Research On Determination Of Residual Solvents In Pharmaceuticals And Safety Assessment

Residual solvents are chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. They do not provide therapeutic benefit. So the residual solvents should be removed, to the extent possible, to meet ingredient and product specifications, good manufacturing practices, or other quality-based requirement. In these years, many aspects pay attention to unacceptable toxicities and human carcinogens in residual solvents. In order to protect patients from injuring of the solvents, the content of solvents in such products should be evaluated and justified. The effects of toxic and ecotoxicology of residual solvents should be further study too. The main conclusion of this paper is as follow:1. The second chapter of the paper introduces the method of determination of residual organic solvents in pharmaceutical by capillary gas chromatography. The experimental conditions were DB-624 silica capillary column, FID detector, carrier helium gas and external standard calibration method.Basing on separation, linear curve, and other indicators, the chapter investigated the applicability of this experiment.2. The third ,forth and fifth chapters of the paper based on the experimental methods of second chapter to determine samples which are UP0044, oxytetracyclinum, thiamine hydrochloride and thiamine nitrate. According to different samples, the experimental method made varying degrees of adjustment .In these chapters, residual solvents are not only determined, but also a full set of methodologies experiment are done. The research shows that the methods of determining residual solvents are sensitive, accurate and precision.3. The sixth chapter of the paper introduces the experiment of ecotoxicology.According to this experiment, the five groups of mixed solvents are dived into different degree toxic solvent. And the joint toxicity between solvents and drugs were inspected. By the conclusion of experimental date, security evaluation of these organic solvents is done.