Analysis of Residual Solvents-Impurities by HS-GC-FID: Case of Seven Samples of Ciprofloxacin API.

Residual solvents are organic volatile impurities that can occur in the manufacture of Active Pharmaceutical Ingredients (APIs). analysis pharmaceutical products is necessary not only because they represent a potential risk for human health due to their toxicity and undesirables side effects, but also may affect physicochemical proprieties product. The main objective this work was 29 residual solvents-impurities by Head Space Gas Chromatography with Flame Ionization Detector (HS-GC-FID) seven samples Ciprofloxacin Hydrochloride API, collected from industries installed Algeria. GC equipped flame-ionization detector silica column coated 1.8 µm layer phase G43. carrier gas helium linear velocity 35 cm/s split ratio 1:5. temperature 40 °C then it rised 240 °C. injection 140 250 Twenty-nine belong classes 1 2 were analyzed API whose control mandatory carcinogenic intrinsic toxicity. Only five identified wich Hexane, Toluene, Acetonitrile, Methanol Dichloromethane different samples. All satisfied test identification, so, confirmation quantification procedures weren’t realized. HS-GC-FID technique used showed differ one sample another same molecule. This manufacturers didn’t often use produce which justifies solvent tests usually mentioned specific monographs.