Comparative Analysis of Russian and Foreign Pharmacopoeial Requirements for the Quality Control of Water for Injection: Challenges and Ways of Harmonisation

Abstract

Parenteral dosage forms are dissolved using sterile water for injection whose quality is regulated by special requirements. The lack of a monograph on sterile water for injection in the State Pharmacopoeia of the Russian Federation, as well as the concept of harmonisation of pharmacopoeial standards adopted by the member states of the Eurasian Economic Union (EEU), which promotes the development of a unified system of product quality attributes, test methods and means of control, support the need for and importance of the elaboration of a special document. The aim of the work was to study the possibility of harmonisation of Russian and international pharmacopoeial requirements for the quality control of sterile water for injection used as a solvent for medicinal products. The article presents the results of a comparative analysis of requirements of the nine leading world pharmacopoeias and pharmacopoeias of the EEU member states for the quality control of sterile water for injection (lists of test parameters, norms, test methods). The Russian and foreign requirements for the quality control of sterile water for injection differ both in terms of test parameters and test methods used. The analysis of monographs showed that the quality of sterile water for injection is controlled using 12–18 parameters. The most significant differences in the pharmacopoeial requirements of the EEU member states affect nine quality attributes. The authors propose approaches that are harmonised with international requirements and involve the use of more accurate modern test procedures, optimisation of the list of test parameters and establishment of impurity limits for containers with different capacities in order to prepare a monograph on sterile water for injection for inclusion into the State Pharmacopoeia of the Russian Federation and the EEU Pharmacopoeia.

Keywords

• sterile water for injection
• biological medicinal products
• quality control
• quality attributes