Development of standard operating procedure "Quality control of sodium chloride solution 0.9% (350 ml) for infusion (intra-pharmacy preparation) in pharmacy organizations manufacturing pharmaceuticals"

Abstract

To develop a standard operating procedure (SOP) for quality control of 0.9% sodium chloride solution (350 ml) for infusion (intra-pharmacy preparation) in accordance with the requirements of the current regulatory documentation. Materials and Methods. Sodium chloride 0.9% sodium chloride solution (350 ml) for infusion (intra-pharmacy preparation) served as the object of the study. The SOP was developed taking into account the requirements of updated regulatory documents used in the field of quality control of medicines: Federal Law No. 61 dated 12.04.2010 "On Circulation of Medicines", Order of the Ministry of Health of the Russian Federation dated 22.05.2023 No. 249n, Order of the Ministry of Health of the Russian Federation dated 22.05.2023 No. 647n dated 31.08.2016, State Pharmacopoeia XV ed. and GOST R 52249-2009. Results. The main stages of the SOP in accordance with the current regulatory documentation are given, reagents, instruments and equipment required for testing are listed, mandatory and sample types of control are indicated. For this dosage form the mandatory controls will be organoleptic, written, control at release, physical and full chemical control. The methods of pH and authenticity tests are described, and the chemistry of qualitative reactions is given. For quantitative determination by the method of argentometry according to Mohr, the method of analysis is given, chemical reactions occurring during titration, the necessary calculations are made: the titer of silver nitrate solution of sodium chloride, the preliminary volume of titrant, the content of sodium chloride in the dosage form in grams. Permissible content limits are given in accordance with OFS.1.8.0001 "Medicinal preparations of pharmacy manufacture". Based on the results of the SOP development, a working instruction for quality control of sodium chloride solution 0.9% (350 ml) for infusion was drawn up. Conclusion. The presented SOP for quality control of sodium chloride solution 0.9% (350 ml) for infusion (intra-pharmacy preparation) describes the requirements for the organization and conditions of testing in assessing the quality of this dosage form and can be implemented in the work of manufacturing pharmacies as a detailed instruction for intra-pharmacy control.