Cleaning verification Analytical techniques

Though in competition with other analytical techniques, CE has proven its potential and necessity to be used for the characterization of small-molecule pharmaceuticals. Due to the versatility of the system, CE can be applied for the determination of physicochemical properties, identification, purity and stability analysis, and cleaning verification of the drug substance, its precursors, process chemicals, the drug product, and its excipients. 

TABLE 15.4 Selective Analytical Techniques for Cleaning Verification with Associated Analytes and Reported LOD, if Available... 

Again the point is that, for any given molecule, the choice of analytical technique may vary. The techniques outlined below may, in general, provide the highest probably of technical success for very stringent acceptance limits. In addition, the techniques are listed in the order of preference for cleaning verification assays that would have an acceptance limit of 50ng/swab (most potent compounds in Table 15.2) or lower, and this will be the focus of the remainder of this chapter. 

Based upon the advantages of the other techniques presented prior to LC-MS, large volume injection HPLC-UV, and HPLC-CAD, the decision to use electrochemical detection would be driven primarily by a unique analytical need, equipment availability and previous experience of the analytical chemist. A complex chemical matrix should not be of concern at most there could be some residual cleaning agent and residual excipients in addition to the active pharmaceutical ingredient. Since the matrix in cleaning verification is typically simple, electrochemical detection would not be the primary detection technique. However, the sensitivity afforded by ECD is excellent and can meet the most stringent of the acceptance limits outlined in Table 15.2. 

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