Unmasking the purity: reviewingsources and detection methods of organic volatile impurities

Abstract

Organic Volatile Impurities (OVIs) are residual solvents present in pharmaceutical products as a byproduct of the manufacturing process. These solvents, used in the creation of pharmacological compounds and excipients, often remain in trace amounts in the final medicinal formulations. Their presence is not only a matter of product purity but also of safety, as OVIs can pose significant health risks and environmental hazards. This paper delves into the classification of these residual solvents based on their toxicity levels, offering insights into which solvents are most hazardous and thus require stringent control. It emphasizes the importance of meticulously analyzing these impurities as a critical aspect of quality control in drug production. Additionally, the discussion extends to the methods typically employed for evaluating OVIs, highlighting the limitations of standard production techniques in completely removing these solvents. This leads to a consideration of strategies for minimizing the use of organic solvents in pharmaceutical manufacturing, an essential step towards safer and more sustainable practices. The paper concludes with a look at future trends in detecting and managing OVIs, indicating ongoing developments in this important area of pharmaceutical research and quality assurance.