Organic solvents in the pharmaceutical industry.
Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, different methods for their removal may be used, provided they fulfill safety criteria. After the drying process, analyses need to be performed to check if amounts of solvents used at any step of the production do not exceed acceptable limits (taken from ICH Guideline or from pharmacopoeias). Also new solvents like supercritical fluids or ionic liquids are developed to replace "traditional" organic solvents in the pharmaceutical production processes.
Grodowska
Katarzyna
K
Jagiellonian University, Faculty of Chemistry, Department of Analytical Chemistry, Ingardena 3, 30-060 Kraków, Poland. kgrodowska@gmail.com
Parczewski
Andrzej
A
D002626:Chemistry, Pharmaceutical; D003257:Consumer Product Safety; D004340:Drug Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004349:Drug Packaging; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D009930:Organic Chemicals / Q000737:chemistry* / Q000302:isolation & purification; D011786:Quality Control; D012997:Solvents / Q000737:chemistry* / Q000302:isolation & purification; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence / Q000379:methods
D009930:Organic Chemicals; D012997:Solvents