Method Development For Residual Solvents, Separation Of Isopropyl Alcohol, Dichloromethane, Hexanes, Ethyl Acetate, Toluene, And Chlorobenzene, And Its Validation By Headspace Gas Chromatography. (For Active Pharmaceutical Ingredients, Intermediate And Ra

Abstract

Solvents are widely used during the manufacturing, purification, and processing of  Pharmaceutical substances like active pharmaceutical ingredients and intermediate and  Key raw materials. The residues of these solvents must be removed to the extent possible, as they do not have any therapeutic effect but can cause undesirable effects on the consumers. These solvent residue concentrations should not exceed the limits prescribed in the ICH guidelines. This present review work emphasizes GC-HS techniques being used for the separation method of residual solvents Isopropyl alcohol, Dichloromethane, Hexanes, Ethyl Acetate, Toluene, and Chlorobenzene separation method developed and validated. An accurate, precise, linear, and sensitive method was developed for residual solvent determination by headspace gas chromatography (HSGC) with a flame ionization detector in the Sample.  All residual solvents are quantified using gas chromatography with headspace. As per regulatory guidelines, residual solvents must be controlled for release and all solvent peak well-separated methods developed and validated. CP-Sil 5 CB capillary column, 50 m long × 0.53 mm internal diameter, the 5 μm film thickness was used for analysis with FID detector. The method can be readily used