To demonstrate practical approaches that can be used to significantly improve throughput of the cephradine USP assay monograph keeping to the spirit of USP-NF Chapter <621> guidelines while maintaining USP quality acceptance criteria.

Forty-four multi-class veterinary drugs of known concentrations were employed to demonstrate how the use of a generic variable data-independent acquisition (vDIA) method with wide MS/MS precursor isolation windows achieves sensitivity and selectivity comparable to data-dependent MS2 acquisition (using narrow isolation windows) in quantitative and qualitative small molecule applications. In addition, a full record of MS and MS/MS data for the measured sample fit for non-targeted and unknown screening purposes is delivered. vDIA is not available in the United States of America

To describe a new method for veterinary drug analysis, showing how the variable data-independent acquisition (vDIA) workflow achieves high sensitivity and selectivity, providing a complete high-quality data record of the measured sample. Quantitative analysis of the acquired data in combination with non-targeted and unknown screening is shown. vDIA is not available in the United States of America

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of Cefradine and its impurities. The separation was performed on a Thermo Scientific Hypersil Gold column using the method described in the EP 8.0 monograph. Resolution between cefalexin and cefradine was 7.3 (EP criteria of minimum 4.0). Retention time of cefradine was 15.1 minutes (EP criteria of about 15 minutes). The criteria for relative retention time were also exceeded.

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of cefalexin and its impurities. The separation was performed on a Thermo Scientific Hypersil Gold HPLC column using the method described in the EP 8.0 monograph. The results obtained for resolution and tailing factor exceeded the criteria stated in the EP. Resolution between impurity A and B was 5.4 (EP criteria of not less than 2.0). Resolution between cefalexin and cefatoxim was 6.8 (EP criteria of not less than 1.5).