99.0% and NMT 100.5% (after ignition at 1000°C for 2 hours)
  • Loss on drying: NMT 5.0%
  • Loss on ignition: NMT 8.5%
  • Heavy metals: NMT 10 ppm
  • Arsenic: NMT 3 ppm
  • Microbial limits: Total aerobic count ≤ 100 cfu/g, Total yeast and mold ≤ 10 cfu/g, Escherichia coli absent

Product Range:

  • USP Colloidal Silicon Dioxide (ZLXIDE™ USP Series)
  • USP Precipitated Silicon Dioxide (ZLSIL™ USP Series)
  • USP Silica Gel (ZQSIL™ USP Series)

Quality Control System:

Our USP-grade products undergo rigorous testing in our in-house analytical laboratory, which is equipped with advanced instrumentation. We perform all USP-required tests on each batch, including identification, assay, impurities, and specific tests, to ensure full compliance with USP-NF monographs.

Documentation Support:

We provide comprehensive regulatory documentation for our USP-grade silicon dioxide, including Drug Master Files (DMFs) where applicable, to support our customers' regulatory submissions worldwide.