The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the impurity analysis of tranexamic acid. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 38 monograph. Resolution between tranexamic acid and impurity C was 3.9 (exceeding USP criteria of not less than 2.0).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay analysis of mefenamic acid. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 38 monograph. The results for column efficiency for the standard solution was 15158 (exceeding the USP criteria of not less than 8200). The tailing factor results for mefenamic acid in standard solution was 0.83 (USP criteria not more than 1.6). The % RSD for replicate injection of standard solution was 0.19% (exceeding the USP criteria not more than 1.0%)

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the assay analysis of lovastatin related compound-A. The analysis was performed on a Thermo Scientific Syncronis C8 HPLC column using the method described in the USP 38 monograph. Resolution between lovastatin and lovastatin related compound A was 10.9 (exceeded USP criteria of NLT 6.0). Relative retention time of lovastatin related compound A with respect to lovastatin was 1.39 (met USP criteria of about 1.3). The % RSD for replicate injection of standard solution was 0.9% (exceed USP criteria not more than 5.0%).

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of ceftriaxone sodium and its impurities. The separation was performed on a Thermo Scientific Syncronis C18 HPLC column using the method described in the USP 38 monograph. The results obtained for resolution and signal to noise ratio exceeded the criteria stated in the USP. Resolution between ceftriaxone sodium and ceftriaxone sodium E isomer peak was 9.99 (USP criteria of not less than 3.0). Signal to noise ratio of ceftriaxone sodium peak in standard solution was 553 (USP criteria not less than 10).

The analysis was performed on a Thermo Scientific Dionex UltiMate 3000 HPLC system and a Thermo Scientific Syncronis aQ HPLC column. All USP criteria was exceeded. Resolution between 2-phenylacetamide and penicillin G potassium was 6.1 (USP criteria of not less than 2.0). Tailing factor for penicillin G potassium was 1.5 (USP criteria not more than 2.0). The % RSD for replicate injections of standard solution was 0.2% (USP criteria not more than 2.0%). The relative retention time of 2 phenylacetamide peak with respect to penicillin G potassium peak was 0.7 (USP criteria about 0.8).