Residual Solvent Analysis

What is Residual Solvent Analysis?

Residual solvents in pharmaceuticals (commonly known as organic volatile impurities or OVIs) are organic volatile chemicals that are either used or produced during the manufacture of active pharmaceutical ingredients, excipients, and drug products.

These products also may become contaminated by such solvents from packaging, storage in warehouses, or from shipping and transportation. Because residual solvents have no therapeutic benefits but may be hazardous to human health and to the environment, one must ensure that they are either not present in the products or are present only below acceptable levels.

However, each pharmacopeia handles residual solvents differently, and their lists of toxic solvents and the corresponding acceptable limits vary, thereby making the development of one data set for drug approval in the European countries, in Japan, and in the United States difficult. In this article, the author discusses the present status of the harmonization efforts by the International Conference on Harmonization (ICH) and provides information about analytical methods.