The use of inductively coupled plasma-atomic emission spectroscopy (ICP-AES) in the determination of lithium in cleaning validation swabs.

摘要

The pharmaceutical industry is required to perform cleaning validation studies to verify that equipment used in the manufacture of pharmaceuticals is adequately cleaned from one product or process to the next. Typically, these cleaning validation studies require an analytical method that uses some form of chromatographic technique. In the case of products that may have an inorganic constituent, however, if can often be easier to verify the cleanliness of equipment by using a non-chromatographic technique. A method is described to certify the cleanliness of processing equipment by determining lithium in cleaning validation swabs using inductively coupled plasma-atomic emission spectroscopy (ICP-AES).