OVI stands for Organic Volatile Impurities which are left over from the manufacture of APIs or drug substances.
Significance of OVI
Examples of OVI
Common examples of OVIs include residual solvents, such as ethanol, methylene chloride, and toluene, which can be used in the manufacturing of pharmaceuticals, and can potentially remain as impurities in the final product.
Sources of OVI
OVIs can originate from various sources. Sources includes raw materials, intermediates, solvents used in the manufacturing process, and degradation products. Moreover, they may also result from environmental contamination during production.
Regulatory Guidelines related to OVI
Regulatory authorities, such as the United States Pharmacopeia (USP) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), provide guidelines and limits for the control of OVIs in pharmaceuticals and related products.