Standardisation of the method of residual organic solvent determination (review)

INTRODUCTION. An important quality attribute of medicines and excipients is the content of residual organic solvents (ROS). The general chapter on ROS (1.1.0008) of the State Pharmacopoeia of the Russian Federation (Ph. Rus.) does not provide analytical procedures for ROS identification, limit tests, and quantitative determination. This impedes the standardisation of approaches to the control of ROS.

AIM. This study aimed to analyse global pharmacopoeial practices for and methodological approaches to the control of ROS in order to prepare a draft general chapter on ROS.

DISCUSSION. According to the comparative analysis of the requirements for the control of ROS of the European Pharmacopoeia, the United States Pharmacopoeia, the Pharmacopoeia of the Eurasian Economic Union, and the Ph. Rus., the current Ph. Rus. general chapter lacks a description of chromatographic systems, and this description should be provided. The validation requirements for the relevant test procedures in neither of the analysed pharmacopoeias include an exhaustive list of equipment characteristics that are necessary and sufficient to satisfy all analytical conditions.

CONCLUSIONS. It is reasonable to harmonise the Ph. Rus. general chapter on ROS (1.1.0008) with global pharmacopoeial approaches to ROS determination by gas chromatography. The authors recommend supplementing the draft general chapter on ROS with analytical procedures for ROS identification, limit tests, and quantitative determination.

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