CALS SYSTEM FOR ANALYTICAL MONITORING OF CHEMICAL REAGENTS AND ULTRA-PURE SUBSTANCES FOR THE PHARMACEUTICAL INDUSTRY
Authors:
1.
Nauchnyy centr «Malotonnazhnaya himiya» (NC MTH)
2.
AO Nauchnyy centr «Malotonnazhnaya himiya»
3.
AO Nauchnyy centr «Malotonnazhnaya himiya»
4.
Nauchnyy centr «Malotonnazhnaya himiya» (NC «MTH»)
5.
Kazan National Research Technological University
Kazan, Russian Federation
Kazan, Russian Federation
Type:
Article
eLocation:
Status:
Published
Received:
05.08.2025
Accepted:
07.08.2025
Published:
07.08.2025
Language:
Russian
Keywords:
CHEMICAL REAGENTS, HIGHLY PURE SUBSTANCES, CALS SYSTEM, ANALYTICAL MONITORING, PHARMACEUTICAL INDUSTRY
Abstract (English):
A CALS system for analytical monitoring of chemical reagents and highly pure substances has been developed, which is an important stage in ensuring the quality of pharmaceutical products. The system is designed for automated control of key parameters of raw materials, which is especially important in the context of tightening international requirements for the production of drugs. The implementation of such a system allows for continuous monitoring of compliance with the standards for the content of the main substance, impurities and other critical quality indicators. The study included a comparative analysis of the products of the domestic manufacturer ECOS-1 JSC with reagents from leading foreign companies, including PanReac, Merck, Carl Roth and Clearsynth Labs. Particular attention was paid to compliance with international standards, in particular compliance with pharmacopoeial articles, which made it possible to objectively assess the possibility of import substitution of products manufactured by foreign companies with domestic chemical reagents. Among the main monitored parameters, the content of the main substance in acetone of the "chemically pure" brand and the amount of substances that reduce potassium permanganate in isopropyl alcohol of the "chemically pure" brand were considered. For each of these indicators, modern analytical methods for determining quality indicators were proposed, and the corresponding advanced instrumentation was recommended. Automation of analytical control processes allows for the prompt identification of potential problems at various stages of the production process and timely implementation of corrective measures. This not only increases the accuracy of quality control, but also contributes to the overall improvement of the characteristics of the manufactured pharmaceutical products, which ultimately leads to an increase in their competitiveness in the international market.
A CALS system for analytical monitoring of chemical reagents and highly pure substances has been developed, which is an important stage in ensuring the quality of pharmaceutical products. The system is designed for automated control of key parameters of raw materials, which is especially important in the context of tightening international requirements for the production of drugs. The implementation of such a system allows for continuous monitoring of compliance with the standards for the content of the main substance, impurities and other critical quality indicators. The study included a comparative analysis of the products of the domestic manufacturer ECOS-1 JSC with reagents from leading foreign companies, including PanReac, Merck, Carl Roth and Clearsynth Labs. Particular attention was paid to compliance with international standards, in particular compliance with pharmacopoeial articles, which made it possible to objectively assess the possibility of import substitution of products manufactured by foreign companies with domestic chemical reagents. Among the main monitored parameters, the content of the main substance in acetone of the "chemically pure" brand and the amount of substances that reduce potassium permanganate in isopropyl alcohol of the "chemically pure" brand were considered. For each of these indicators, modern analytical methods for determining quality indicators were proposed, and the corresponding advanced instrumentation was recommended. Automation of analytical control processes allows for the prompt identification of potential problems at various stages of the production process and timely implementation of corrective measures. This not only increases the accuracy of quality control, but also contributes to the overall improvement of the characteristics of the manufactured pharmaceutical products, which ultimately leads to an increase in their competitiveness in the international market.
Keywords:
CHEMICAL REAGENTS, HIGHLY PURE SUBSTANCES, CALS SYSTEM, ANALYTICAL MONITORING, PHARMACEUTICAL INDUSTRY
CHEMICAL REAGENTS, HIGHLY PURE SUBSTANCES, CALS SYSTEM, ANALYTICAL MONITORING, PHARMACEUTICAL INDUSTRY
