GC-FID

Residual solvents analysis services we routinely provide include:

• Headspace GC-FID Analysis for Residual Solvents per USP <467>
• Volatile Organic Compound (VOC) Testing by Headspace
• GC-Direct inject

Residual solvents, often referred to as organic volatile impurities (OVIs), constitute a crucial aspect of pharmaceutical production, mainly aiding in the synthesis, purification, and preparation of drug substances. However, their benefits come with a caution: the potential to remain in the final product as residuals. These solvents, depending on their concentration and toxicity, can pose significant health risks, ranging from mild irritations to serious toxicological effects.

These chemicals carry no therapeutic benefits but may pose potential hazards to human health or the environment. As a result, it is crucial to ensure that they are either absent in the products or present only below the recommended acceptable levels.

The testing and management of residual solvents is thus a critical aspect of pharmaceutical manufacturing, governed by stringent regulatory standards globally.  At CA Analytical Testing Services we support this testing in compliance with USP chapter <467> and  ICH Q3C (R8).