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NCL Method PCC-22

By Krishna Kattel1, Jeffrey Clogston

Nanotechnology Characterization Lab

Residual Organic Solvent Analysis in Nanoformulations Using Headspace Gas Chromatography

Listed in Datasets | publication by group NCL Protocols

Version 1.0 - published on 12 Sep 2022 doi:10.17917/QFEP-HD46 - cite this

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Various organic solvents are used in the synthesis of complex drug products (for example, nanomedicines) and in the manufacturing/purification of drug substances and other excipients. Residual organic solvents may originate from the purification of drug materials and cleaning/maintenance of equipment used to manufacture the drug products. These residual organic solvents are considered drug product impurities having no therapeutic benefit. High or inconsistent concentrations of these volatile residual impurities not only pose health risks for patients but also affect the product’s quality. In addition, residual organic solvents can affect the physicochemical properties of therapeutics, such as particle size, dissolution and wettability.

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