Residual Solvents, Their Limits and PDE A Review

The objective of this Review Paper is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The Review Paper recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. Residual solvents in pharmaceuticals are defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by practical manufacturing techniques. Nitin Thorat | Prof. Santosh Waghmare | Dr. Hemant Kamble "Residual Solvents, Their Limits and PDE: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50465.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/50465/residual-solvents-their-limits-and-pde-a-review/nitin-thorat