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Abstract

A REVIEW: QUALITY CONTROL OF RESIDUAL SOLVENTS IN PHARMACEUTICALS

Rajesh Yadav*, Nita Yadav, Murli Dhar Kharya

ABSTRACT

General health hazards associated with solvent exposure include toxicity to the CNS, reproductive organs, liver and kidney function, respiratory problems, cancer, and dermatitis. Diethyl ether, chloroform, and many other solvents (e.g., from gasoline or glues) are used recreationally in glue sniffing, often with harmful long term health effects like neurotoxicity or cancer. Ethanol (grain alcohol) is a widely used and abused psychoactive drug. Methanol can cause permanent blindness and death and also dangerous because it burns with an invisible flame. It is interesting to note that ethanol has a synergistic effect when taken in combination with many solvents. For instance a combination of toluene/benzene and ethanol causes greater nausea/vomiting than either substance alone. Some solvents including chloroform and benzene (an ingredient of gasoline) are carcinogenic. Chronic exposure to organic solvents in the work environment can produce a range of adverse neuropsychiatric effects. For example, occupational exposure to organic solvents has been associated with higher numbers of painters suffering from alcoholism. A major pathway to induce health effects arises from spills or leaks of solvents that reach the underlying soil. Since solvents readily migrate substantial distances, the creation of widespread soil contamination is not uncommon; there may be about 5000 sites worldwide that have major subsurface solvent contamination; this is particularly a health risk if aquifers are affected. The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommended the use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.

Keywords: Organic solvents, Residual solvents, Acceptable limits.


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