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Ecological Systems and Devices

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CALS System for Environmental Monitoring of Arsenic Impurities in Colloidal Silicon Dioxide for Pharmaceuticals
Bessarabov A.M., Trohin V.E., Gafitulina E.M., Tatarniceva E.V.

A computer-aided quality management system (QMS) was developed for environmental monitoring of arsenic impurities in colloidal
silicon dioxide used in the pharmaceutical industry. Since arsenic is one of the most toxic elements and can accumulate in the body,
an information model was developed to systematize the monitoring of this critical indicator at the following hierarchical levels:
manufacturers, product brands, quality indicators, analytical methods, and analytical equipment. The model is implemented within
a QMS system based on CALS technologies, enabling the integration of disparate data into a unifi ed information space. The system
contains information on modern domestic and foreign instruments capable of performing quantitative analysis in accordance with
pharmacopoeial requirements. The proposed approach can be adapted for monitoring other critical impurities in pharmaceutical
substances.
Keywords: colloidal silicon dioxide, environmental monitoring, CALS system, arsenic impurity, atomic absorption spectrometry, X-ray
fluorescence method, analytical instruments, pharmaceuticals.


DOI: 10.25791/esip.9.2026.1615

Pp. 18-27.

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