5. Glossary

Residual solvents; residual solvents

Residual solvents are impurities originating from pharmaceutical production and purification processes, which may prove not only toxic but also detrimental to the manufacturability and stability of the finished product. In view of the toxicological consequences, limits have been set by the international ICH organization, and identification and quantification methods are described in pharmacopoeias.

Statique HS- CPG-FID ; Static headspace- gas chromatography- flame ionization detector

This is a characterization and analysis technique based on the separation of volatile compounds by gas chromatography coupled to a flame ionization detector. The sample is introduced into the chromatograph using a headspace technique based on the volatility of the analyte from a static complex matrix....