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28 Sep 2023

What is OVI from Quality and Regulatory perspective?

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OVI stands for  Organic Volatile Impurities which are left over from the manufacture of APIs or drug substances.

Residual solvents in drug substances, excipients, and in drug products (also referred to as organic volatile impurities  or OVIs) are considered impurities that are not removed during  product purification and are possibly left over from the manufacture of active pharmaceutical ingredients (APIs) or drug substances and excipients or the formulation of drug products.

Significance of OVI

Organic Volatile Impurities (OVIs) are volatile organic compounds that may be present as impurities or contaminants in pharmaceuticals, chemicals, or other products. These impurities are of concern because they can pose health risks to consumers, and their presence can affect the quality and safety of the product. OVIs can include various organic compounds, such as solvents, reagents, or byproducts from manufacturing processes.

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.

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