Cleaning validation is the process of assuring that cleaning procedures effectively remove the residue from manufacturing equipment/facilities below a predetermined level. This is necessary to assure the quality of future products using the equipment, to prevent cross-contamination, and as a World Health Organization Good Manufacturing Practices requirement. We have applied the Total Organic Carbon (TOC) analysis method to a number of pharmaceutical products. In this article we discuss the TOC method that we developed for measuring residual amikacin on surface of mixing vessel during manufacturing process. The method with correlation coefficient R² = 0.988 and method offers low detection capability (0.89 parts per million) and rapid sample analysis time. The accurate recovery values ranged from 99.25±1.47 with method precision less than 2%RSD**. We found that the TOC method is applicable for determining residual amikacin on pharmaceutical surfaces and will be useful for cleaning validation.
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