Organic solvents in the pharmaceutical industry.

TLDR

Organic solvents are widely used in the pharmaceutical industry for reactions, separations, purification, and equipment cleaning, but residual solvents are undesirable and must be removed to meet safety criteria, prompting the development of alternatives such as supercritical fluids and ionic liquids. The paper examines the use of organic solvents in active pharmaceutical ingredient and drug product manufacturing. After drying, solvent levels are analyzed to ensure they stay below limits set by ICH guidelines or pharmacopoeias, and new solvents such as supercritical fluids and ionic liquids are being developed to replace traditional organic solvents.

Abstract

Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, different methods for their removal may be used, provided they fulfill safety criteria. After the drying process, analyses need to be performed to check if amounts of solvents used at any step of the production do not exceed acceptable limits (taken from ICH Guideline or from pharmacopoeias). Also new solvents like supercritical fluids or ionic liquids are developed to replace "traditional" organic solvents in the pharmaceutical production processes.